FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report Selection Criteria: Product Name: Product Active Ingredient: Active Ingredient Active Moiety: FDA Received Date: .;ACTHAR GEL-SYNTHETIC . .;CORTICOTROPIN . MedDRA® Version* : 17.0 243 Total Cases**: Number of Pages: From: 01-JAN-2001 To: 05-MAY-2014 121 Disclaimer: Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events. *. “MedDRA® Version” refers to the name and version of the dictionary in use at the time the cases were retrieved from the FDA Adverse Event Reporting System (FAERS). MedDRA Medical Dictionary for Regulatory Activities (MedDRA®) is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products. A MedDRA® Preferred Term (PT) is used to standardize a “medical concept” in a report. For example, a report of “heart attack” or “myocardial infarct” are standardized to the same Preferred Term, “Myocardial Infarction”. MedDRA is updated twice a year. **. “Total Cases” reflects the number of individual patient case reports associated with the product of interest that were submitted to FDA within the specified time period. A case consists of an initial report and any follow-up reports submitted to FDA. Because FDA may receive reports on the same patient from more than one source, some of these cases may be duplicate patient reports. Date - Time: 05-05-2014 8:35:59 AM EST Page: 1 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report The information in this report is generated from the FDA Adverse Event Reporting System (FAERS) by using a report query where suspect product(s) or active ingredients are selected from a standardized dictionary and a date range is specified as search criteria. The table below provides the definitions for field headings that are listed on the report. FAERS data have limitations, including the following. There is no certainty that the reported event was actually due to the product. Reports are often incomplete - a blank field means that no data were provided. FDA does not receive reports on all adverse events that occur with a product. Many factors can influence whether or not an event will be reported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population. Field Heading Definition FDA Received Date The date that FDA received the most recent information regarding a case, either as an initial report or follow-up report. The FDA Received Date may not be the same as the date that the event occurred. The event may have occurred days or even months (or years) before the report was sent to (and received by) FDA. Note the displayed date on the report may be later than the query date range if FDA received follow-up information for a case. FDA provides the most current case information available. Case # A unique number assigned by FDA that identifies a FAERS case. A case includes the information received in the initial report plus any additional information received in follow-up reports. Case Type There are three case types in FAERS: Expedited (15-Day): submitted to FDA by manufacturers; these are reports containing serious, unexpected adverse events Nonexpedited: submitted periodically to FDA by manufacturers; these are reports containing adverse events other than those qualifying for expedited (15-day) reporting Direct: submitted “directly” to FDA by healthcare professionals, patients and other consumers Health Professional Indicates whether the initial source who provided information about the event is a health professional (HP). Possible values are; Y - Yes, N – No or the field is blank if it was not reported Outcomes Based on FDA regulations, the reported outcome(s) determines whether a case is serious. The outcome categories include congenital anomaly/birth defect (CA), death (DE), disability (DS), hospitalization (HO), life-threatening (LT), other serious important medical event (OT), and required intervention to prevent permanent impairment/damage (RI). A case can have more than one outcome. The Manufacturer Control Number is the manufacturer’s unique identifier associated with the case. Also referred to as the Company Report Number. Manufacturer Control # Age Sex Country The patient's age, with age unit, based on information provided in the report. Patient sex (Male, Female, Unknown). The country where the event occurred. If not reported, then the country of the reporter. The International Organization for Standardization (ISO) 3166-1 alpha-3 country code is used as an abbreviation for the country. Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 2 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report Field Heading Preferred Term Definition A Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Term (PT) is used to standardize a “medical concept” in a report. For example, a report of “heart attack” or “myocardial infarct” are standardized to the same Preferred Term, “Myocardial Infarction”. MedDRA is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to “code” adverse events, medication errors and other information associated with the use of medical products Product Route Name of a drug or therapeutic biologic in the case report. A product name can appear as either a brand name (trade name) or an active ingredient name, depending on what was reported. There are two roles for products listed on the cases. Suspect (S) identifies the product(s) that the initial reporter deemed most likely to be associated with the event. Concomitant (C) identifies products taken at the same time as the suspect product, but not deemed by the initial reporter as being associated with the event. Reported route of product administration (e.g., oral, topical, injection, sublingual, inhalation). Dosage Text Refers to the amount of the product that was taken or given to a patient, and the frequency of administration. For example, 20 mg twice daily. Duration The length of time the product was used. For example, if someone reported taking Drug A from January 1 to January 30, the duration would be 30 days. Manufacturer The manufacturer of the product, as indicated in the report. Role Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 3 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 3685007 Case # Case Type Health Professional 28-Jun-2001 3685007 NON-EXPEDITED Outcomes Manufacturer Control # HO 200111642US Preferred Term Product Role Route Dosage Text Nausea H.P. ACTHAR S QW Flushing CORTICOTROPIN S 1 CC QW Conjunctival hyperaemia NO INGREDIENT DEFINED (CARDIOVASCULAR SYSTEM) POTASSIUM C Erythema POTASSIUM C Age Sex Country Female USA Duration Manufacturer AVENTIS 30 YR Diarrhoea Electrolyte imbalance Eye irritation Eyelid oedema FDA Received Date 3751110 Case # Case Type Health Professional 10-Jan-2002 3751110 EXPEDITED (15-DAY) Y Outcomes Preferred Term Product Role Route Injection site erythema CORTICOTROPIN S Manufacturer Control # Age Sex Country M0832-2001 57 YR Female ITA Dosage Text Duration Manufacturer Injection site nodule Injection site pain FDA Received Date 3858319 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 01-Jul-2002 3858319 NON-EXPEDITED N HO,RI ACT-S0001 1 YR Female USA Preferred Term Product Role Route Dosage Text Cardiomyopathy H.P. ACTHAR S 30 IU QOD IM INTRAMUSCULAR Duration Manufacturer Hypertension Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 4 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 3871217 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2002 3871217 EXPEDITED (15-DAY) Y HO,OT ZONI000947 5 YR Male JPN Preferred Term Product Role Route Dosage Text Decreased appetite ZONEGRAN S 150 MG DAILY ORAL Calculus urinary ACTH S Convulsion PROPRANOLOL C Electroencephalogram abnormal VALPROATE SODIUM C Flat affect CLONAZEPAM C ORAL Duration Manufacturer .025 MG/KG DAILY Haematuria Laboratory test abnormal Pyelocaliectasis Vomiting FDA Received Date 3942399 Case # Case Type Health Professional Outcomes 29-Apr-2003 3942399 DIRECT Y DE Manufacturer Control # Product Role Route Dosage Text Respiratory arrest ACTH S 40 DOSE UNITS/ DAY INJECTION Vomiting TRIMETHOPRIM/ SULFAMETHOXAXZOLE C Case # Case Type Health Professional Outcomes 29-Apr-2003 3942472 DIRECT Y DE Manufacturer Control # Preferred Term Product Role Route Dosage Text Convulsion ACTH S 60 DOSE UNITS/DAY INJECTIONS Hypertension PYRIDOXINE HYDROCHLORIDE C Respiratory arrest SULFAMETHOXAZOLE AND TRIMETHOPRIM C DIURIL C Date - Time: 05-05-2014 8:35:59 AM EST Sex Country 319 DAY Male Preferred Term FDA Received Date 3942472 Age Note: If the field is blank, there is no data Duration USA Manufacturer Age Sex Country 1 YR Female USA Duration Manufacturer QUESTCOR Page: 5 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 3951730 Case # Case Type Health Professional Outcomes 22-May-2003 3951730 DIRECT Y HO,RI Manufacturer Control # Age Sex Country 91 DAY Female Preferred Term Product Role Route Dosage Text Blood pressure increased CORTICOTROPIN S 20 IU QOD INTRAMUSCULAR INTRAMUSCULAR Duration USA Manufacturer Cardiac disorder Cardiac murmur Hypertrophic cardiomyopathy Ventricular hypertrophy FDA Received Date 3955320 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 26-Jun-2003 3955320 EXPEDITED (15-DAY) Y DE 03-ADE-SU-0002-ACT 304 DAY Male Preferred Term Product Role Route Dosage Text Coma H.P. ACTHAR S 40 UNITS QOD IM Congenital central nervous system anomaly BACTRIM C INTRAMUSCULAR Sex Duration Country USA Manufacturer QUESTCOR Congenital cardiovascular anomaly Respiratory arrest Vomiting FDA Received Date 3955318 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Aug-2003 3955318 EXPEDITED (15-DAY) Y DE 03-ADE-SU-0001-ACT 1 YR Female USA Preferred Term Product Role Route Dosage Text Convulsion ACTHAR S 32 U/ML QOD IM Respiratory arrest BACTRIM C Sudden death DIURIL C PYRIDOXINE HYDROCHLORIDE C Date - Time: 05-05-2014 8:35:59 AM EST INTRAMUSCULAR Note: If the field is blank, there is no data Duration Manufacturer QUESTCOR Page: 6 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 3965651 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Aug-2003 3965651 EXPEDITED (15-DAY) Y HO 03-ADE-SU-0003-ACT 52 YR Female USA Preferred Term Product Role Route Dosage Text Blood pressure increased ACTHAR S 40 UNNITS QD IM Cerebral haemorrhage SUDAFEDRINE, NEURONTIN C Delirium tremens DURGESIC PATCHES C Tremor KLONOPIN C PROVIGIL C PROZAC C NEURONTIN C FDA Received Date 4212236 Case # Case Type Health Professional 09-Sep-2004 4212236 EXPEDITED (15-DAY) INTRAMUSCULAR Duration Manufacturer QUESTCOR Outcomes Manufacturer Control # Age Sex Country OT 234313K04USA 43 YR Female USA Preferred Term Product Role Route Dosage Text Injection site cellulitis REBIF S 44 MCG, 3 IN 1 WEEKS Injection site necrosis ACTH S INTRAMUSCULAR Duration Manufacturer INTRA-MUSCULAR Injection site pain Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 7 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 5662140 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Dec-2004 5662140 EXPEDITED (15-DAY) Y HO,LT PHBS2004JP14919 60 YR Male JPN Preferred Term Product Role Route Dosage Text Duration Manufacturer Pulmonary oedema NEORAL S ORAL 50 mg/d 1144 DAY NOVARTIS Lung disorder PREDNISOLONE S UNKNOWN 5 mg/d 1144 DAY Systemic inflammatory response syndrome CORTICOTROPIN S INTRAVENOUS 10 mg/d Pneumonia MIZORIBINE C ORAL 100 mg/d Hypoxia MIZORIBINE C ORAL 100 mg/d 1144 DAY Blood creatinine increased Blood urea increased Breath sounds abnormal Cardiomegaly C-reactive protein increased Dyspnoea Haemodialysis Life support Nasopharyngitis Orthopnoea Pyrexia Renal impairment Urine output decreased White blood cell count increased Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 8 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 5781499 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Apr-2005 5781499 EXPEDITED (15-DAY) Y HO 05P-163-0296286-00 4 YR Male USA Preferred Term Product Role Route Sepsis DEPAKENE S Hypertension CORTICOTROPIN S Dosage Text Duration Manufacturer Blood pressure immeasurable Candida infection Pancreas infection Pancreatitis haemorrhagic Pseudocyst Pulmonary oedema FDA Received Date 5774971 Case # Case Type Health Professional 25-Apr-2005 5774971 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO PHBS2005JP04886 50 YR Female JPN Preferred Term Product Role Route Pneumonia cryptococcal CICLOSPORIN S UNKNOWN Pyrexia CORTICOTROPIN S UNKNOWN Dosage Text Duration Manufacturer NOVARTIS Blood beta-D-glucan increased Fungal test positive Inflammation Lung infiltration Pneumomediastinum Respiratory disorder Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 9 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 5826381 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Jun-2005 5826381 EXPEDITED (15-DAY) N HO 138768USA 42 YR Female USA Preferred Term Product Role Route Insomnia COPAXONE S Nervousness ACTHAR GEL-SYNTHETIC S Irritability WELLBUTRIN C Depression TRILEPTAL C Suicidal ideation ZANAFLEX C Steroid withdrawal syndrome PROVIGIL C Multiple sclerosis SYNTHROID C Condition aggravated ATENOLOL C REMERON C TRAZODONE HYDROCHLORIDE C FDA Received Date 5966070 Case # Case Type Health Professional Outcomes 18-Jan-2006 5966070 DIRECT Y DS Dosage Text Manufacturer Control # Duration Age Manufacturer Sex Country 152 DAY Male Preferred Term Product Role Route Dosage Text Hypertrophic cardiomyopathy CORTICOTROPIN S 50 UNITS DAILY IM INTRAMUSCULAR Duration USA Manufacturer Hypertension FDA Received Date 6097761 Case # Case Type Health Professional Outcomes 19-Jul-2006 6097761 DIRECT Y HO Manufacturer Control # Preferred Term Product Role Route Dosage Text Pyrexia RITUXIMAB S INTRAVENOUS 375 MG/M2 IV X 4 Vomiting CORTICOTROPIN S INTRAMUSCULAR 0.12 CC IM QOD Age Sex Country 2 YR Female USA Duration Manufacturer Drug intolerance Escherichia urinary tract infection Hypophagia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 10 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6116280 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Aug-2006 6116280 EXPEDITED (15-DAY) Y HO ADE-SU-0013-ACT 32 YR Female USA Preferred Term Product Role Route Dosage Text Headache H.P. ACTHAR S 80 IU IM QD WITH TAPER Hypertension AVONEX C LEXAPRO C ATIVAN C ZANAFLEX C LYRICA C LABETALOL HCL C VESICARE C METHOTREXATE C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 11 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6090243 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Aug-2006 6090243 EXPEDITED (15-DAY) Y DE,HO,OT PHBS2006JP10464 20 YR Male JPN Preferred Term Product Role Route Dosage Text Staphylococcal infection NEORAL S ORAL 150 mg/d Multi-organ failure CORTICOTROPIN S ORAL 20 mg/d Sepsis PENTASA C Duration Manufacturer NOVARTIS 20 mg/d Anaemia Back pain Blood pressure decreased Chest pain Coagulation time prolonged Depressed level of consciousness Epistaxis Haematochezia Hepatic enzyme increased Hepatic failure Hepatic function abnormal Hepatocellular injury Herpes zoster Melaena Oliguria Platelet count decreased Shock FDA Received Date 6139409 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 14-Sep-2006 6139409 EXPEDITED (15-DAY) Y HO 06-ADE-SU-0017-ACT 213 DAY Female Preferred Term Product Role Route Dosage Text Duration Herpes simplex meningoencephalitis CORTICOTROPIN S 150 U/M2 PER DAY IM 10 DAY Disease recurrence COPAXONE C Date - Time: 05-05-2014 8:35:59 AM EST INTRAMUSCULAR Note: If the field is blank, there is no data Sex Country USA Manufacturer Page: 12 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6152650 Case # Case Type Health Professional Outcomes 13-Oct-2006 6152650 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Vomiting ACTH S 80 UNITS/ML DAILY Age Sex Country 1 YR Male USA Duration Manufacturer FDA Received Date 6233490 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Jan-2007 6233490 EXPEDITED (15-DAY) N HO 06-ADE-SU-0029-ACT 41 YR Female USA Preferred Term Product Role Route Dosage Text Myalgia H.P. ACTHAR S 80 U IM QD Muscle spasms AVONEX C INTRAMUSCULAR Duration Manufacturer Body temperature increased Drug effect decreased Drug ineffective Injection site cellulitis Injection site reaction Localised infection Nuclear magnetic resonance imaging abnormal White blood cell count increased FDA Received Date 6324100 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 27-Jun-2007 6324100 EXPEDITED (15-DAY) Y OT PHBS2007IT08693 19 YR Male ITA Preferred Term Product Role Route Hypokalaemia OXCARBAZEPINE S Hyperglycaemia ACTH S Glycosuria PRIMIDONE S Fluid retention VALPROATE SODIUM S Dosage Text Duration Manufacturer NOVARTIS 0.01 mg/kg/day Drug ineffective Drug interaction Drug level decreased Epilepsy Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 13 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6378493 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jul-2007 6378493 NON-EXPEDITED Y HO QST_00027_2007 51 YR Female USA Preferred Term Product Role Route Dosage Text Cardiac failure congestive H.P. ACTHAR S (1 DF QD INTRAMUSCULAR) LISINOPRIL C INTRAMUSCULAR Duration Manufacturer FDA Received Date 6378494 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jul-2007 6378494 NON-EXPEDITED N OT QST_00014_2007 38 YR Female USA Preferred Term Product Role Route Dosage Text Oral candidiasis H.P. ACTHAR S (80 IU QD X1 WEEK, FOLLOWED BY TAPER SUBCUTANEOUS) AVONEX C BACLOFEN C NEURONTIN C VESICARE C ZANAFLEX C KLONOPIN C HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE C FDA Received Date 6426551 Case # Case Type Health Professional 13-Sep-2007 6426551 EXPEDITED (15-DAY) SUBCUTANEOUS Duration Manufacturer Outcomes Manufacturer Control # Age HO 07-ADE-SU-0012-ACT 109 DAY Female Preferred Term Product Role Route Dosage Text Irritability H.P. ACTHAR S 40U IM QD Cold sweat VIGABATRIN C INTRAMUSCULAR Duration Sex Country USA Manufacturer Complex partial seizures Condition aggravated Convulsion Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 14 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6579397 Case # Case Type Health Professional Outcomes Manufacturer Control # 27-Feb-2008 6579397 EXPEDITED (15-DAY) Y HO CIP08000267 Preferred Term Product Role Route Dosage Text Purulence RISEDRONATE SODIUM S 17.5 MG, 1/WEEK, ORAL Pulpitis dental CORTICOTROPIN S ELCITONIN (ELCATONIN) C ORAL Age Sex Country Female JPN Duration Manufacturer FDA Received Date 6617712 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 07-Apr-2008 6617712 EXPEDITED (15-DAY) N HO 08-ADE-SU-0003-ACT 334 DAY Male Preferred Term Product Role Route Dosage Text Acne ACTHAR S 40 IU IM QD WITH TAPER Fluid retention CLONAZEPAM 0.2 MG C Weight increased VITAMIN B C Duration Sex Country USA Manufacturer Chromaturia Decreased appetite Dehydration Diet refusal Hypophagia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 15 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6618820 Case # Case Type Health Professional 18-Apr-2008 6618820 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country OT US-PFIZER INC-2008032792 39 YR Male USA Preferred Term Product Role Route Phaeochromocytoma HYDROCORTISONE SODIUM SUCCINATE S PARENTERAL Myocardial ischaemia PREDNISONE S ORAL Cardiac failure congestive ACTH S Dosage Text Duration Manufacturer Aspartate aminotransferase increased Hypertension Hyperthermia Pulmonary oedema FDA Received Date 6729230 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Jun-2008 6729230 NON-EXPEDITED N HO 08-ADE-SE-0002-ACT 65 YR Male USA Preferred Term Product Role Route Dosage Text Wheezing H.P. ACTHAR S 40 U TWICE WEEKLY Duration Manufacturer Multiple sclerosis relapse Pneumonia FDA Received Date 6697029 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Jul-2008 6697029 EXPEDITED (15-DAY) Y LT USWATSON-2008-03941 39 YR Male USA Preferred Term Product Role Route Dosage Text Phaeochromocytoma HYDROCORTISONE ACETATE S PARENTERAL UNK WATSON PREDNISONE S ORAL UNK WATSON ACTH S PARENTERAL UNK Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 16 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6719085 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 05-Aug-2008 6719085 EXPEDITED (15-DAY) Y OT US-BOEHRINGER INGELHEIM GMBH, GERMANY-2008BP-12011RO 334 DAY Unknown Preferred Term Product Role Route Hypercalcaemia PREDNISONE S ACTH S CALCIUM S REHYDRATION C Dosage Text Sex Duration Country USA Manufacturer BOEHRINGER INGELHEIM FDA Received Date 6738271 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex 27-Aug-2008 6738271 EXPEDITED (15-DAY) Y HO USWATSON-2008-05026 334 DAY Unknown USA Preferred Term Product Role Route Dosage Text Hypercalcaemia PREDNISONE S UNKNOWN 12 mg, bid with 4 week taper WATSON Withdrawal syndrome PREDNISONE S UNKNOWN 3 mg, bid WATSON ACTH S UNKNOWN UNK FDA Received Date 6753599 Case # Case Type Health Professional Outcomes Manufacturer Control # 29-Aug-2008 6753599 EXPEDITED (15-DAY) Y HO 2007-01039FE Preferred Term Product Role Route Dosage Text Pituitary haemorrhage CORTICOTROPIN S INTRAVENOUS 20 MCG ONCE Headache GONADORELIN S INTRAVENOUS 20 MCG ONCE Nausea GONADORELIN S INTRAVENOUS 20 MCG ONCE Chest discomfort THYROTROPIN S INTRAVENOUS 100 MCG ONCE Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Country Age Duration Manufacturer Sex Country Unknown JPN Manufacturer Page: 17 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6754753 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Aug-2008 6754753 EXPEDITED (15-DAY) Y HO 2007-01098FE 67 YR Female JPN Preferred Term Product Role Route Pituitary haemorrhage GONADORELIN S Dosage Text Duration 1 DAY Headache CORTICOTROPIN\SERACTIDE ACETATE S 1 DAY Manufacturer Haematoma Neoplasm progression Nerve compression Nuclear magnetic resonance imaging abnormal Visual impairment Vomiting FDA Received Date 6758690 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Aug-2008 6758690 EXPEDITED (15-DAY) Y HO,OT 2007-01070FE 49 YR Male DEU Preferred Term Product Role Route Dosage Text Blindness PROTIRELIN S INTRAVENOUS 0.2 MG ONCE IV Headache GONADORELIN S INTRAVENOUS 0.1 MG ONCE IV Nausea ACTH S INTRAVENOUS 0.25 MG ONCE IV Duration Manufacturer Vision blurred FDA Received Date 6745808 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Oct-2008 6745808 EXPEDITED (15-DAY) Y OT JP-GENENTECH-267008 72 YR Female JPN Preferred Term Product Role Route VIIth nerve paralysis RITUXAN S CYCLOPHOSPHAMIDE S ADRIAMYCIN S PREDNISOLONE S CORTICOTROPIN S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Manufacturer GENENTECH Page: 18 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 6994519 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 07-May-2009 6994519 EXPEDITED (15-DAY) Y DE 09-ADE-SU-0013-ACT 136 DAY Male Preferred Term Product Role Route Dosage Text Bronchiolitis ACTH S ACTH 20-40 U IM QD Acute respiratory distress syndrome PHENOBARBITAL C Tonic convulsion CEFACLOR C INTRAMUSCULAR Sex Duration Country USA Manufacturer Diarrhoea Infantile spasms Irritability Oral candidiasis Pneumonia Pulmonary oedema Respiratory failure Respiratory syncytial virus test positive FDA Received Date 8584439 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-May-2009 8584439 EXPEDITED (15-DAY) Y OT 09-ADE-SU-0011-ACT 7 YR Female USA Preferred Term Product Role Route Leukaemia H.P. ACTHAR S FDA Received Date 7171596 Case # Case Type Health Professional 26-Oct-2009 7171596 EXPEDITED (15-DAY) Dosage Text Manufacturer Outcomes Manufacturer Control # Age DE 09-ADE-SU-0027-ACT 136 DAY Male Preferred Term Product Role Route Dosage Text Pneumonia aspiration H.P. ACTHAR S 40 IU/DAY WITH TAPER Somnolence PHENOBARBITAL C Irritability LANSOPRAZOLE C METOCLOPRAMIDE C GLYCOPYRROLATE C Date - Time: 05-05-2014 8:35:59 AM EST Duration Note: If the field is blank, there is no data Duration Sex Country USA Manufacturer Page: 19 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7225795 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Dec-2009 7225795 EXPEDITED (15-DAY) Y HO 09-ADE-SU-0032-ACT 70 YR Male USA Preferred Term Product Role Route Dosage Text Duration Urine output decreased H.P. ACTHAR S 80 U SC X 5 D THEN TAPER 10 DAY Manufacturer Cardiac failure congestive Dyspnoea Oedema peripheral Urinary tract infection FDA Received Date 7228400 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 07-Dec-2009 7228400 EXPEDITED (15-DAY) N HO 09-ADE-SU-0034-ACT 243 DAY Male Preferred Term Product Role Route Dosage Text Respiratory tract infection H.P. ACTHAR S 80 U SC BID - 6 WK TAPER Hypertension PHENOBARBITAL C SUBCUTANEOUS Sex Duration Country USA Manufacturer Decreased appetite Diet refusal Weight increased FDA Received Date 7229292 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 07-Dec-2009 7229292 EXPEDITED (15-DAY) N HO 09-ADE-SU-0033-ACT 243 DAY Male Preferred Term Product Role Route Dosage Text Weight increased H.P. ACTHAR S 80 U SC BIS - 6 WK TAPER Decreased appetite PHENOBARBITAL C Duration Sex Country USA Manufacturer Diet refusal Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 20 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7229057 Case # Case Type Health Professional Outcomes 21-Dec-2009 7229057 DIRECT Y DE,HO,LT,OT Manufacturer Control # Age Sex Country 2 YR Male USA Preferred Term Product Role Route Dosage Text Septic shock RITUXIMAB S INTRAVENOUS DRIP 750 MG/M2 2X, 2 WKS APART IV DRIP Duration Manufacturer GENENTECH Multi-organ failure ACTHAR GEL-SYNTHETIC S INTRAMUSCULAR 25 IU/M2 QOD IM QUESTCOR Aplastic anaemia CLONIDINE C Hydrocephalus AMLODIPINE C Cerebral haemorrhage CALCIUM CARBONATE C Convulsion CAPTOPRIL C Renal failure acute NIFEDIPINE C Acute respiratory distress syndrome HUMAN IMMUNOGLOBULIN G C Hypertension BACTRIM C Sepsis PENTAMIDINE C FDA Received Date 8584444 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Mar-2010 8584444 EXPEDITED (15-DAY) N HO 09-ADE-NU-0006-ACT 4 YR Male USA Preferred Term Product Role Route Dosage Text Cushing's syndrome H.P. ACTHAR S 0.28 ML QOD IM Adrenomegaly HUMAN IMMUNOGLOBULIN G C BACTRIM C PREVACID C RITUXIMAB C INTRAMUSCULAR FDA Received Date 7344588 Case # Case Type Health Professional Outcomes Manufacturer Control # 05-Apr-2010 7344588 EXPEDITED (15-DAY) Y OT JP-PFIZER INC-2010042681 Preferred Term Product Role Route Stereotypy METHYLPREDNISOLONE S CORTICOTROPIN S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Age Duration Manufacturer Sex Country Male JPN Manufacturer PFIZER Page: 21 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7361103 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 07-Apr-2010 7361103 EXPEDITED (15-DAY) N HO 233212J10USA 55 YR Female USA Preferred Term Product Role Route Blood glucose increased REBIF S Blood potassium abnormal CORTICOTROPIN S Dosage Text Duration Manufacturer FDA Received Date 7407829 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 27-May-2010 7407829 EXPEDITED (15-DAY) Y HO 10-ADE-SU-0020-ACT 70 YR Female USA Preferred Term Product Role Route Dosage Text Dizziness H.P. ACTHAR S 80 IU SC QD X 5 DAYS Nausea REBIF C Fall ASA C SUBCUTANEOUS Duration Manufacturer Treatment noncompliance FDA Received Date 7423952 Case # Case Type Health Professional Outcomes Manufacturer Control # 11-Jun-2010 7423952 EXPEDITED (15-DAY) Y DE 10-ADE-SU-0024-ACT Preferred Term Product Role Route Neonatal infection H.P. ACTHAR S Dosage Text Age Sex Country Unknown USA Duration Manufacturer 6 YR FDA Received Date 7424176 Case # Case Type Health Professional Outcomes Manufacturer Control # 11-Jun-2010 7424176 EXPEDITED (15-DAY) Y DE 10-ADE-SU-0025-ACT Preferred Term Product Role Route Dosage Text Infection H.P. ACTHAR S 10 YEARS AGO Age Sex Country Unknown USA Duration Manufacturer FDA Received Date 7537469 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 01-Jul-2010 7537469 NON-EXPEDITED Y HO 09-ADE-SE-0040-ACT 75 YR Male USA Preferred Term Product Role Route Dosage Text Cardiac failure congestive H.P. ACTHAR S 40 IU IM Q3D Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 22 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7537521 Case # Case Type Health Professional Outcomes Manufacturer Control # 01-Jul-2010 7537521 NON-EXPEDITED Y HO 09-ADE-SE-0019-ACT Preferred Term Product Role Route Herpes zoster H.P. ACTHAR S KLONOPIN C ZONISAMIDE C PREDNISONE C VITAMIN B6 C MELATONIN C VIGABATRIN C Dosage Text Age Sex Country Female USA Duration Manufacturer FDA Received Date 7537524 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 01-Jul-2010 7537524 NON-EXPEDITED N HO 09-ADE-SE-0017-ACT 213 DAY Male Preferred Term Product Role Route Dosage Text Hypertension H.P. ACTHAR S .53 ML IM BID WITH TAPER Glaucoma SEPTRA - TIW C Oedema peripheral VIGABATRIN C Sex Duration Country USA Manufacturer FDA Received Date 7537534 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 01-Jul-2010 7537534 NON-EXPEDITED N HO 09-ADE-SE-0015-ACT 3 YR Male USA Preferred Term Product Role Route Dosage Text Hypertension H.P. ACTHAR S 40 IU IM BID WITH TAPER Duration Manufacturer Kyphosis Muscular weakness Osteoporosis Spinal compression fracture Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 23 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7503051 Case # Case Type Health Professional Outcomes 22-Jul-2010 7503051 DIRECT Y HO,OT Manufacturer Control # Age Sex Country 255 DAY Male Preferred Term Product Role Route Dosage Text Hypertension CORTICOTROPIN S 32 UNITS IM INTRAMUSCULAR Duration USA Manufacturer FDA Received Date 7547161 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Aug-2010 7547161 EXPEDITED (15-DAY) Y OT DEJNJFOC-20100805590 3 YR Female DEU Preferred Term Product Role Route Drug resistance TOPAMAX S UNKNOWN VALPROIC ACID S UNKNOWN CLOBAZAM S UNKNOWN PYRIDOXINE HYDROCHLORIDE S UNKNOWN SULTHIAME S UNKNOWN PHENOBARBITAL S UNKNOWN CORTICOTROPIN S UNKNOWN VIGABATRIN S UNKNOWN LEVETIRACETAM S UNKNOWN Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Manufacturer Page: 24 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7369418 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Oct-2010 7369418 EXPEDITED (15-DAY) Y HO PHHY2010JP24881 13 YR Female JPN Preferred Term Product Role Route Dosage Text Duration Manufacturer Tracheostomy malfunction NEORAL S ORAL 80 mg daily 1 DAY NOVARTIS Lung operation NEORAL S ORAL 700 mg daily 16 DAY NOVARTIS Bronchostenosis NEORAL S ORAL 300 mg daily 17 DAY NOVARTIS Laser therapy NEORAL S ORAL 280 mg daily 39 DAY NOVARTIS Tracheostomy NEORAL S ORAL 200 mg daily 28 DAY NOVARTIS Pulmonary artery therapeutic procedure NEORAL S ORAL 300 mg daily SANDIMMUNE S INTRAVENOUS 12 mg daily 3 DAY SANDIMMUNE S INTRAVENOUS 24 mg daily 2 DAY SANDIMMUNE S INTRAVENOUS 60 mg daily 15 DAY CORTICOTROPIN S INTRAVENOUS 1000 mg daily 1 DAY CORTICOTROPIN S INTRAVENOUS 250 mg daily 1 DAY CORTICOTROPIN S INTRAVENOUS 40 mg daily 2 DAY CORTICOTROPIN S INTRAVENOUS 20 mg daily 18 DAY CORTICOTROPIN S ORAL 12.5 mg daily 89 DAY CORTICOTROPIN S ORAL 10 mg daily 22 DAY CORTICOTROPIN S ORAL 7.5 mg daily 203 DAY CORTICOTROPIN S ORAL 6.25 mg daily MYCOPHENOLATE MOFETIL S ORAL 250 mg daily 1 DAY MYCOPHENOLATE MOFETIL S ORAL 500 mg daily 250 DAY MYCOPHENOLATE MOFETIL S ORAL 750 mg daily NOVARTIS FDA Received Date 7599471 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 28-Oct-2010 7599471 EXPEDITED (15-DAY) Y DE 10-ADE-SU-0045-ACT 1 YR Male USA Preferred Term Product Role Route Dosage Text Pneumonia H.P. ACTHAR S 80 IU IM WITH TAPER Respiratory distress CLOBAZAM C VIGABATRIN C Date - Time: 05-05-2014 8:35:59 AM EST INTRAMUSCULAR Note: If the field is blank, there is no data Duration Manufacturer Page: 25 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7778562 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 06-Jan-2011 7778562 EXPEDITED (15-DAY) Y HO 10-ADE-SU-0068-ACT 35 YR Female USA Preferred Term Product Role Route Dosage Text Grand mal convulsion H.P. ACTHAR S 80 IU SC DAILY X 5 DAYS White blood cell count decreased REBIF C Blood potassium decreased KLONOPIN C Blood sodium increased PROMETHAZINE C Hypertension PROZAC C Adrenal disorder ZOCOR C BACLOFEN C ZANAFLEX C COUMADIN C AGRYLIN C FDA Received Date 8584445 Case # Case Type Health Professional Outcomes 06-Jan-2011 8584445 DIRECT Y OT Manufacturer Control # Duration Age Manufacturer Sex Country 237 DAY Male Preferred Term Product Role Route Dosage Text No therapeutic response H.P. ACTHAR S 0.6ML QAM IM INTRAMUSCULAR Duration USA Manufacturer QUESTCOR Developmental delay Product counterfeit FDA Received Date 7795613 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Feb-2011 7795613 EXPEDITED (15-DAY) Y HO,OT USBAYER-200810735NA 43 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Multiple sclerosis relapse INTERFERON BETA-1B S 8 miu, QOD 29 DAY BAYER Muscular weakness INTERFERON BETA-1B S UNK 100 DAY BAYER Pain in extremity INTERFERON BETA-1B S UNK 386 DAY BAYER Dizziness INTERFERON BETA-1B S SUBCUTANEOUS 2 miu, QOD 561 DAY BAYER Headache INTERFERON BETA-1B S SUBCUTANEOUS 8 miu, QOD 9 DAY BAYER Angiopathy INTERFERON BETA-1B S SUBCUTANEOUS 8 miu, QOD 3 DAY BAYER Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Page: 26 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7795613 Preferred Term Product Role Route Dosage Text Nervous system disorder INTERFERON BETA-1B S 6 miu, QOD Contusion ACTHAR S Intervertebral disc degeneration ACTHAR S Neck pain FAMOTIDINE C Blindness unilateral PREDNISONE C Central nervous system inflammation UNCODEABLE "UNCLASSIFIABLE" C Photophobia PERCOCET C Duration Manufacturer BAYER TAPERING TO 40 MG Abdominal discomfort Abdominal pain upper Abnormal sensation in eye Aphagia Back pain Balance disorder Blood pressure decreased Central nervous system lesion Cerebrovascular arteriovenous malformation Dyspepsia Erythema Eye pain Eye swelling Fall Flushing Gastrooesophageal reflux disease Haematemesis Headache Head discomfort Heart rate decreased Malaise Nausea Optic nerve injury Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 27 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7795613 Preferred Term Product Role Route Dosage Text Duration Manufacturer Oropharyngeal pain Oxygen saturation decreased Pharyngeal oedema Pupils unequal Skin injury Stress Visual acuity reduced Vomiting Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 28 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7794864 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Feb-2011 7794864 EXPEDITED (15-DAY) Y DE,HO,OT PHHY2011JP06959 70 YR Female JPN Preferred Term Product Role Route Dosage Text Hepatitis E SANDIMMUNE S INTRAVENOUS UNK Hepatitis fulminant CORTICOTROPIN S INTRAVENOUS Hepatic atrophy STEROIDS NOS C Duration Manufacturer NOVARTIS Adrenalitis Alanine aminotransferase increased Aspartate aminotransferase increased Blood bilirubin increased Cholestasis Condition aggravated Cytomegalovirus infection Eosinophilic pneumonia Haemorrhage Hepatic fibrosis Hepatic function abnormal Hepatic necrosis Jaundice Pancreatitis necrotising Pneumonia Prothrombin time prolonged FDA Received Date 7890138 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Mar-2011 7890138 EXPEDITED (15-DAY) Y HO 11-ADE-SU-0020-ACT 1 YR Male USA Preferred Term Product Role Route Dosage Text Hyperthermia malignant H.P. ACTHAR S 30 IU IM BID WITH TAPER ALBUTEROL C VALPROIC ACID C ZANTAC C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 29 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7932776 Case # Case Type Health Professional Outcomes 25-Apr-2011 7932776 DIRECT Y OT Manufacturer Control # Age Sex Country 32 DAY Female Preferred Term Product Role Route Dosage Text Mobility decreased ACTHAR S 80 U DAILY SC SUBCUTANEOUS Duration USA Manufacturer QUESTCOR Abasia Diplopia Dysgeusia Impaired driving ability Thinking abnormal Vision blurred FDA Received Date 7575889 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 26-Apr-2011 7575889 EXPEDITED (15-DAY) Y HO,LT,OT PHHY2010JP56543 22 YR Female JPN Preferred Term Product Role Route Dosage Text Duration Manufacturer Lymphoma CICLOSPORIN S 80 mg, BID 33 DAY NOVARTIS Tongue neoplasm malignant stage unspecified CICLOSPORIN S 80 mg 35 DAY NOVARTIS Malnutrition CICLOSPORIN S 50 mg 413 DAY NOVARTIS Urine ketone body present CICLOSPORIN S UNK Respiratory failure NEORAL S ORAL UNK 17 DAY Dyspnoea SANDIMMUNE S INTRAVENOUS DRIP UNK 12 DAY Vital capacity decreased MYCOPHENOLATE MOFETIL S ORAL 250 mg, UNK 1 DAY Hypophagia MYCOPHENOLATE MOFETIL S ORAL 500 mg, UNK 8 DAY Tachycardia MYCOPHENOLATE MOFETIL S ORAL 750 mg, UNK 40 DAY Blood pressure decreased MYCOPHENOLATE MOFETIL S ORAL 500 mg, UNK 125 DAY Blood creatinine increased MYCOPHENOLATE MOFETIL S ORAL 750 mg, UNK Hypoglycaemia METHYLPREDNISOLONE S INTRAVENOUS 100 mg, UNK 9 DAY Gastroenteritis METHYLPREDNISOLONE S INTRAVENOUS 50 mg, UNK 6 DAY Diarrhoea PREDNISOLONE S ORAL 15 mg, UNK White blood cell count increased PREDNISOLONE S ORAL 12.5 mg, UNK Metabolic acidosis PREDNISOLONE S ORAL 10 mg, UNK Dehydration PREDNISOLONE S ORAL 7.5 mg, UNK Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data NOVARTIS Page: 30 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7575889 Preferred Term Product Role Route Dosage Text Enterocolitis PREDNISOLONE S ORAL 6.75 mg, UNK Nausea PREDNISOLONE S ORAL 5 mg, UNK PREDNISOLONE S ORAL 3.75 mg, UNK PREDNISOLONE S ORAL 5 mg, UNK CORTICOTROPIN S INTRAVENOUS 1500 mg, UNK HYDROCORTISONE SODIUM SUCCINATE C INTRAVENOUS 100 mg METILDIGOXIN C 0.1 mg/day ETIZOLAM C 1 mg/day SULFAMETHOXAZOLE AND TRIMETHOPRIM C 1 g/day AMPHOTERICIN B C 1.2 g/day ACYCLOVIR C 200 mg/day LANSOPRAZOLE C 60 mg/day ATROPINE SULFATE C 0.3 mg PETHIDINE HYDROCHLORIDE C MIDAZOLAM C 2 mg PROPOFOL C 40 mg REMIFENTANIL C 0.25 ug/kg/min SEVOFLURANE C 03 percent ROCURONIUM BROMIDE C CEFAZOLIN SODIUM C INTRAVENOUS 600 mg VALGANCICLOVIR C ORAL 450 mg, UNK INTRAMUSCULAR Duration Manufacturer 30 mg 20 mg 29 DAY FDA Received Date 8034315 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Jun-2011 8034315 NON-EXPEDITED Y HO 10-ADE-SE-0056-ACT 55 YR Female USA Preferred Term Product Role Route Oedema H.P. ACTHAR S Dosage Text Duration Manufacturer Fluid retention Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 31 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8034320 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Jun-2011 8034320 NON-EXPEDITED Y HO 10-ADE-SE-0027-ACT 45 YR Female USA Preferred Term Product Role Route Dosage Text Multiple sclerosis relapse H.P. ACTHAR S 80 IU SC DAILY X 5 DAYS Hypokalaemia PROVIGIL C Oedema peripheral SYNTHROID C LASIX C HYOSCYAMINE C PROTONIX C SIMVASTATIN C PRISTIQ EXTENDED RELEASE C XANAX C SUBCUTANEOUS Duration Manufacturer FDA Received Date 7399061 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 30-Jun-2011 7399061 EXPEDITED (15-DAY) Y HO 10-ADE-SU-0016-ACT 213 DAY Female Preferred Term Product Role Route Dosage Text Cardiomyopathy H.P. ACTHAR S 30IU IM Q12H Pneumothorax TOPAMAX C Pneumocystis jirovecii pneumonia ZONEGRAN C Pneumonia streptococcal VIGABATRIN C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Sex Country USA Manufacturer Page: 32 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7743925 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 30-Jun-2011 7743925 EXPEDITED (15-DAY) Y DE 10-ADE-SU-0065-ACT 2 YR Male USA Preferred Term Product Role Route Dosage Text Sepsis H.P. ACTHAR S 34 IU IM BID TO QOD Pancytopenia RITUXAN C Hypotension HYDROCORTISONE C Duration Manufacturer Bone marrow failure Cardiac output decreased Drug ineffective Haemorrhage intracranial FDA Received Date 8019627 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Jul-2011 8019627 EXPEDITED (15-DAY) Y OT PHHY2009JP45379 20 YR Female JPN Preferred Term Product Role Route Dosage Text Cytomegalovirus infection SIMULECT S 20 mg, UNK Transplant rejection TACROLIMUS S ORAL UNK Pneumocystis jirovecii pneumonia CORTICOTROPIN S ORAL UNK METHYLPREDNISOLONE S MYCOPHENOLATE MOFETIL S RITUXIMAB C Date - Time: 05-05-2014 8:35:59 AM EST Duration Manufacturer NOVARTIS UNK ORAL UNK Note: If the field is blank, there is no data Page: 33 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8085942 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Aug-2011 8085942 EXPEDITED (15-DAY) Y HO,LT 2011MA009088 1 YR Male JPN Preferred Term Product Role Route Dosage Text Toxicity to various agents PHENOBARBITAL S 30 MG/KG;QD;RTL Drug ineffective VITAMIN B6 S Salivary hypersecretion HUMAN IMMUNOGLOBULIN G S Obstructive airways disorder ADRENOCORTICOTROPIC HORMONE S UNSPECIFIED INGREDIENT S CLOBAZAM C VALPROIC ACID C ZONISAMIDE C RECTAL FDA Received Date 8744220 Case # Case Type Health Professional Outcomes 24-Aug-2011 8744220 DIRECT Y HO Manufacturer Control # Duration Age Manufacturer Sex Country 168 DAY Female Preferred Term Product Role Route Dosage Text Dyskinesia CORTICOTROPIN S 45 UNITS DAILY INTRAMUSCULAR Duration USA Manufacturer Bacterial translocation Diarrhoea Enteritis Hypertension Hypokalaemia Infantile spasms Occult blood positive Pneumatosis intestinalis Pyrexia Respiratory tract infection viral Sleep disorder Viral infection Vomiting Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 34 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8108297 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Sep-2011 8108297 EXPEDITED (15-DAY) Y HO 11-ADE-SU-0076-ACT 66 YR Female USA Preferred Term Product Role Route Dosage Text Hypoaesthesia H.P. ACTHAR S 80 IU SC DAILY X 5 DAYS Vertigo COPAXONE C Asthenia AMPYRA C Thrombocytopenia CADUET C PROTONIX C MYSOLINE C NUVIGIL C MICARDIS C NEXIUM C CALCIUM CARBONATE C CENTRUM SILVER C Duration Manufacturer FDA Received Date 8165403 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 20-Sep-2011 8165403 EXPEDITED (15-DAY) N HO 11-ADE-SU-0092-ACT 63 YR Male USA Preferred Term Product Role Route Dosage Text Tremor H.P. ACTHAR S 80 IU IM DAILY X 5 DAYS Dizziness TYSABRI C Altered state of consciousness KEPPRA C Loss of consciousness BACLOFEN C Staphylococcal infection PROVIGIL C ZOLOFT C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 35 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8256767 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Nov-2011 8256767 EXPEDITED (15-DAY) N OT US-US-EMD SERONO, INC.-233212J10USA 55 YR Female USA Preferred Term Product Role Route Blood glucose increased REBIF S Blood potassium abnormal ACTHAR GEL-SYNTHETIC S Dosage Text Duration Manufacturer Multiple sclerosis relapse FDA Received Date 8584446 Case # Case Type Health Professional Outcomes 02-Dec-2011 8584446 DIRECT Y HO Manufacturer Control # Age Sex Country 53 YR Female USA Preferred Term Product Role Route Dosage Text Duration Eyelid oedema H.P. ACTHAR S 1 CC @ PER DAY FOR 5 DAYS 1 DAY Manufacturer Body temperature decreased Face oedema Oedema peripheral Oropharyngeal pain FDA Received Date 8329443 Case # Case Type Health Professional 05-Jan-2012 8329443 DIRECT Y Outcomes Manufacturer Control # Preferred Term Product Role Route Dosage Text Dyspnoea ACTHAR S 80UNITS DAILY X 5 DAYS SQ SUBCUTANEOUS Age Sex Country 48 YR Female USA Duration Manufacturer QUESTCOR Generalised oedema FDA Received Date 8355570 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 13-Jan-2012 8355570 EXPEDITED (15-DAY) N HO DKLU1075795 213 DAY Male Preferred Term Product Role Route Dosage Text Gastrooesophageal reflux disease SABRIL S 1000 MG MILLIGRAM (S), 2 IN 1 D, ORAL ACTH S Date - Time: 05-05-2014 8:35:59 AM EST ORAL Note: If the field is blank, there is no data Duration Sex Country USA Manufacturer Page: 36 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8391075 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 23-Jan-2012 8391075 EXPEDITED (15-DAY) N HO 12-ADE-SU-0004-ACT 213 DAY Male Preferred Term Product Role Route Dosage Text Drug ineffective H.P. ACTHAR S 60-70 IU IM QD TAPER Vomiting VIGABATRIN C Sex Duration Country USA Manufacturer Dehydration Gastrooesophageal reflux disease FDA Received Date 8401643 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Feb-2012 8401643 EXPEDITED (15-DAY) Y DE FRASTRAZENECA-2012SE 08099 61 YR Female FRA Preferred Term Product Role Route Intestinal infarction ARIMIDEX S ORAL Hypertension INEXIUM S ORAL AVASTIN S INTRAVENOUS RIVOTRIL S ORAL ZOMETA S INTRAVENOUS NICARDIPINE HYDROCHLORIDE S UNKNOWN PRIMPERAN S ORAL LYRICA S ORAL CORTICOTROPIN S UNKNOWN DURAGESIC C ACETAMINOPHEN C LOVENOX C ORAMORPH SR SUSTAINED RELEASE C Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Manufacturer ZENECA Page: 37 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8429154 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Feb-2012 8429154 EXPEDITED (15-DAY) Y HO 12-ADE-SU-0016-ACT 80 YR Male USA Preferred Term Product Role Route Dosage Text Acute myocardial infarction H.P. ACTHAR S 80 IU IM TWICE A WEEK HYDRALAZINE C NIACIN C LIPITOR C AMLODIPINE C FUROSEMIDE C LOSARTAN POTASSIUM C INTRAMUSCULAR Duration Manufacturer FDA Received Date 8661765 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Feb-2012 8661765 EXPEDITED (15-DAY) N HO DKLU1076498 1 YR Female USA Preferred Term Product Role Route Dosage Text Dyspnoea SABRIL S ORAL SEE IMAGE Viral infection ONFI S ORAL 5 MG MILLIGRAM(S), 1 IN 1 D, ORAL Decreased appetite ACTH S Heart rate increased AMPICILLIN C Dehydration ZANTAC C Duration Manufacturer 0.43 ML MILLILITRE(S), 2 IN 1 D Irritability Vomiting Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 38 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8434121 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Feb-2012 8434121 EXPEDITED (15-DAY) Y HO 12-ADE-SU-0019-ACT 64 YR Male USA Preferred Term Product Role Route Dosage Text Acute abdomen H.P. ACTHAR S 80 IU IM TWICE A WEEK Diarrhoea ROCALTROL C Diverticular perforation METOLAZONE C Renal failure acute LASIX C Refusal of treatment by patient MINOXIDIL C ZOCOR C LISINOPRIL C TUMS C CITALOPRAM C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 39 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8455437 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Mar-2012 8455437 EXPEDITED (15-DAY) Y HO QSC-2012-0006 39 YR Male USA Preferred Term Product Role Route Dosage Text Tremor H.P. ACTHAR S 1 ML QD, SUBCUTANEOUS Tongue biting INSULIN NPH (INSULIN ISOPHANE PORCINE) C Faecal incontinence NEXIUM (ESOMEPRAZOLE MAGNESIUM) C Postictal state LISINOPRIL (LISINOPRIL) C Sinus tachycardia SIMVASTATIN C SUBCUTANEOUS Duration Manufacturer Cardiac failure congestive Confusional state Diabetic nephropathy Fall Feeling abnormal Grand mal convulsion Hyperglycaemia Hypertensive emergency Mitral valve incompetence Proteinuria Pulmonary valve incompetence Renal failure acute Tricuspid valve incompetence Urinary incontinence Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 40 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8468093 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Mar-2012 8468093 EXPEDITED (15-DAY) N HO QSC-2012-0011 58 YR Female USA Preferred Term Product Role Route Dosage Text Dysarthria H.P. ACTHAR S UNK Duration Manufacturer Condition aggravated Fall Gait disturbance Multiple sclerosis Paralysis Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 41 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8495162 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 28-Mar-2012 8495162 EXPEDITED (15-DAY) Y HO QSC-2012-0018 334 DAY Male Preferred Term Product Role Route Dosage Text Duration Diabetes mellitus H.P. ACTHAR S 20 IU/DIE, QD, INTRAMUSCULAR ; 20, QOD, INTRAMUSCULAR ; 20 IU, BIW, INTRAMUSCULAR 7 DAY Enteritis VALPROATE SODIUM C INTRAMUSCULAR Sex Country ITA Manufacturer Adrenal disorder Alkalosis hypokalaemic Blood cortisol increased Bronchopneumonia Convulsion Cushingoid Dehydration Electrolyte imbalance Hirsutism Hyperadrenocorticism Hypernatraemia Lymphopenia Thrombocytopenia Weight increased FDA Received Date 8486002 Case # Case Type Health Professional Outcomes Manufacturer Control # 31-Mar-2012 8486002 EXPEDITED (15-DAY) N OT PHEH2012US006819 Preferred Term Product Role Route Dosage Text Fluid retention GILENYA S UNK H.P. ACTHAR S Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Age Duration Sex Country Unknown USA Manufacturer NOVARTIS Page: 42 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8491940 Case # Case Type Health Professional Outcomes Manufacturer Control # 03-Apr-2012 8491940 EXPEDITED (15-DAY) Y OT PHHY2012IT027874 Age Sex Country Male ITA Preferred Term Product Role Route Dosage Text Growth retardation CICLOSPORIN S 4-5 mg/kg, UNK NOVARTIS Cushingoid CICLOSPORIN S 2 mg/kg, UNK NOVARTIS Posterior reversible encephalopathy syndrome PREDNISONE S Hypertension METHYLPREDNISOLONE S TACROLIMUS S 0.1 mg/kg, UNK TACROLIMUS S 0.018 mg/kg, UNK RITUXIMAB S CORTICOTROPIN S INTRAVENOUS Duration Manufacturer 20 mg/kg, for three to five times 375 mg/m2, UNK INTRAMUSCULAR 1 mg/week FDA Received Date 8491941 Case # Case Type Health Professional Outcomes Manufacturer Control # 03-Apr-2012 8491941 EXPEDITED (15-DAY) Y OT PHHY2012IT027892 Age Country Male ITA Preferred Term Product Role Route Dosage Text Cushingoid CICLOSPORIN S 4-5 mg/kg, UNK NOVARTIS Glomerular filtration rate decreased CICLOSPORIN S 2 mg/kg, UNK NOVARTIS PREDNISONE S METHYLPREDNISOLONE S MYCOPHENOLATE MOFETIL S CYCLOPHOSPHAMIDE S CORTICOTROPIN S PLASMAPHERESIS BLOOD PACK UNIT C Date - Time: 05-05-2014 8:35:59 AM EST INTRAVENOUS Duration Sex Manufacturer 20 mg/kg, for three to five times 20-30 mg/kg, UNK 2.5 mg/kg, for 8 weeks INTRAMUSCULAR 1 mg/week Note: If the field is blank, there is no data Page: 43 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8532242 Case # Case Type Health Professional Outcomes 16-Apr-2012 8532242 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Dysarthria ACTHAR S 80UN BIW SQ Muscle spasms MICARDIS S RENVELA S PRILOSEC C AMLODIPINE C CITALOPRAM C SIMVASTATIN C FDA Received Date 8584524 Case # Case Type Health Professional 11-May-2012 8584524 DIRECT Y SUBCUTANEOUS Outcomes Preferred Term Product Role Route Drug hypersensitivity H.P. ACTHAR S FDA Received Date 8568167 Case # Case Type 14-May-2012 8568167 DIRECT Health Professional Outcomes Manufacturer Control # Dosage Text Sex Country 40 YR Male USA Duration Manufacturer QUESTCOR Age Sex Country Female USA Duration Manufacturer QUESTCOR Manufacturer Control # OT Preferred Term Product Role Route Dosage Text Oedema peripheral H.P. ACTHAR S INJECTABLE QD Date - Time: 05-05-2014 8:35:59 AM EST Age Note: If the field is blank, there is no data Age Sex Country 42 YR Female USA Duration Manufacturer Page: 44 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 7233393 Case # Case Type Health Professional Outcomes Manufacturer Control # 18-May-2012 7233393 EXPEDITED (15-DAY) Y DE,HO,OT US-ROCHE-676835 Preferred Term Product Role Route Dosage Text Aplastic anaemia MABTHERA S INTRAVENOUS DRIP 750 MG/M2, Q2W Sepsis ACTH S INTRAMUSCULAR 25 IU/M2, QOD HUMAN IMMUNOGLOBULIN G C UNK CLONIDINE C 0.5 MG, TID AMLODIPINE C 3 MG, BID CALCIUM CARBONATE C 750 MG, BID CAPTOPRIL C 6.5 MG, BID CAPTOPRIL C 10 MG, QHS NIFEDIPINE C 3.5 MG, PRN BACTRIM C PENTAMIDINE C Age Sex Country Male USA Duration Manufacturer UNK FDA Received Date 8582605 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-May-2012 8582605 EXPEDITED (15-DAY) Y OT PHHY2012JP045341 80 YR Male JPN Preferred Term Product Role Route Dosage Text Vein disorder EXJADE S 125 mg, daily Oedema peripheral CORTICOTROPIN S ORAL FDA Received Date 8600032 Case # Case Type Health Professional Outcomes 29-May-2012 8600032 DIRECT Y HO Manufacturer Control # Preferred Term Product Role Route Dosage Text Blood pressure decreased ACTHAR S 80 UNITS DAILY SUBCUTANOUS SUBCUTANEOUS Duration Manufacturer NOVARTIS Age Sex Country 65 YR Male USA Duration Manufacturer QUESTCOR Heart rate decreased Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 45 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9182131 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jun-2012 9182131 NON-EXPEDITED Y HO,LT,RI QSC-2011-0093 3 YR Male USA Preferred Term Product Role Route Bacterial sepsis H.P. ACTHAR S Dosage Text Duration Manufacturer INTRAMUSCULAR QUESTCOR FDA Received Date 9182139 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 22-Jun-2012 9182139 NON-EXPEDITED Y HO,LT,RI QSC-2011-0094 213 DAY Female Preferred Term Product Role Route Bacterial sepsis H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Sex Duration Country USA Manufacturer INTRAMUSCULAR QUESTCOR FDA Received Date 9182147 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex 22-Jun-2012 9182147 NON-EXPEDITED Y HO,RI QSC-2011-0095 182 DAY Male Country USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pneumocystis jirovecii pneumonia ACTHAR S 75 iu/m2 42 DAY QUESTCOR INTRAMUSCULAR FDA Received Date 9182156 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jun-2012 9182156 NON-EXPEDITED Y HO QSC-2011-0111 1 YR Female USA Preferred Term Product Role Route Dosage Text Infection H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S BID with taper Date - Time: 05-05-2014 8:35:59 AM EST INTRAMUSCULAR Note: If the field is blank, there is no data Duration Manufacturer QUESTCOR Page: 46 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9182170 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jun-2012 9182170 NON-EXPEDITED Y OT QSC-2011-0142 44 YR Male USA Preferred Term Product Role Route Dosage Text Blood glucose increased H.P. ACTHAR GEL S 2x Polyuria TOPMAX (TOPIRAMATE) C Feeling abnormal AMITRIPTYLINE (AMITRIPTYLINE) C AMBIEN (ZOLPIDEM TARTRATE) C GABAPENTIN (GABAPENTIN) C TEGRETOL (CARBAMAZEPINE) UNKNOWN C Duration Manufacturer QUESTCOR Dehydration Thirst FDA Received Date 9182181 Case # Case Type Health Professional 22-Jun-2012 9182181 NON-EXPEDITED Outcomes Manufacturer Control # Age HO QSC-2012-0028 304 DAY Female Preferred Term Product Role Route Diarrhoea H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text INTRAMUSCULAR Duration Sex Country USA Manufacturer QUESTCOR Convulsion Cushingoid Flatulence Oral candidiasis Retching Vomiting Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 47 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9182188 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jun-2012 9182188 NON-EXPEDITED Y HO QSC-2012-0069 60 YR Female USA Preferred Term Product Role Route Blood potassium decreased H.P. ACTHAR GEL S CLONAZEPAM (CLONAZEPAM) (CLONAZEPAM) C LEXAPRO (ESCITALOPRAM HORMONE) C VITAMIN D (ERGOCALCIFEROL) C LEVOTHYROXINE (LEVOTHYROXINE) C FDA Received Date 9182193 Case # Case Type Health Professional 22-Jun-2012 9182193 NON-EXPEDITED Dosage Text Duration Manufacturer SUBCUTANEOUS QUESTCOR Outcomes Manufacturer Control # Age HO,LT QSC-2012-0078 304 DAY Female Preferred Term Product Role Route Pneumonia H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Sex Duration Country USA Manufacturer SUBCUTANEOUS QUESTCOR FDA Received Date 8665706 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Jun-2012 8665706 EXPEDITED (15-DAY) Y HO QSC-2012-0102 48 YR Female USA Preferred Term Product Role Route Dosage Text Leukocytosis H.P. ACTHAR S UNK Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 48 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8648320 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Jul-2012 8648320 EXPEDITED (15-DAY) Y OT NL-ROXANE LABORATORIES, INC.-2012-RO-01501RO 1 YR Male NLD Preferred Term Product Role Route Dehydration FUROSEMIDE S Renal failure chronic FUROSEMIDE S Renin decreased AMLODIPINE S Drug ineffective SODIUM POLYSTYRENE SULFONATE S HYDROCHLOROTHIAZIDE S HYDROCHLOROTHIAZIDE S ATENOLOL S ACTH S MISOPROSTOL S Dosage Text Manufacturer ROXANE INTRAVENOUS ROXANE ROXANE ORAL ROXANE ORAL ORAL FDA Received Date 8675279 Case # Case Type Health Professional Outcomes 11-Jul-2012 8675279 DIRECT Y HO 400 mg Manufacturer Control # Preferred Term Product Role Route Dosage Text Headache ACTHAR S ACTHAR 80 UNITS TWICE A WEEK X 6MO 057 SUB Q Hypertension AMLODIPINE C ATENOLOL C CALCIUM C FUROSEMIDE C LOVAZA C POTASSIUM C PRILOSEC C SPIRONOLACTONE C TRAMADOL HYDROCHLORIDE C VITAMIN D C Date - Time: 05-05-2014 8:35:59 AM EST Duration Note: If the field is blank, there is no data Age Sex Country 73 YR Female USA Duration Manufacturer QUESTCOR Page: 49 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8677966 Case # Case Type Health Professional Outcomes 12-Jul-2012 8677966 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Feeling cold ACTHAR S 40U TWICE WEEKLY SUBCUTANEOUS Age Sex Country 59 YR Male USA Duration Manufacturer Dizziness Joint swelling Nausea Oedema peripheral Pruritus generalised Vomiting Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 50 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8672432 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Jul-2012 8672432 EXPEDITED (15-DAY) Y OT QSC-2012-0116 43 YR Female USA Preferred Term Product Role Route Dosage Text Stevens-Johnson syndrome H.P. ACTHAR S 80 UNITS, QD, SUBCUTANEOUS Erythema multiforme AMOXICILLIN C Drug hypersensitivity VIT D (ERGOCALCIFEROL) C FOLIC ACID C HYDROCHLOROTHIAZIDE C LORATIDINE C VIT C (ASCORBIC ACID) C LEXAPRO C CRANBERRY (VACCINIUM MACROCARPON) C BISACODYL (BISACODYL) C PROVIGIL C BACLOFEN C GABAPENTIN (GABAPENTIN) C COUMADIN C DONEPEZIL HYDROCHLORIDE C TEMAZEPAM C LOPERAMIDE HYDROCHLORIDE C NYSTOP (NYSTATIN) C HYDROCODONE BITARTRATE & ACETAMINOPHEN C PROMETHAZINE C Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Duration Manufacturer Page: 51 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8698231 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Jul-2012 8698231 EXPEDITED (15-DAY) Y DS,OT QSC-2012-0128 63 YR Male USA Preferred Term Product Role Route Dosage Text Obliterative bronchiolitis ACTHAR S 0/8 ML THREE TIMES PER WEEK ; 0.8 ML, IW CELLCEPT S ASPIRIN (CHILDREN (ACETYLSALICYLIC ACID) C BENICAR C FUROSEMIDE (FUROSEMIDE) C METOLAZONE C POTASSIUM CHLORIDE C VITAMIN D 2000 (CALCIUM CARBONATE, COLECALCIFEROL) C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 52 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8715173 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 25-Jul-2012 8715173 EXPEDITED (15-DAY) Y DE FK201201939 213 DAY Female Preferred Term Product Role Route Dosage Text Herpes zoster ACYCLOVIR SODIUM S INTRAVENOUS (NOT OTHERWISE SPECIFIED) Multi-organ failure CORTICOTROPIN S 0.005 MG/KG, ONCE EVERY MORNING Disseminated intravascular coagulation HUMAN IMMUNOGLOBULIN G S INTRAVENOUS (NOT OTHERWISE SPECIFIED) General physical health deterioration VALPROATE SODIUM C Shock haemorrhagic ZONISAMIDE C Sex Duration Country JPN Manufacturer Ascites Brain oedema Capillary leak syndrome Cardiovascular insufficiency Haemorrhage intracranial Hepatic failure Pleural effusion Rash Respiratory distress Respiratory failure FDA Received Date 8710547 Case # Case Type Health Professional Outcomes 27-Jul-2012 8710547 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Skin irritation ACTHAR S 1 ML (80 UNITS DAILY) IM INTRAMUSCULAR Age Sex Country 65 YR Male USA Duration Manufacturer QUESTCOR Abdominal distension Drug ineffective Hallucination Palpitations Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 53 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8734893 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Aug-2012 8734893 EXPEDITED (15-DAY) Y DE QSC-2012-0141 71 YR Male USA Preferred Term Product Role Route Dosage Text Acute coronary syndrome ADRENOCORTICOTROPIC HORMONE S 80 UNITS, BIW, SUBCUTANEOUS Sudden death CELLCEPT C UNSPECIFIED INGREDIENTS C SUBCUTANEOUS FDA Received Date 8758199 Case # Case Type Health Professional Outcomes Manufacturer Control # 14-Aug-2012 8758199 EXPEDITED (15-DAY) Y OT QSC-2012-0162 Preferred Term Product Role Route Anaemia ADRENOCORTICOTROPIC HORMONE S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text INTRAMUSCULAR Note: If the field is blank, there is no data Duration Age Duration Manufacturer Sex Country Unknown USA Manufacturer 7 DAY Page: 54 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8725672 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Aug-2012 8725672 EXPEDITED (15-DAY) Y OT USABBOTT-12P-163-09625 30-00 30 YR Female USA Preferred Term Product Role Route Thrombocytopenia VALPROATE SODIUM S Status epilepticus PHENOBARBITAL S Drug effect decreased PENTOBARBITAL SODIUM S Rash FOSPHENYTOIN S MIDAZOLAM S Continuous drip PROPOFOL S Drip TOPIRAMATE S Max dose 400 mg daily LEVETIRACETAM S Max 2500 mg twice daily OXCARBAZEPINE S Max 1200 mg twice daily NEURONTIN S Max 1200 mg three times daily HUMAN IMMUNOGLOBULIN G S 0.4 mg/kg/day ACETAZOLAMIDE S Max 500 mg twice daily CORTICOTROPIN S ACYCLOVIR C VANCOMYCIN C CEFTRIAXONE C BENZODIAZEPINE RELATED DRUGS C MAGNESIUM C KETAMINE HYDROCHLORIDE C Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Duration Manufacturer 4-5 mg/kg/hr Note: If the field is blank, there is no data 5 DAY 2 WEEK Page: 55 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8742728 Case # Case Type Health Professional Outcomes Manufacturer Control # 17-Aug-2012 8742728 EXPEDITED (15-DAY) Y OT DKLU1083632 Preferred Term Product Role Route Convulsion ONFI S Drug ineffective VALPROIC ACID S Drop attacks TOPIRAMATE S Fall CLONAZEPAM S Head injury PHENYTOIN S Developmental delay LAMOTRIGINE (LAMOTRIGINE) S GABAPENTIN (GABAPENTIN) S CARBAMAZEPINE S PHENOBARBITAL S CORTICOTROPIN (CORTICOTROPIN) S ZONISAMIDE C SULTIAME (SULTIAME) C FDA Received Date 8817060 Case # Case Type Health Professional Outcomes 03-Oct-2012 8817060 DIRECT Y OT Dosage Text Manufacturer Control # Preferred Term Product Role Route Dosage Text Swelling ACTHAR S 80 units, subq SUBCUTANEOUS Age Sex Country Male JPN Duration Manufacturer Age Sex Country 45 YR Female USA Duration Manufacturer FDA Received Date 8758203 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Oct-2012 8758203 EXPEDITED (15-DAY) Y DE,HO QSC-2012-0164 8 YR Female USA Preferred Term Product Role Route Syncope ADRENOCORTICOTROPIC HORMONE S Sudden death KLONOPIN (CLONAZEPAM) (TABLETS) S Anger TOPAMAX (TOPIRAMATE) S GEODON S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text INTRAMUSCULAR Note: If the field is blank, there is no data Duration Manufacturer 7 DAY Page: 56 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8844620 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Oct-2012 8844620 EXPEDITED (15-DAY) Y HO,OT QSC-2012-0160 4 YR Female USA Preferred Term Product Role Route Dosage Text Neutropenia ADRENOCORTICOTROPIC HORMONE S 14 IU, qod, Intramuscular BACTRIM C ZANTAC (RANITIDINE HYDROCHLORIDE) C FDA Received Date 8855903 Case # Case Type Health Professional 22-Oct-2012 8855903 DIRECT Y INTRAMUSCULAR Outcomes Preferred Term Product Role Route Exostosis ACTHAR S Manufacturer Control # Dosage Text SUBCUTANEOUS Duration Age Manufacturer Sex Country Female USA Duration Manufacturer 5 DAY Arthritis Hyperglycaemia FDA Received Date 8909726 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Nov-2012 8909726 EXPEDITED (15-DAY) Y DE QSC-2012-0288 57 YR Male USA Preferred Term Product Role Route Dosage Text Myocardial infarction H.P. ACTHAR S UNK, biw, Subcutaneous SUBCUTANEOUS Duration Manufacturer Cardiac arrest FDA Received Date 8909731 Case # Case Type Health Professional Outcomes Manufacturer Control # 09-Nov-2012 8909731 EXPEDITED (15-DAY) Y HO QSC-2012-0285 Preferred Term Product Role Route Dosage Text Adrenal disorder H.P. ACTHAR S UNK Age Sex Country Male USA Duration Manufacturer Blood electrolytes decreased FDA Received Date 8816526 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Nov-2012 8816526 EXPEDITED (15-DAY) Y DE,HO,OT QSC-2012-0203 70 YR Female USA Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 57 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8816526 Preferred Term Product Role Route Respiratory failure ADRENOCORTICOTROPHIC HORMONE S Inappropriate antidiuretic hormone secretion LOSARTAN (LOSARTAN) C Oesophagitis SPIRONOLACTONE (SPIRONOLACTONE) C Gastrointestinal haemorrhage LASIX (FUROSEMIDE) C KEPPRA (LEVETIRACETAM) C PLAVIX (CLOPIDOGREL BISULFATE) C Oxygen saturation decreased AMLODIPINE (AMLODIPINE) C Hypophagia LABETALOL (LABTALOL) C Pneumonia aspiration ALPRAZOLAM (ALPRAZOLAM) C LEVOTHYROXINE (LEVOTHYROXINE) C CRSETOR (ROSUVASTATIN CALCIUM) C OMEPRAZOLE (OMEPRAZOLE) C ACETAMINOPHEN (PARACETAMOL) C OXYCODONE (OXYCODONE) C ASPIRIN (ACETYLSALICYCLIC AICD) C SALT (SODIUM CHLORIDE) C MAGNESIUM OXIDE (MAGNESIUM OXIDE) C VITAMIN D NOS (VITAMIN D NOS) C CALCIUM CITRATE (CALCIUM CITRATE) C Dosage Text Duration Manufacturer INTRAMUSCULAR Abscess intestinal Diverticular perforation General physical health deterioration Hyponatraemia Hypotension Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 58 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8816526 Preferred Term Product Role Route Dosage Text Duration Manufacturer Pallor Pneumonia aspiration Pulmonary embolism FDA Received Date 8913498 Case # Case Type Health Professional 14-Nov-2012 8913498 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country OT QSC-2012-0281 75 YR Male USA Preferred Term Product Role Route Pneumothorax ACTHAR S Dosage Text Duration Manufacturer Anxiety Asthenia Cough Dyspepsia Faecal incontinence Fall Fatigue Fluid retention Gait disturbance Gastrointestinal motility disorder Hypophagia Joint stiffness Joint swelling Local swelling Nausea Rib fracture Sleep disorder Syncope Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 59 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8984049 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Dec-2012 8984049 EXPEDITED (15-DAY) Y DE,HO OSC-2012-0336 64 YR Female USA Preferred Term Product Role Route Cerebrovascular accident H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S TYSABRI C ADDERALL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE) C AMBIEN (ZOLPIDEM TARTRATE) C FIORICET (BUTALBITAL, CAFFEINE, PARACETAMOL) C FLEXERIL (CYCLOBENZAPRINE HYDROCHLORIDE) C LANTUS (INSULIN GLARGINE) C LASIX (FUROSEMIDE) C CYMBALTA (DULOXETINE HYDROCHLORIDE) C DETROL LA (TOLTERODINE LTARTRATE) C PEPCID (FAMOTIDINE) C LIPITOR (ATORVASTATIN CALCIUM) C LISINOPRIL (LISINOPRIL) C Dosage Text Duration Manufacturer Malaise Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 60 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8974776 Case # Case Type Health Professional Outcomes 18-Dec-2012 8974776 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Acne ACTHAR S 40 units Monday and Friday SQ Weight increased VIT D C ENALAPRIL C SUBCUTANEOUS Age Sex Country 32 YR Female USA Duration Manufacturer QUESTCOR Headache FDA Received Date 8978901 Case # Case Type 18-Dec-2012 8978901 DIRECT Health Professional Outcomes Manufacturer Control # HO Preferred Term Product Role Route Dosage Text Blood pressure increased ACTHAR S 80 unites injection ACTHAR C Age Sex Country 63 YR Male USA Duration Manufacturer FDA Received Date 9006160 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 26-Dec-2012 9006160 EXPEDITED (15-DAY) Y DE QSC-2012-0361 59 YR Male USA Preferred Term Product Role Route Dosage Text Proteinuria H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units, unk, unknown HYDRALAZINE C LANTUS (INSULIN GLARGINE) C PREDNISONE C ALDACTONE (SPIRONOLACTONE) C FUROSEMIDE C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 61 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9034030 Case # Case Type Health Professional Outcomes 16-Jan-2013 9034030 DIRECT Y HO Manufacturer Control # Preferred Term Product Role Route Dosage Text Palpitations H.P. ACTHAR S 80 U IM QD INTRAMUSCULAR Age Sex Country 30 YR Female USA Duration Manufacturer QUESTCOR Arrhythmia FDA Received Date 9006156 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Jan-2013 9006156 EXPEDITED (15-DAY) Y HO QSC-2012-0299 34 YR Female USA Preferred Term Product Role Route Dosage Text Cardiomyopathy ACTHAR GEL-SYNTHETIC S 40 units Influenza like illness PREDNISONE (PREDNISONE) C AZITHROMYCIN (AZITHROMYCIN) C CELEXA (CITALOPRAM HYDROBROMIDE) C FUROSEMIDE (FUROSEMIDE) C LABETALOL (LAETALOL) C LOSARTAN (LOSARTAN) C VITAMIN D (COLECALCIFEROL) C SUBCUTANEOUS Duration Manufacturer Hypersensitivity Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 62 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8960572 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 31-Jan-2013 8960572 EXPEDITED (15-DAY) Y OT DKLU1086655 213 DAY Female Preferred Term Product Role Route Haematochezia SABRIL S CLONAZEPAM (CLONAZEPAM) (CLONAZEPAM) C ZONEGRAN (ZONISAMIDE) C PEPCID (FAMOTIDINE) C POLYETHYLENE GLYCOL (MACROGOL) C Dosage Text Sex Duration Country USA Manufacturer ORAL Constipation Eye movement disorder Hemiparesis Movement disorder Seizure cluster FDA Received Date 8967662 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Feb-2013 8967662 EXPEDITED (15-DAY) Y HO QSC-2012-0326 2 YR Male USA Preferred Term Dilatation intrahepatic duct congenital Product Role Route Dosage Text H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 40 units, bid, Intramuscular IMMUNOGLOBULIN (IMMUNOGLOBULINS NOS) C INTRAMUSCULAR Duration Manufacturer Anaemia Hypoalbuminaemia Hyponatraemia Oesophageal varices haemorrhage Pleural effusion Sinus bradycardia Upper gastrointestinal haemorrhage Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 63 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9094388 Case # Case Type Health Professional 04-Feb-2013 9094388 DIRECT Y Outcomes Preferred Term Product Role Route Influenza ACTHAR S Manufacturer Control # Dosage Text FDA Received Date 9146647 Case # Case Type Health Professional Outcomes Manufacturer Control # 07-Feb-2013 9146647 EXPEDITED (15-DAY) Y DE,HO QSC-2013-0021 Preferred Term Product Role Route Dosage Text H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units, biw, Subcutaneous 01/--/2013 to UNK SUBCUTANEOUS Age Sex Country Female USA Duration Age Manufacturer Sex Country Male USA Duration Manufacturer Lung infection Pneumonia FDA Received Date 9093460 Case # Case Type Health Professional 13-Feb-2013 9093460 DIRECT Y Outcomes Preferred Term Product Role Route Flushing ACTHAR S Manufacturer Control # Dosage Text SUBCUTANEOUS Age Duration Sex Country Female USA Manufacturer QUESTCOR Local swelling Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 64 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9146182 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 13-Feb-2013 9146182 EXPEDITED (15-DAY) Y HO QSC-2013-0029 70 YR Male USA Preferred Term Product Role Route Dosage Text Pulmonary oedema H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units, biw, Subcutaneous ALLOPURINOL C ASPIRIN (ACETYLSALICYLIC ACID) C ATORVASTATIN (ATORVASTATIN) C AVAPRO (IRBESARTAN) C COLCHICINE (COLCHICINE) C DEPAKOTE (VALPROATE SEMISODIUM) C LABETALOL (LABETALOL) C MINOXIDIL (MINOXIDIL) C NORVASC (AMLODIPINE BESILATE) C TRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE, TRIAMTERENE) C VITAMIN D3 (COLECALCIFEROL) C CENTRUM (MINERAL NOS, VITAMINS NOS) C SUBCUTANEOUS Duration Manufacturer Hypertension Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 65 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9154692 Case # Case Type Health Professional 13-Feb-2013 9154692 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO QSC-2013-0015 46 YR Male USA Preferred Term Product Role Route Pneumothorax H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Pneumothorax LASIX (FUROSEMDIE) C Bacterial infection SPIRONOLACTONE (SPIRONOLACTONE) C Urinary retention BACTRIM C OXYCODONE (OXYCODONE) C WARFARIN (WARFARIN) C TAMSULOSIN (TAMSULOSIN) C COZAAR (LOSARTAN POTASSIUM) C Dosage Text Duration Manufacturer SUBCUTANEOUS Atrial fibrillation Empyema Infection Nephrotic syndrome Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 66 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9149444 Case # Case Type 01-Mar-2013 9149444 DIRECT Health Professional Outcomes Manufacturer Control # Age OT Preferred Term Product Role Route Dosage Text Duration Injection site discolouration ACTHAR S 1 ML 2 injections week1 sq 6 MTH SUBCUTANEOUS Sex Country Male USA Manufacturer Asthenia Blood creatinine increased Blood pressure fluctuation Capillary fragility Injection site reaction Mood swings Pulse abnormal Sleep disorder Tremor Weight decreased FDA Received Date 9146168 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Mar-2013 9146168 EXPEDITED (15-DAY) Y DE QSC-2013-0036 64 YR Male USA Preferred Term Product Role Route Acute pulmonary oedema H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Duration Manufacturer INTRAMUSCULAR Cardiac failure Respiratory failure Sudden death Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 67 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9169062 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Mar-2013 9169062 EXPEDITED (15-DAY) Y HO QSC-2013-0054 10 YR Male USA Preferred Term Product Role Route Dosage Text Subclavian vein thrombosis H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units Coagulation time prolonged LISINOPRIL (LISINOPRIL DIHYDRATE) (UNKNOWN C LOSARTAN (LOSARTAN POTASSIUM) C SYMBICORT C CETIRIZINE (CETIRIZINE) C ERGOCALCIFEROL (ERGOCALCIFEROL) C LASIX (FUROSEMIDE) C Duration Manufacturer Jugular vein thrombosis FDA Received Date 9167978 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Mar-2013 9167978 EXPEDITED (15-DAY) Y DS,OT 2013034874 25 YR Female USA Preferred Term Product Role Route Asthenia INTRAVENOUS IMMUNOGLOBULIN (IVIG) (IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10% LIQUID) S MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) S METHYLPREDNISOLONE (METHYLPREDNISOLONE) S TACROLIMUS (TACROLIMUS) S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Manufacturer Page: 68 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9168007 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Mar-2013 9168007 EXPEDITED (15-DAY) Y DS,OT 2013034804 25 YR Female USA Preferred Term Product Role Route Walking aid user METHYLPREDNISOLONE (METHYLPREDNISOLONE) S No therapeutic response TACROLIMUS (TACROLIMUS) S Dosage Text Duration Manufacturer 8 WEEK Condition aggravated Dermatomyositis Muscle atrophy Muscular weakness Off label use FDA Received Date 9168038 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Mar-2013 9168038 EXPEDITED (15-DAY) Y OT 2013034867 45 YR Female USA Preferred Term Product Role Route Muscular weakness INTRAVENOUS IMMUNOGLOBULIN S Rash AZATHIOPRINE S Nail disorder RITUXIMAB (RITUXIMAB) S Drug ineffective for unapproved indication CYCLOSPORINE (CICLOSPORIN) S Headache METHOTREXATE (METHOTREXATE) S Chills PREDNISONE (PREDNISONE) S Nausea HP ACTHAR (CORTICOTROPIN) S Dosage Text Duration Manufacturer Condition aggravated Dermatomyositis FDA Received Date 9167448 Case # Case Type Health Professional Outcomes 13-Mar-2013 9167448 DIRECT Y HO Manufacturer Control # Preferred Term Product Role Route Dosage Text Proteinuria ACTHAR HP S 80u/1ml 5 ml vial Age Sex Country 21 YR Female USA Duration Manufacturer QUESTCOR No therapeutic response Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 69 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9168636 Case # Case Type Health Professional Outcomes 14-Mar-2013 9168636 DIRECT Y HO,LT Preferred Term Product Role Route Vision blurred ACTHAR GEL-SYNTHETIC S Manufacturer Control # Dosage Text Age Sex Country 37 YR Female USA Duration Manufacturer SUBCUTANEOUS QUESTCOR Blood potassium decreased Heart rate decreased FDA Received Date 9263568 Case # Case Type Health Professional Outcomes 29-Apr-2013 9263568 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Tremor ACTHAR S 1 ml biw subcutaneous Feeling jittery PREDNISONE C SUBCUTANEOUS Age Sex Country 29 YR Female USA Duration Manufacturer Palpitations FDA Received Date 9264760 Case # Case Type Health Professional 29-Apr-2013 9264760 DIRECT Y Outcomes Manufacturer Control # Preferred Term Product Role Route Dosage Text Alopecia ACTHAR S 80 units Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Age Sex Country 36 YR Female USA Duration Manufacturer QUESTCOR Page: 70 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9217386 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-May-2013 9217386 EXPEDITED (15-DAY) Y HO QSC-2013-0088 74 YR Male USA Preferred Term Product Role Route Dosage Text Myopathy H.P. ACTHAR GEL S 80 UNITS, BIW, SUBCUTANEOUS Asthenia BUMEX (BUMETANIDE) C POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) C VITAMIN D (ERGOCALCIFEROL) C ASPIRIN LOW (ACETYLSALICYLIC ACID) C COREG (CARVEDILOL) C CALCITRIOL (CALCITRIOL) C FISH OIL (FISH OIL) C ALDACTONE (SPIRONOLACTONE) C DILTIAZEM C FLOMAX (MORNIFLUMATE) C HYDRALAZINE (HYDRALAZINE) C MAGNESIUM (MAGNESIUM SULFATE) C SUBCUTANEOUS Duration Manufacturer Blood glucose increased Deep vein thrombosis FDA Received Date 9277342 Case # Case Type Health Professional Outcomes 03-May-2013 9277342 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Muscle spasms ACTHAR S 0.4 cc bid x 7 d, o 18 cc .. c 6 d Age Sex Country 1 YR Male USA Duration Manufacturer Disease recurrence Drug ineffective Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 71 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9302647 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 17-May-2013 9302647 EXPEDITED (15-DAY) Y HO QSC-2013-0131 273 DAY Male Preferred Term Product Role Route Dosage Text Ventricular extrasystoles H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 75 units/m2, for 2 wks Duration Sex Country USA Manufacturer Hypertension Ventricular tachycardia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 72 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9302656 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-May-2013 9302656 EXPEDITED (15-DAY) Y HO QSC-2013-0128 59 YR Female USA Preferred Term Product Role Route Dosage Text Atrial fibrillation H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units Coronary artery embolism COPAXONE (GLATIRAMER ACETATE) C Eye haemorrhage DOXEPIN C Snoring OMEPRAZOLE C Erythema ESTROGEN (ESTRADIOL) C LISINOPRIL C METOPROLOL C RANITIDINE (RANITIDINE) C SIMVASTATIN C WARFARIN C PROGRAF (TACROLIMUS) C PREDNISONE C SUBCUTANEOUS Duration Manufacturer Amaurosis fugax Dyspnoea exertional Infusion site infection Palpitations Sleep apnoea syndrome Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 73 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9302068 Case # Case Type Health Professional 21-May-2013 9302068 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country OT USBAXTER-2013BAX01683 4 46 YR Female USA Preferred Term Product Role Route Hyponatraemia 5% DEXTROSE INJECTION USP S 5% DEXTROSE INJECTION USP S ACTH S DEXAMETHASONE S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text UNKNOWN Duration Manufacturer BAXTER BAXTER UNKNOWN Note: If the field is blank, there is no data Page: 74 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9331876 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Jun-2013 9331876 EXPEDITED (15-DAY) Y HO ACO_35816_2013 47 YR Male USA Preferred Term Product Role Route Fall AMPYRA S Constipation TESTOSTERONE (TESTOSTERONE PROPIONATE) C Drug dose omission OXYCODONE HCL (OXYCODONE HYDROCHLORIDE) C Blood potassium decreased OXYCONTIN (OXYCODONE HYDROCHLORIDE) C XANAX (ALPRAZOLAM) C ADDERALL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE) C CLARITIN (LORATADINE) C PRENATAL (ASCORBIC ACID, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, ERGOCALCIFEROL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE) C COSAMIN (CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE) C ZOFRAN (ONDANSETRON HYDROCHLORIDE) C ABILIFY (ARIPIPRAZOLE) C SOMA CMPD (ACETYLSALICYLIC ACID, CARISOPRODOL) C Dosage Text Duration Manufacturer ORAL Balance disorder Insomnia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 75 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9341353 Case # Case Type Health Professional Outcomes 10-Jun-2013 9341353 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Dyspnoea ACTHAR S 80u/ml Injectable 1 tiw FDA Received Date 9350575 Case # Case Type Health Professional Outcomes 13-Jun-2013 9350575 DIRECT Y HO Manufacturer Control # Preferred Term Product Role Route Dosage Text Migraine ACTHAR GEL-SYNTHETIC S 40 U QD SUBCUTANEOUS Muscular weakness CLONAZEPAM C VALIUM C CYMBALTA C ZOFRAN C TORADOL C DHE C PHENERGAN C BENEDRYL C SUBCUTANEOUS Age Sex Country 69 YR Female USA Duration Manufacturer Age Sex Country 60 YR Male USA Duration Manufacturer QUESTCOR Dyskinesia Psychogenic seizure FDA Received Date 9375492 Case # Case Type Health Professional 28-Jun-2013 9375492 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country ES-EISAI INCE2090-02715-SPO-ES 9 DAY Male ESP Preferred Term Product Role Route Dosage Text Drug ineffective ZONISAMIDE S UNKNOWN PHENOBARBITAL S UNKNOWN LEVETIRACETAM S UNKNOWN CLONAZEPAM S UNKNOWN VIGABATRIN S UNKNOWN ACTH S UNKNOWN Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 76 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9317308 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jul-2013 9317308 EXPEDITED (15-DAY) Y DE,HO QSC-2013-0140 72 YR Female USA Preferred Term Product Role Route Dosage Text Pancytopenia ADRENOCORTICOTROPIC HORMONE S 80 units, bid, Subcutaneous Acute respiratory failure FUROSEMIDE (FUROSEMIDE) C Oedema peripheral CARVEDILOL (CARVEDILOL) C Oedema ISISORBIDE DINITRATE (ISISORBIDE DINITRATE) C Sepsis VITAMIN D NOS (VITAMIN D NOS) C TYLENOL WITH CODEIN #3 (CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL) C FISH OIL (FISH OIL) C FENOFIBRATE 9FENOFIBRATE) C ALLOPURINOL C THYROID (THYROID) C SUBCUTANEOUS Duration Manufacturer Defaecation urgency Heart rate irregular Lower gastrointestinal haemorrhage Peritonitis Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 77 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9278845 Case # Case Type Health Professional 09-Jul-2013 9278845 NON-EXPEDITED Outcomes Manufacturer Control # Age Sex Country US-PFIZER INC-2013141522 42 YR Male USA Preferred Term Product Role Route Dosage Text Drug hypersensitivity Neurontin S UNK PFIZER Urticaria AMOXICILLIN S UNK PFIZER ERYTHROMYCIN S UNK AMOXIL S UNK MOTRIN S UNK ATCH S UNK KEFLEX S UNK Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 78 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9364414 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Jul-2013 9364414 EXPEDITED (15-DAY) Y HO QSC-2013-0116 41 YR Female USA Preferred Term Product Role Route Colitis ischaemic H.P. ACTHAR GEL S Enterocolitis infectious LISINOPRIL (LISINOPRIL) C Rectal haemorrhage AMLODIPINE (AMLODIPINE) C Hypernatraemia CALCIUM ACETATE (CALCIUM ACETATE) C Hypokalaemia CLONIDINE (CLONIDINE) C Hypoalbuminaemia HYDRALAZINE (HYDRALAZINE) C Anxiety LACTULOSE (LACTULOSE) C Blood pressure increased METOPROLOL (METOPROLOL) C Local swelling FISH OIL (FISH OIL) C Asthenia PANTOPRAZOLE (PANTOPRAZOLE) C Dosage Text Duration Manufacturer Abdominal pain Anaemia Diverticulitis Hypomagnesaemia Iron deficiency anaemia Malaise Renal failure acute Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 79 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9355528 Case # Case Type Health Professional 19-Jul-2013 9355528 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO,OT US-SANOFIAVENTIS-2013SA06082 9 47 YR Male USA Preferred Term Product Role Route Multiple sclerosis relapse AUBAGIO S Blood potassium abnormal CORTICOTROPIN S Fall AMINOPYRIDINE, 2- S ORAL Insomnia AMINOPYRIDINE, 2- S ORAL Asthenia TESTOSTERONE C Balance disorder OXYCODONE HYDROCHLORIDE C Constipation OXYCONTIN C Transient ischaemic attack XANAX C ADDERALL C CLARITIN C PRENATAL C COSAMIN C ZOFRAN C ABILIFY C ACETYLSALICYLIC ACID/ CARISOPRODOL C Dosage Text Duration Manufacturer ORAL FDA Received Date 9416928 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jul-2013 9416928 EXPEDITED (15-DAY) Y HO QSC-2013-0222 49 YR Female USA Preferred Term Product Role Route Coronary artery disease H.P. ACTHAR GEL S Fatigue HYDROCORTISONE (HYDROCORTISONE) C Dosage Text Duration Manufacturer Hypertension Pain in extremity Pain in jaw Tachycardia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 80 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9416932 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 22-Jul-2013 9416932 EXPEDITED (15-DAY) Y HO QSC-2013-0219 41 YR Female USA Preferred Term Product Role Route Dosage Text Cardiomyopathy H.P. ACTHAR GEL S 80 units, biw Mitral valve incompetence NORTRIPTYLINE (NORTRIPTYLINE) C Pulmonary hypertension OMEPRAZOLE (OMEPRAZOLE) C Atelectasis SINGULAIR C Dyspnoea NASONEX (MOMETASONE FUROATE) C Carditis MOBIC (MELOXICAM) C Headache ALBUTEROL (SALBUTAMOL) C Leukocytosis MULTIVITAMIN (VITAMINS NOS) C Duration Manufacturer Anxiety Aortic valve incompetence Cardiac failure congestive Hypertension Off label use Pleural effusion Sinus tachycardia Systolic dysfunction FDA Received Date 9422408 Case # Case Type Health Professional Outcomes 25-Jul-2013 9422408 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Swelling face ACTHAR S daily for 5 days Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Age Duration Sex Country Female USA Manufacturer QUESTCOR Page: 81 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9447412 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 06-Aug-2013 9447412 EXPEDITED (15-DAY) Y HO,OT QSC-2013-0235 70 YR Female USA Preferred Term Product Role Route Dosage Text Adenocarcinoma pancreas H. P. ACTHAR GEL S DOSAGE ADMINISTERED EVERY TWO WEEKS FOR SIX MONTHS. SUBCUTANEOUS Duration Manufacturer Dysgeusia Fatigue Hypoaesthesia Hypoaesthesia oral Somnolence Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 82 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9454717 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Aug-2013 9454717 EXPEDITED (15-DAY) Y DE,HO QSC-2013-0245 65 YR Female USA Preferred Term Product Role Route Dosage Text Septic shock H.P. ACTHAR GEL S 80 units Skin mass ALLOPURINOL C Haemoglobin decreased BYSTOLIC C Immunosuppression CALCITRIOL C Blood glucose increased CALCIUM CARBONATE W/ VITAMIN D NOS C Blood potassium decreased DOXAZOSIN C OMEPRAZOLE C PROCRIT C SPIRONOLACTONE C SYNTHROID C SUBCUTANEOUS Duration Manufacturer Blood chloride decreased Blood creatinine increased Haematocrit decreased Hypotension Impaired healing Local swelling Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 83 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9468659 Case # Case Type Health Professional Outcomes Manufacturer Control # 14-Aug-2013 9468659 EXPEDITED (15-DAY) Y HO QSC-2013-0257 Preferred Term Product Role Route Dosage Text Atrial fibrillation H.P. ACTHAL GEL S 80 UNITS, BID, SUBCUTANEOUS Heart rate increased ULTRAM C TUMS (CALCIUM CARBONATE) C NORVASC (AMLODIPINE BESILATE) C CRESTOR C COLCRYS (COLCHICINE) C CALCITROL (CALCITRIOL) C ALLOPURINOL C SUBCUTANEOUS Age Sex Country Male USA Duration Manufacturer Chest pain FDA Received Date 9496404 Case # Case Type Health Professional 04-Sep-2013 9496404 EXPEDITED (15-DAY) Outcomes Manufacturer Control # OT VEJNJFOC-20130815817 Preferred Term Product Role Route Encephalopathy TOPIRAMATE S ORAL Multiple-drug resistance VALPROIC ACID S UNKNOWN Off label use NITRAZEPAM S UNKNOWN LEVETIRACETAM S UNKNOWN ACTH S UNKNOWN Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Age Duration Sex Country Male VEN Manufacturer Page: 84 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9499889 Case # Case Type Health Professional Outcomes 04-Sep-2013 9499889 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Tremor ACTHAR S (1 ml) Feeling abnormal ACIDOPHILUS C Heart rate increased FOLIC ACID C XANAX C AZMACORT C IBUPROFEN C NAPROSYN C SYNTHROID C RITUXAN C LANOXIN C VIT D 3 C VIT B C VIT E C IMITREX C RESTASIS C INTRAMUSCULAR Age Sex Country 55 YR Female USA Duration Manufacturer QUESTCOR Asthenia Blood pressure increased FDA Received Date 9516520 Case # Case Type 10-Sep-2013 9516520 DIRECT Health Professional Outcomes Manufacturer Control # DE Preferred Term Product Role Route Sepsis ACTHAR HP S Dosage Text SUBCUTANEOUS Age Sex Country 69 YR Female USA Duration Manufacturer QUESTCOR Cellulitis Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 85 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9475464 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Sep-2013 9475464 EXPEDITED (15-DAY) Y HO QSC-2013-0274 60 YR Male USA Preferred Term Product Role Route Dosage Text Faeces discoloured H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units, biw, Subcutaneous HUMALOG (INSULIN LISPRO) C TRAMADOL (TRAMADOL) C CARDIAZEM (DILTIAZEM) C WELCHOL (COLESEVELAM HYDROCHLORIDE) (625 MILLIGRAM, TABLET) (COLESEVELAM HYDROCHLORIDE) C LISINOPRIL (LISINOPRIL) C DHEA (PRASTERONE) C CALCIUM WITH VITAMIN D (CALCIUM CARBONATE, COLECALCIFEROL) C PREDNISONE (PREDNISONE) C NEXIUM (ESOMEPRAZOLE MAGNESIUM) C SUBCUTANEOUS Duration Manufacturer Abdominal pain Gastrointestinal haemorrhage FDA Received Date 9523789 Case # Case Type Health Professional Outcomes 12-Sep-2013 9523789 DIRECT Y HO Preferred Term Product Role Route Deep vein thrombosis ACTHAR S Date - Time: 05-05-2014 8:35:59 AM EST Manufacturer Control # Dosage Text INTRAMUSCULAR Note: If the field is blank, there is no data Age Sex Country 82 YR Female USA Duration Manufacturer QUESTCOR Page: 86 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8337702 Case # Case Type Health Professional 16-Sep-2013 8337702 NON-EXPEDITED Outcomes Manufacturer Control # OT CNJNJFOC-20120104193 Preferred Term Product Role Route Infantile spasms TOPIRAMATE S ORAL Refusal of treatment by patient ACTH S INTRAVENOUS ACTH S INTRAVENOUS IVIG S INTRAVENOUS VITAMIN B6 S INTRAVENOUS PREDNISONE S ORAL FDA Received Date 9529176 Case # Case Type Health Professional 16-Sep-2013 9529176 NON-EXPEDITED US-LUNDBECKDKLU1089070 4 YR Female USA Lethargy SABRIL (TABLET) S Constipation HP ACTHAR S OTHER HP ACTHAR S OTHER LEVETIRACETAM S RANITIDINE HYDROCHLORIDE C DIRECT Manufacturer HO S 9530712 Duration Country Role Route 16-Sep-2013 CHN Sex Onfi Health Professional Unknown Age Product Case Type Country Manufacturer Control # Abdominal distension Case # Sex Outcomes Preferred Term FDA Received Date 9530712 Dosage Text Age Dosage Text Duration Manufacturer LUNDBECK LUNDBECK Outcomes 30 UNITS DAILY Manufacturer Control # OT Age Sex Country 24 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Abdominal pain upper ACTHAR S 80 units daily x5 days SQ 5 DAY QUESTCOR SUBCUTANEOUS Abdominal discomfort Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 87 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9528060 Case # Case Type Health Professional 17-Sep-2013 9528060 EXPEDITED (15-DAY) Outcomes Manufacturer Control # OT CNJNJFOC-20130907083 Preferred Term Product Role Route Dosage Text Developmental delay TOPIRAMATE S ORAL 25 to 200 mg per day (3.57 to 20 mg/kg/day Drug ineffective TOPIRAMATE S ORAL 0.5 to 1 mg/kg/day Convulsion VALPROIC ACID S UNKNOWN Off label use CLONAZEPAM S UNKNOWN Decreased appetite NITRAZEPAM S UNKNOWN Somnolence PHENYTOIN S UNKNOWN Hypohidrosis CARBAMAZEPINE S UNKNOWN Pyrexia LEVETIRACETAM S UNKNOWN Fatigue ACTH S UNKNOWN Insomnia PREDNISONE S UNKNOWN Age Sex Country Unknown CHN Duration Manufacturer Temperature intolerance Vomiting FDA Received Date 9552144 Case # Case Type Health Professional 23-Sep-2013 9552144 DIRECT Y Outcomes Preferred Term Product Role Route Musculoskeletal stiffness ACTHAR S Manufacturer Control # Dosage Text Age Sex Country 63 YR Female USA Duration Manufacturer Pain FDA Received Date 9562363 Case # Case Type Health Professional 26-Sep-2013 9562363 DIRECT Y Outcomes Manufacturer Control # Age Sex Country 69 YR Female USA Preferred Term Product Role Route Dosage Text Duration Incorrect dose administered ACTHAR S 1ml twice weekly, im. 1 MTH INTRAMUSCULAR Manufacturer Underdose Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 88 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9570828 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 27-Sep-2013 9570828 EXPEDITED (15-DAY) Y DE,HO QSC-2013-0327 42 YR Female USA Preferred Term Product Role Route Dosage Text Cerebrovascular accident H.P. ACTHAR GEL S 80 UNITS, QW, SUBCUTANEOUS CELLCEPT ( MYCOPHENOLATE MOFETIL) C PREDNISONE ( PREDNISONE) C SYNTHROID ( LEVOTHYROXINE SODIUM) C LASIX ( FUROSEMIDE) C FDA Received Date 9586029 Case # Case Type Health Professional 02-Oct-2013 9586029 DIRECT Y SUBCUTANEOUS Outcomes Manufacturer Control # Duration Age Sex Country 59 YR Female USA Preferred Term Product Role Route Dosage Text Duration Oedema ACTHAR S 40 U 2 MTH FDA Received Date 9592560 Case # Case Type Health Professional Outcomes 03-Oct-2013 9592560 DIRECT Y HO Preferred Term Product Role Route Blood glucose increased ACTHAR S Date - Time: 05-05-2014 8:35:59 AM EST Manufacturer Control # Dosage Text Note: If the field is blank, there is no data Manufacturer Manufacturer Age Sex Country 72 YR Male USA Duration Manufacturer QUESTCOR Page: 89 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9596839 Case # Case Type Health Professional 04-Oct-2013 9596839 EXPEDITED (15-DAY) Outcomes Manufacturer Control # OT US-US-EMD SERONO, INC.-7227598 Preferred Term Product Role Route Blood glucose increased REBIF S SUBCUTANEOUS Swelling face REBIF S SUBCUTANEOUS Tremor ACTHAR S Dosage Text Age Sex Country Female USA Duration Manufacturer Injection site bruising Injection site scar Multiple sclerosis relapse FDA Received Date 9607583 Case # Case Type 07-Oct-2013 9607583 DIRECT Health Professional Outcomes Manufacturer Control # HO,DS,LT Preferred Term Product Role Route Dosage Text Dyspnoea ACTHAR S 1 mL two times a week inject, --, Into the muscle INTRAMUSCULAR Age Sex Country 66 YR Female USA Duration Manufacturer QUESTCOR Alopecia Blood calcium abnormal Blood cholesterol increased Blood magnesium abnormal Blood potassium abnormal Blood pressure abnormal Cataract Deafness Diabetes mellitus Immune system disorder Muscular weakness Nail disorder Rotator cuff syndrome Skin wrinkling Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 90 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9615343 Case # Case Type Health Professional Outcomes 10-Oct-2013 9615343 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Drug ineffective ACTHAR GEL 80 UNITS/ML S 80 units, twice a week, subcutaneous FDA Received Date 9616604 Case # Case Type Health Professional Outcomes 10-Oct-2013 9616604 DIRECT Y HO Preferred Term Product Role Route Ulcer haemorrhage ACTHAR S Manufacturer Control # Dosage Text Age Sex Country 45 YR Female USA Duration Manufacturer QUESTCOR Age Sex Country 58 YR Male USA Duration Manufacturer SUBCUTANEOUS Helicobacter infection FDA Received Date 9109038 Case # Case Type Health Professional 14-Oct-2013 9109038 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO US-UCBSA-078731 4 YR Female USA Preferred Term Product Role Route Constipation LEVETIRACETAM S Abdominal distension H. P. ACTHAR GEL S SUBCUTANEOUS Lethargy H. P. ACTHAR GEL S SUBCUTANEOUS VIGABATRIN S CLOBAZAM S RANITIDINE HYDROCHLORIDE C Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Duration Manufacturer TAPERED DAILY DOSE : 30 UNITS Note: If the field is blank, there is no data Page: 91 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 8473424 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Oct-2013 8473424 EXPEDITED (15-DAY) Y DE,HO,OT QSC-2012-0015 56 YR Male USA Preferred Term Product Role Route Dosage Text Asthenia H.P. ACTHAR S SUBCUTANEOUS 80 units, biw, Subcutaneous PROGRAF S ORAL 500 mg, bid, oral CELLCEPT S ORAL SIMVASTATIN C LOVAZA C Acute respiratory distress syndrome Pneumonia Duration Manufacturer Fungal infection Incorrect drug administration duration Sensation of heaviness Skin lesion Weight decreased Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 92 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9630650 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Oct-2013 9630650 EXPEDITED (15-DAY) Y HO QSC-2013-0339 54 YR Female USA Preferred Term Product Role Route Dosage Text Malignant hypertension H.P. ACTHAR S 40 units, qw, Subcutaneous Cardiac failure congestive LASIX (FUROSEMIDE) C Anaemia of chronic disease COZAAR (LOSARTAN POTASSIUM) (50 MILLIGRAM, TABLETS) (LOSARTAN POTASSIUM) C Treatment noncompliance CARDURA (DOXAZOSIN MESILATE) C Blood glucose increased CARVEDILOL (CARVEDILOL) C LANTUS (INSULIN GLARGINE) C NOVOLOG (INSULIN ASPART) C LIPITOR (ATORVASTIN CALCIUM) C NEXIUM I.V. C VICTOZA (LIRAGLUTIDE) C SUBCUTANEOUS Duration Manufacturer Local swelling Pericardial effusion Renal failure acute FDA Received Date 9630656 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Oct-2013 9630656 EXPEDITED (15-DAY) Y HO QSC-2013-0362 18 YR Male USA Preferred Term Product Role Route Dosage Text Pleural effusion H.P. ACTHAR S 80 units, biw, Subcutaneous Nephrotic syndrome CYCLOSPORINE (CICLOSPORIN) C SUBCUTANEOUS Duration Manufacturer Fluid overload Treatment failure Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 93 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9630665 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Oct-2013 9630665 EXPEDITED (15-DAY) Y HO QSC-2013-0363 60 YR Female USA Preferred Term Product Role Route Dosage Text Ischaemic stroke H.P. ACTHAR S 40 units, biw, Subcutaneous SUBCUTANEOUS Duration Manufacturer FDA Received Date 9640371 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Oct-2013 9640371 EXPEDITED (15-DAY) Y HO QSC-2013-0361 39 YR Female USA Preferred Term Product Role Route Intracranial pressure increased H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Papilloedema LISINOPRIL (LISINOPRIL) C Paraesthesia LISINOPRIL (LISINOPRIL) C Headache IBUPROFEN (IBUPROFEN) C Blood pressure increased AVONEX (INTERFERON BETA-1A) C Dosage Text Duration Manufacturer SUBCUTANEOUS Asthenopia Epistaxis Hyperacusis Musculoskeletal stiffness Photopsia Visual impairment Weight increased FDA Received Date 9651025 Case # Case Type Health Professional Outcomes 28-Oct-2013 9651025 DIRECT Y HO Preferred Term Product Role Route Hypersensitivity ACTHAR HP S Date - Time: 05-05-2014 8:35:59 AM EST Manufacturer Control # Dosage Text SUBCUTANEOUS Note: If the field is blank, there is no data Age Sex Country 81 YR Male USA Duration Manufacturer QUESTCOR Page: 94 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9671172 Case # Case Type 05-Nov-2013 9671172 DIRECT Health Professional Outcomes Manufacturer Control # HO,LT Preferred Term Product Role Route Lethargy ACTHAR S Dosage Text Age Sex Country 61 YR Male USA Duration Manufacturer QUESTCOR Blood pressure decreased Body temperature increased Dyspnoea Feeling abnormal Hyperhidrosis FDA Received Date 9640359 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Nov-2013 9640359 EXPEDITED (15-DAY) Y HO QSC-2013-0360 65 YR Male USA Preferred Term Product Role Route Dosage Text Renal failure chronic H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 80 units, biw, subcutaneous Fluid overload RAPAMUNE (SIROLIMUS) C Postoperative ileus CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET C Dialysis METHIMAZOLE (THIAMAZOLE) C Weight increased AMLODIPINE (AMLODIPINE) C ASPIRIN (ACETYLSALICYLIC ACID) C ATORVASTATIN (ATORVASTATIN) C CALCIUM CARBONATE (CALCIUM CARBONATE) C CARVEDILOL (CARVEDILOL) C DOCUSATE SODIUM (DOCUSATE SODIUM) C FLUTICASONE )FLUTICASONE) C LORTAB (HYDROCODONE BITARTRATE, PARACETAMOL) C Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Duration Manufacturer Page: 95 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9640359 Preferred Term Product Role Route LANTUS )INSULIN GLARGINE) C NEPHRON FA (ASCORBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, DOCUSATE SODIUM, FERROUS FUMARATE, FOLIC, NICOTINAMIDE, PYRIDOXINE, HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE) C ESOMEPRAZOLE (ESOMEPRAZOLE) C TACROLIMUS (TACROLIMUS) C MIRALAX C FLOMAX (TAMSULOSIN HYDROCHLORIDE) C Dosage Text Duration Manufacturer Abdominal wall haemorrhage Dyspnoea Fluid retention Oedema FDA Received Date 9690612 Case # Case Type Health Professional Outcomes 14-Nov-2013 9690612 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Migraine ACTHAR S 100 units QD SUBCUTANEOUS Palpitations BACLOFEN C ASA C PERCOCET C SUBCUTANEOUS Age Sex Country 53 YR Female USA Duration Manufacturer Flushing Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 96 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9692621 Case # Case Type 15-Nov-2013 9692621 DIRECT Health Professional Outcomes Manufacturer Control # OT Preferred Term Product Role Route Dosage Text Joint swelling ACTHAR HP S Injectable, Diagnosis: 340 FDA Received Date 9718328 Case # Case Type Health Professional Outcomes Manufacturer Control # 25-Nov-2013 9718328 EXPEDITED (15-DAY) Y HO QSC-2013-0421 Preferred Term Product Role Route Pulmonary embolism H.P. ACTHAR S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Age Sex Country 68 YR Female USA Duration Age Duration Manufacturer Sex Country Female USA Manufacturer Page: 97 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9722567 Case # Case Type Health Professional 02-Dec-2013 9722567 EXPEDITED (15-DAY) Outcomes Manufacturer Control # HO,OT US-UCBSA-104409 Preferred Term Product Role Route Abnormal behaviour VIMPAT S Convulsion KEPPRA S Psychotic disorder PREDNISONE S Sepsis VIGABATRIN S Hypersomnia CLONAZEPAM S Walking disability TOPOMAX S Muscle atrophy ZONEGRAN S Emotional disorder LAMICTAL S Cognitive disorder BANZEL S Sleep terror ACTH S Dosage Text Age Sex Country Female USA Duration Manufacturer Asthenia Crying Decreased appetite Drug ineffective Fall Psychomotor skills impaired Screaming Sleep disorder Status epilepticus Weight increased FDA Received Date 9752315 Case # Case Type Health Professional Outcomes 11-Dec-2013 9752315 DIRECT Y OT Preferred Term Product Role Route Dyspnoea ACTHAR S Manufacturer Control # Dosage Text Age Sex Country 69 YR Female USA Duration Manufacturer SUBCUTANEOUS QUESTCOR FDA Received Date 9752868 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2013 9752868 EXPEDITED (15-DAY) Y HO QSC-2013-0439 26 YR Male USA Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 98 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9752868 Preferred Term Product Role Route Dosage Text Orthostatic hypotension H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S 60 units, BIW Vomiting PREDNISONE C Postural orthostatic tachycardia syndrome MARINOL C Gastrooesophageal reflux disease LANTUS (INSULIN GLARGINE) C Gastrointestinal disorder ZOFRAN (ONDANSETRON) C PHENERGAN (PROMETHAZINE) C DIAMOX (ACETAZOLAMIDE) C CALCIUM & VITAMIN D (CALCIUM, COLECALCIFEROL) C FLEXERIL (CYCLOBENZAPRINE HYDROCHLORIDE) C BENTYL (DICYCLOVERINE HYDROCHLORIDE) C VITAMIN D2 (ERGOCALCIFEROL) C NOVOLOG (INSULIN ASPART) C ATIVAN (LORAZEPAM) C PROTONIX (PANTOPRAZOLE SODIUM SESQUIHYDRATE) C CARAFATE (SUCRALFATE) TABLET, 1G C IMITREX (SUMATRIPTAN) C VENTOLIN (SALBUTAMOL) C ALBUTEROL (SALBUTAMOL SULFATE) C DONNATAL (ATROPINE SULFATE, HYOSCINE HYDROBROMIDE, HYOSCYAMINE SULFATE, PHENOBARBITAL) C ZYRTEC (CETIRIZINE HYDROCHLORIDE) C EPIPEN (EPINEPHRINE) C Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 99 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9752868 Preferred Term Product Role Route GLUCAGON (GLUCAGON) C PROAMATINE (MIDODRINE HYDROCHLORIDE) C LISINOPRIL (LISINOPRIL) C LASIX (FLUROSEMIDE) C Dosage Text Duration Manufacturer Adrenal disorder Autonomic nervous system imbalance Diarrhoea Nausea FDA Received Date 9766353 Case # Case Type Health Professional Outcomes 16-Dec-2013 9766353 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Mood altered ACTHAR GEL S 8 units twice weekly, IM Age Duration Sex Country Female USA Manufacturer QUESTCOR Insomnia Weight increased Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 100 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9781031 Case # Case Type 23-Dec-2013 9781031 DIRECT Preferred Term Health Professional Outcomes Manufacturer Control # HO,DS Product Role Route Dosage Text H.P. ACTHAR S Given into/inder the skin Age Sex Country 49 YR Female USA Duration Manufacturer QUESTCOR Amnesia Asthenia Blood glucose increased Blood pressure increased Dehydration Diarrhoea Disturbance in attention Dizziness Dry eye Dry mouth Eye irritation Fatigue Feeling abnormal Heart rate increased Hyperhidrosis Insomnia Mood swings Myositis Nausea Photosensitivity reaction Psychomotor hyperactivity Thirst Tremor Vision blurred Weight fluctuation Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 101 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9792144 Case # Case Type Health Professional Outcomes 31-Dec-2013 9792144 DIRECT Y OT Preferred Term Product Role Route Drug ineffective ACTHAR S Manufacturer Control # Dosage Text SUBCUTANEOUS Age Sex Country 57 YR Female USA Duration Manufacturer 5 MTH QUESTCOR Kidney transplant rejection FDA Received Date 9802918 Case # Case Type Health Professional Outcomes 06-Jan-2014 9802918 DIRECT Y OT Preferred Term Manufacturer Control # Product Role Route Dosage Text ACTHAR GEL S 80units 2 x weekly Subcutaneous SUBCUTANEOUS Age Sex Country 72 YR Female USA Duration Manufacturer QUESTCOR Abdominal distension Local swelling FDA Received Date 9818043 Case # Case Type Health Professional 13-Jan-2014 9818043 DIRECT Y Outcomes Manufacturer Control # Age Sex Country 51 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Drug ineffective H.P. ACTHAR S 80 units qd x5ds sc 5 DAY QUESTCOR Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Page: 102 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9823314 Case # Case Type Health Professional 16-Jan-2014 9823314 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age HO US-LUNDBECKDKLU1093316 281 DAY Male USA Product Role Route Brain injury Sabril (For Oral Solution) S ORAL LUNDBECK Hypertension Sabril (For Oral Solution) S ORAL LUNDBECK Choreoathetosis Sabril (For Oral Solution) S ORAL Nuclear magnetic resonance imaging abnormal Sabril (For Oral Solution) S ORAL Status epilepticus Sabril (For Oral Solution) S ORAL Respiratory failure Sabril (For Oral Solution) S ORAL Sabril (For Oral Solution) S ORAL ACTH S ACTHAR HP C KEPPRA C PRILOSEC C TYLENOL C ORAL D-VI-SOL C ORAL MIRALAX C Case # Case Type 21-Jan-2014 9840593 DIRECT Health Professional Outcomes Product Role Route Face oedema ACTHAR S Manufacturer 1 TSP Manufacturer Control # OT Preferred Term Duration Country Preferred Term FDA Received Date 9840593 Dosage Text Sex Dosage Text Age Sex Country 40 YR Female USA Duration Manufacturer 3 MTH Pyrexia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 103 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9643254 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 27-Jan-2014 9643254 EXPEDITED (15-DAY) Y HO,OT QSC-2013-0373 182 DAY Female Preferred Term Product Role Route Dosage Text Cardiomyopathy H.P.ACTHAR S unk VIGABATRIN (VIGABATRIN) C DIFLUCAN (FLUCONAZOLE) C OMNICEF (CEFDINIR) C ZANTAC (RANITIDINE HYDROCHLORIDE) C KLONOPIN (CLONAZEPAM) (TABLETS) C FDA Received Date 9852357 Case # Case Type Health Professional Outcomes Manufacturer Control # 27-Jan-2014 9852357 EXPEDITED (15-DAY) Y OT QSC-2014-0040 Preferred Term Product Role Route Brain abscess H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET S Dosage Text Sex Duration Age Country USA Manufacturer Sex Country Unknown USA Duration Manufacturer ORAL FDA Received Date 9852377 Case # Case Type Health Professional Outcomes Manufacturer Control # Age 27-Jan-2014 9852377 EXPEDITED (15-DAY) Y HO QSC-2013-0142 152 DAY Female Preferred Term Product Role Route Dosage Text Medication error H.P. ACTHAR S 80 units, qd for 2 weeks, Intramuscular PRILOSEC (OMEPRAZOLE) C INTRAMUSCULAR Duration Sex Country USA Manufacturer Hypertension Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 104 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9852386 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 27-Jan-2014 9852386 EXPEDITED (15-DAY) Y HO QSC-2012-0314 63 YR Male USA Preferred Term Product Role Route Dosage Text Dyspnoea H.P. ACTHAR GEL S 80 Units, BIW Dyspnoea DIVOAN (VALSARTAN) C (BISOLICH (BISOPROLOL FUMARATE) C GLIMEPIRIDE (GLIMEPIRIDE) C WELLBUTRIN (BUPROPION HYDROCHLORIDE) C Duration Manufacturer Hypertension FDA Received Date 9854850 Case # Case Type Health Professional Outcomes Manufacturer Control # 27-Jan-2014 9854850 EXPEDITED (15-DAY) Y DE QSC-2014-0029 Preferred Term Product Role Route Dosage Text Sepsis H.P. ACTHAR GEL S unk FDA Received Date 9876248 Case # Case Type Health Professional 06-Feb-2014 9876248 NON-EXPEDITED Outcomes Sex Country Unknown USA Duration Manufacturer Manufacturer Control # Age Sex Country US-ACORDAACO_36619_2013 40 YR Female USA Preferred Term Product Role Route Dosage Text Swelling face Ampyra S UNKNOWN 10 mg, Q 12 hrs Local swelling ACTHAR HP S UNKNOWN UNK,UNK Erythema Cyproheptadine HCl C UNKNOWN 4 mg, UNK Hot flush Promethazine C UNKNOWN 25 mg, UNK Imitrex C UNKNOWN 50 mg, UNK Doxepin hcl C UNKNOWN 50 mg, UNK Skelaxin C UNKNOWN 800 mg, UNK Topamax C UNKNOWN 25 mg, UNK Ultram C UNKNOWN 50 mg, UNK Gilenya C UNKNOWN UNK,UNK Zanaflex C Date - Time: 05-05-2014 8:35:59 AM EST Age Duration Manufacturer ACORDA 4 mg, UNK Note: If the field is blank, there is no data Page: 105 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9876467 Case # Case Type Health Professional 06-Feb-2014 9876467 NON-EXPEDITED Outcomes Manufacturer Control # Age US-ACORDAACO_35266_2013 Preferred Term Product Role Route Dosage Text Dry mouth Ampyra S 10 mg, bid ACTHAR HP S FDA Received Date 9885982 Case # Case Type Health Professional 07-Feb-2014 9885982 DIRECT Y SUBCUTANEOUS Outcomes Country Female USA Duration Manufacturer ACORDA 80 ut/ml, qd Manufacturer Control # Age Sex Country 55 YR Female USA Preferred Term Product Role Route Dosage Text Duration Palpitations ACTHAR GEL S Inject 1ml under the skin every 2 weeks for 6 months, Expires in 28 days once opened; 6 MTH SUBCUTANEOUS Sex Manufacturer Dyspnoea FDA Received Date 9886008 Case # Case Type Health Professional 07-Feb-2014 9886008 DIRECT Y Outcomes Manufacturer Control # Age Sex Country 85 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Local swelling H.P. ACTHAR S inject 80 units (1mL) under the skin twice weekly for 6 months. 6 MTH QUESTCOR SUBCUTANEOUS FDA Received Date 9888860 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 07-Feb-2014 9888860 EXPEDITED (15-DAY) Y DE,HO QSC-2014-0034 58 YR Male USA Preferred Term Product Role Route Dosage Text Acute respiratory distress syndrome H.P ACTHAR GEL (ADRENOCORITCOTROPIC HORMONE) GETL FOR INJECTION, 80 U/ML S 80 units, biw, Subcutaneous Respiratory failure MEDROL (METHYLPREDNISOLONE) C Shock PROAIR HFA (SALBUTAMOL SULFATE) C Date - Time: 05-05-2014 8:35:59 AM EST SUBCUTANEOUS Note: If the field is blank, there is no data Duration Manufacturer Page: 106 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9888860 Preferred Term Product Role Route Atrial fibrillation PREDNISONE(PREDNISONE) C FUROSEMIDE(FUROSEMIDE) C Anaemia PROTONIX(PANTOPRAZOLE SODIUM SESQUIHYRATE) C Bundle branch block left ZYRTEC(CETIRIZINE HYDROCHLORIDE) C FERROUS SULFATE(FERROUS SULFATE) C ACETAMINOPHEN (PARACETEMAOL) C CULTURELLE(LACTOBACILLUS NOS) C FOLIC ACID (FOLIC ACID) C MULTIVITMAIN (VITAMINS NOS) C SUPER B COMPLEX (VITAMIN B COMPLEX) C VITAMIN D NOSE (VITAMIN D NOS) C ZITHROMAX(AZITHROMYCIN) C ADVAIR(FLUTICASONE PROPRIONATE, SALMETEROL XINAFOATE) C BENADRYL(DIPHENHYDRAMINE HYDROCHLORIDE) C PREVAGEN C ELOCON CREAM (MOMETASONE FUROATE CREAM) C Dosage Text Duration Manufacturer Extremity necrosis Lactic acidosis Pneumonia aspiration Respiratory arrest Skin necrosis Thrombocytopenia Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 107 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9667605 Case # Case Type Health Professional 13-Feb-2014 9667605 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age HO US-LUNDBECKDKLU1094374 270 DAY Female USA Product Role Route Gastroenteritis Sabril (For Oral Solution) S ORAL LUNDBECK Hypertension Sabril (For Oral Solution) S ORAL LUNDBECK Convulsion Sabril (For Oral Solution) S ORAL Haematuria Sabril (For Oral Solution) S Tympanic membrane perforation ACTH S Irritability TOPAMAX C Somnolence PRELONE C Otitis media acute NORVASC C Upper respiratory tract infection PREDNISOLE C ZONEGRAN C Note: If the field is blank, there is no data Duration Country Preferred Term Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Sex Manufacturer Page: 108 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9915629 Case # Case Type 19-Feb-2014 9915629 DIRECT Health Professional Outcomes Manufacturer Control # DS Age Sex Country 53 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blood glucose increased ACTHAR HP S 400 usp units/5ml (80usp units/ml 1 shot daily for 5 days. 1mL once daily for 5 days subcutaneous injection 5 DAY QUESTCOR METOPROLOL SUCC ER C Vision blurred LOVAZA C Weight increased CITRACAL C Confusional state VIT D C CITOLPRAM C BACLFEN C VITAFUSION MULTI. VIT C VIT. C. C TECFIDER C FUROSEMIDE C FUROSEMIDE C VIT D3 C BENEDRYL C VIPAFUSION MULTI-VITAMINS CHEWABLE 2 GUMMIES C RECLAST C NIACIN C VIT B COMPLETE WITH B12 C SUBCUTANEOUS Back pain Muscle spasms Vaginal haemorrhage Visual impairment Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 109 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9916030 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Feb-2014 9916030 EXPEDITED (15-DAY) Y HO QSC-2014-0087 61 YR Female USA Preferred Term Product Role Route Dosage Text Acute myocardial infarction H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S UNK Duration Manufacturer Anaemia Asthenia Herpes zoster Pneumonia bacterial FDA Received Date 9959411 Case # Case Type 28-Feb-2014 9959411 DIRECT Health Professional Outcomes Manufacturer Control # HO Age Sex Country 75 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Local swelling ACTHAR GEL HP80UNIT/ML 5ML VL QUESTCOR S inject 1 ml (80 units) subcutaneously twice a week for 12 weeks. 12 WEEK QUESTCOR SUBCUTANEOUS Blood pressure increased Dizziness Headache Hypoaesthesia Paraesthesia oral FDA Received Date 9959457 Case # Case Type 28-Feb-2014 9959457 DIRECT Health Professional Outcomes Manufacturer Control # Preferred Term Product Role Route Dosage Text Speech disorder ACTHAR GEL HP80UNIT/ML 5ML VL QUESTCOR PHARM. S subcutaneously twice a week for 6 chronic membranous month SUBCUTANEOUS Age Sex Country 60 YR Female USA Duration Manufacturer QUESTCOR Arthralgia Pain in extremity Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 110 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9971333 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Mar-2014 9971333 EXPEDITED (15-DAY) Y OT QSC-2014-0112 49 YR Female USA Preferred Term Atrial fibrillation Product Role Route H.P ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE), GEL FOR INJECTION, 80U/ML S CANDESARTAN (CANDESARTAN) C FISH OIL (FISH OIL) C NIACIN (NICOTINIC ACID) C ALLEGRA C Dosage Text Duration Manufacturer SUBCUTANEOUS Oedema FDA Received Date 9971472 Case # Case Type 05-Mar-2014 9971472 DIRECT Health Professional Outcomes Manufacturer Control # Preferred Term Product Role Route Dosage Text Insomnia H.P. ACTHAR S 80 ML once daily Given into/Under the skin SUBCUTANEOUS Age Sex Country 422 YR Female USA Duration Manufacturer QUESTCOR Abdominal distension Dyspnoea Local swelling Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 111 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9983447 Case # Case Type Health Professional 07-Mar-2014 9983447 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO,OT US-LUNDBECKDKLU1097930 1 YR Male USA Preferred Term Product Role Route Hypertension Sabril (For Oral Solution) S ORAL LUNDBECK Renal disorder Sabril (For Oral Solution) S ORAL LUNDBECK Gastrointestinal infection Sabril (For Oral Solution) S ORAL Convulsion Sabril (For Oral Solution) S ORAL Clumsiness Sabril (For Oral Solution) S ORAL Dizziness Sabril (For Oral Solution) S ORAL ACTHAR S Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Duration Manufacturer Page: 112 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9994734 Case # Case Type Health Professional Outcomes 07-Mar-2014 9994734 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Adverse drug reaction ACTHAR S previous use unknown, unknown, unknown ALPRAZOLAM C AZITHROMYCIN C CALCITRATE C CHLORDIAZEPOXIDE/AMIT C D-AMPHETAMINE SALTS C DICYCLOMINE C CIPROFLOXACIN C FLUCONAZOLE C LEVOFLOXACIN C LEVOTHYROXINE C METOCLOPRAMIDE C MONTELUKAST C MUPIROCIN 2% OINTIMENT C NITROFURANTOIN MON/MAC C OMEPRAZOLE C OMNARIS C ONDANSETRON ODT C PANTOPRAZOLE C PREDNISONE C PROMETHAZINE C PROPRANOLOL C SUPREP BOWEL PREP SOLUTION C TAMIFLU C Age Duration Sex Country Female USA Manufacturer QUESTCOR Product quality issue Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 113 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9999041 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Mar-2014 9999041 EXPEDITED (15-DAY) Y HO QSC-2014-0101 73 YR Male USA Preferred Term Product Role Route Syncope H.P. ACTHAR GEL S Dosage Text Duration Manufacturer Hiccups FDA Received Date 10011636 Case # Case Type Health Professional Outcomes 13-Mar-2014 10011636 DIRECT Y OT Manufacturer Control # Preferred Term Product Role Route Dosage Text Headache ACTHAR H.P. S 80units/ml Injectable Subcutaneous 057 twice weekly SUBCUTANEOUS Age Sex Country 63 YR Female USA Duration Manufacturer Abdominal pain Wheezing FDA Received Date 10013004 Case # Case Type Health Professional 14-Mar-2014 10013004 NON-EXPEDITED Outcomes Manufacturer Control # Age Sex Country OT US-PFIZER INC-2014071294 36 YR Male USA Preferred Term Product Role Route Dosage Text Fluid retention Lyrica S UNK Dyspnoea CYCLOSPORINE S UNK Muscle twitching H.P ACTHAR GEL S UNK H.P ACTHAR GEL S Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer PFIZER Page: 114 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 10025647 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Mar-2014 10025647 EXPEDITED (15-DAY) Y HO QSC-2014-0133 55 YR Male USA Preferred Term Product Role Route Renal failure acute H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Syncope METOLAZONE (METOLAZONE) C Hypokalaemia LASIX (FUROSEMIDE) C Dehydration METFORMIN (METFORMIN) C Decreased appetite LISINOPRIL (LISINOPRIL) C Dosage Text Duration Manufacturer SUBCUTANEOUS Acute prerenal failure Dysgeusia Fatigue Renal failure acute FDA Received Date 10022179 Case # Case Type 18-Mar-2014 10022179 DIRECT Health Professional Outcomes Manufacturer Control # OT Preferred Term Product Role Route Dosage Text Underdose ACTHAR H.P. S 80u/ml oral 047 twice weekly No adverse event PREDNISONE C ARAVA C TRILEPTAL C ORAL Age Sex Country 34 YR Female USA Duration Manufacturer Wrong technique in drug usage process FDA Received Date 10029784 Case # Case Type Health Professional 19-Mar-2014 10029784 EXPEDITED (15-DAY) Outcomes Manufacturer Control # HO QSC-2014-0143 Preferred Term Product Role Route Renal failure H.P. ACTHAR GEL S Dosage Text Age Duration Sex Country Female USA Manufacturer SUBCUTANEOUS Dialysis Oedema Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 115 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9999039 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Mar-2014 9999039 EXPEDITED (15-DAY) Y OT QSC-2014-0124 26 YR Female USA Preferred Term Product Role Route Dosage Text Central nervous system lesion H.P. ACTHAR GEL S unk, 10 days DIMETHYL FUMARATE C SUBCUTANEOUS Duration Manufacturer Paraesthesia FDA Received Date 10029837 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 20-Mar-2014 10029837 EXPEDITED (15-DAY) Y HO QSC-2014-0142 23 YR Male USA Preferred Term Product Role Route Dehydration H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Duration Manufacturer Blood creatinine increased Nausea Vomiting FDA Received Date 10027909 Case # Case Type Health Professional 21-Mar-2014 10027909 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country OT US-SA-2013SA103272 36 YR Female USA Preferred Term Product Role Route Abasia AUBAGIO S ORAL Hot flush ACTHAR S UNKNOWN Dosage Text Duration Manufacturer Alopecia Multiple sclerosis relapse Pain in extremity Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 116 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 10039409 Case # Case Type Health Professional 26-Mar-2014 10039409 EXPEDITED (15-DAY) Outcomes Manufacturer Control # OT PHHY2014US036042 Preferred Term Product Role Route Neuromyelitis optica MYCOPHENOLATE S Drug ineffective AZATHIOPRINE S GLATIRAMER ACETATE S INTERFERONS S ACTH S RITUXIMAB S MITOXANTRONE C FDA Received Date 10040894 Case # Case Type Health Professional 27-Mar-2014 10040894 NON-EXPEDITED Dosage Text Age Sex Country Female USA Duration Manufacturer NOVARTIS Outcomes Manufacturer Control # Age Sex Country OT US-PFIZER INC-2014085285 79 YR Male USA Preferred Term Product Role Route Dosage Text Drug hypersensitivity ERYTHROMYCIN S UNK PFIZER TRIMETHOPRIM S UNK UNKNOWN PHENOBARBITAL S UNK ACTH S UNK DRIXORAL S UNK FLURAZEPAM HYDROCHLORIDE S DICYCLOVERINE HYDROCHLORIDE S CHLORPHENAMINE W/ PHENYLPROPANOLAMINE S Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Duration Manufacturer Page: 117 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 10048409 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 27-Mar-2014 10048409 EXPEDITED (15-DAY) Y DE QSC-2014-0141 67 YR Male USA Preferred Term Product Role Route Sudden death H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Duration Manufacturer SUBCUTANEOUS Abdominal pain Fluid retention FDA Received Date 10056129 Case # Case Type Health Professional 01-Apr-2014 10056129 EXPEDITED (15-DAY) Outcomes Manufacturer Control # Age Sex Country HO QSC-2014-0179 48 YR Male USA Preferred Term Product Role Route Incorrect route of drug administration H.P. ACTHAR GEL S Dosage Text Duration Manufacturer Anxiety Heart rate increased FDA Received Date 10056142 Case # Case Type Health Professional Outcomes Manufacturer Control # 01-Apr-2014 10056142 EXPEDITED (15-DAY) Y HO QSC-2014-0187 Preferred Term Product Role Route Sepsis H.P. ACTHAR GEL S RITUXAN (RITUXIMAB) C IMMUNOGLOBULIN (IMMUNOGLOBULINS NOS) C METHOTREXATE (METHOTREXATE) C PREDNISONE (PREDNISONE) C CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) C Date - Time: 05-05-2014 8:35:59 AM EST Dosage Text Note: If the field is blank, there is no data Age Duration Sex Country Female USA Manufacturer Page: 118 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 10072553 Case # Case Type Health Professional Outcomes Manufacturer Control # 09-Apr-2014 10072553 EXPEDITED (15-DAY) Y HO QSC-2014-0212 Preferred Term Product Role Route Diabetic ketoacidosis H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Age Sex Country Male USA Duration Manufacturer FDA Received Date 9845585 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Apr-2014 9845585 EXPEDITED (15-DAY) Y HO QSC-2014-0011 29 YR Female USA Preferred Term Product Role Route Haemoglobin decreased H.P. ACTHAR GEL S Heart rate increased CYMBALTA (DULOXETNE HYDROCHLORIDE) C Haematochezia METHOTREXATE (METHOTREXATE) C Dyspnoea FOLIC ACID (FOLIC ACID) C Dosage Text Duration Manufacturer Abdominal pain Anaemia Gastrointestinal haemorrhage Pain Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 119 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 9971318 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Apr-2014 9971318 EXPEDITED (15-DAY) Y OT QSC-2014-0106 12 YR Female USA Preferred Term Product Role Route Tachycardia H.P. ACTHAR GEL S Toxicity to various agents MEDROL (METHYLPREDNISOLONE ACETATE) C SOLUMEDROL (METHYLPREDNISOLONE SODIUM) C VORICONAZOLE (VORICONAZOLE) C VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) (VALGANCICLOVIR HYDROCHLORIDE) C Dosage Text Duration Manufacturer SUBCUTANEOUS Drug interaction FDA Received Date 10085726 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Apr-2014 10085726 EXPEDITED (15-DAY) Y HO QSC-2014-0232 54 YR Male USA Preferred Term Product Role Route Renal failure H.P. ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) GEL FOR INJECTION, 80U/ML S Dosage Text Duration Manufacturer SUBCUTANEOUS Drug effect incomplete Fluid overload Fluid retention Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 120 of 121 FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report FDA Received Date 10086295 Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Apr-2014 10086295 EXPEDITED (15-DAY) Y DE,HO QSC-2014-0233 54 YR Male USA Preferred Term Product Role Route Cardiac failure H.P ACTHAR GEL S Dosage Text Duration Manufacturer Pneumonia Weight increased Date - Time: 05-05-2014 8:35:59 AM EST Note: If the field is blank, there is no data Page: 121 of 121