FDA Adverse Event Reporting System: Harvoni

Jun 16, 2015 | Publisher: Jack | Category: Science |  

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Product Name: .;HARVONI Product Active Ingredient: . FDA Received Date: From: 10-OCT-2014 Total Cases**: 759 Number of Pages: 216 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. Detailed Report To: 15-MAR-2015 *. “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. MedDRA® Version* : 17.1 Selection Criteria: Active Ingredient . . Active Moiety: Page: 1 of 216 Date - Time: 03-24-2015 4:12:15 PM EST FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 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. Manufacturer Control # The Manufacturer Control Number is the manufacturer’s unique identifier associated with the case. Also referred to as the Company Report Number. Age The patient's age, with age unit, based on information provided in the report. Sex Patient sex (Male, Female, Unknown). Country 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. 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. Page: 2 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report Field Heading Definition Preferred Term 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 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. Role 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. Route 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. Page: 3 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10555873 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 30-Oct-2014 10555873 EXPEDITED (15-DAY) OT US- GILEAD-2014-0120484 70 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Swelling face HARVONI S UNKNOWN UNK GILEAD VIBRANCE GREEN C PLANT FUSION WITH PROTEIN POWDER C MORINGA C SEA VEG C 10564309 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Nov-2014 10564309 EXPEDITED (15-DAY) US- GILEAD-2014-0120470 60 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Dyspepsia HARVONI S UNKNOWN UNK GILEAD 10567735 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Nov-2014 10567735 DIRECT Y 49 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S ORAL by mouth GILEAD 10569133 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 06-Nov-2014 10569133 EXPEDITED (15-DAY) US- GILEAD-2014-0121190 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Gastrointestinal motility disorder HARVONI S UNKNOWN GILEAD Page: 4 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10574244 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Nov-2014 10574244 EXPEDITED (15-DAY) US- GILEAD-2014-0121768 61 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Erythema HARVONI S UNKNOWN UNK GILEAD Pruritus 10574606 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Nov-2014 10574606 EXPEDITED (15-DAY) US- GILEAD-2014-0122062 51 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN GILEAD Abdominal discomfort Diarrhoea Nausea 10577680 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Nov-2014 10577680 EXPEDITED (15-DAY) US- GILEAD-2014-0122164 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN GILEAD TRUVADA C GILEAD TIVICAY C 10580238 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Nov-2014 10580238 EXPEDITED (15-DAY) US- GILEAD-2014-0122382 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Lymphadenopathy HARVONI S UNKNOWN GILEAD Blister Lymphadenopathy Page: 5 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10582222 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 13-Nov-2014 10582222 EXPEDITED (15-DAY) US- GILEAD-2014-0121897 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nasopharyngitis HARVONI S UNKNOWN GILEAD Abdominal discomfort Poor quality sleep 10582315 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 13-Nov-2014 10582315 EXPEDITED (15-DAY) US- GILEAD-2014-0122431 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Dyspepsia HARVONI S UNKNOWN GILEAD ADCIRCA C SPIRONOLACTONE C 10582504 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 13-Nov-2014 10582504 EXPEDITED (15-DAY) OT US- GILEAD-2014-0122112 67 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Renal failure acute HARVONI S UNKNOWN UNK GILEAD Presyncope PLAVIX C Dehydration COLCHICINE C UNK, BID Diarrhoea ULORIC C Dysphagia METOPROLOL C Sensation of foreign body LIPITOR C Chest pain ASPIRIN / 00002701/ C 81 mg, UNK Vomiting ESOMEPRAZOLE C Page: 6 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10584733 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Nov-2014 10584733 EXPEDITED (15-DAY) US- GILEAD-2014-0122459 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Off label use HARVONI S UNKNOWN GILEAD 10585030 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Nov-2014 10585030 EXPEDITED (15-DAY) US- GILEAD-2014-0122564 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Protein urine present HARVONI S UNKNOWN GILEAD Urine protein/creatinine ratio increased 10585940 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 14-Nov-2014 10585940 EXPEDITED (15-DAY) US- GILEAD-2014-0122925 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hot flush HARVONI S UNKNOWN UNK GILEAD 10587619 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Nov-2014 10587619 EXPEDITED (15-DAY) US- GILEAD-2014-0122993 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Gastrointestinal sounds abnormal HARVONI S UNKNOWN GILEAD Diarrhoea Fatigue Headache Page: 7 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10588065 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Nov-2014 10588065 EXPEDITED (15-DAY) US- GILEAD-2014-0122913 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Vitreous floaters HARVONI S UNKNOWN UNK GILEAD 10588079 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Nov-2014 10588079 EXPEDITED (15-DAY) US- GILEAD-2014-0122982 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Vomiting HARVONI S UNKNOWN GILEAD Abdominal pain Influenza like illness 10591545 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Nov-2014 10591545 EXPEDITED (15-DAY) US- GILEAD-2014-0123020 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S UNKNOWN UNK GILEAD Abdominal discomfort 10595171 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Nov-2014 10595171 DIRECT Y 61 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Depression HARVONI S ORAL GILEAD Back pain Feeling abnormal Pain Page: 8 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10596714 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 20-Nov-2014 10596714 EXPEDITED (15-DAY) US- GILEAD-2014-0123522 67 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nail infection HARVONI S UNKNOWN GILEAD 10596782 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 20-Nov-2014 10596782 EXPEDITED (15-DAY) HO,OT US- GILEAD-2014-0123538 58 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Cardiac failure congestive HARVONI S UNKNOWN UNK GILEAD 10599901 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Nov-2014 10599901 EXPEDITED (15-DAY) US- GILEAD-2014-0123398 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Drug dose omission HARVONI S UNKNOWN GILEAD 10599930 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Nov-2014 10599930 EXPEDITED (15-DAY) US- GILEAD-2014-0123613 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Gastric disorder HARVONI S UNKNOWN GILEAD 10599932 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Nov-2014 10599932 EXPEDITED (15-DAY) US- GILEAD-2014-0123668 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Ear infection HARVONI S UNKNOWN GILEAD Page: 9 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10599933 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 21-Nov-2014 10599933 EXPEDITED (15-DAY) US- GILEAD-2014-0123685 69 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S UNKNOWN GILEAD Diarrhoea METFORMIN C 10603181 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Nov-2014 10603181 EXPEDITED (15-DAY) US- GILEAD-2014-0123622 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Palpitations HARVONI S UNKNOWN GILEAD 10603283 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Nov-2014 10603283 EXPEDITED (15-DAY) US- GILEAD-2014-0123630 68 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Muscle spasms HARVONI S UNKNOWN UNK GILEAD Diarrhoea 10603286 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Nov-2014 10603286 EXPEDITED (15-DAY) US- GILEAD-2014-0123837 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Overdose HARVONI S UNKNOWN 2 DF, QD GILEAD HARVONI S UNKNOWN 1 DF, UNK GILEAD Page: 10 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10603290 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Nov-2014 10603290 EXPEDITED (15-DAY) OT US- GILEAD-2014-0123734 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Suicidal ideation HARVONI S UNKNOWN GILEAD Diarrhoea Insomnia Migraine Pain Phantom pain Retching Unevaluable event 10606830 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Nov-2014 10606830 DIRECT 59 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL GILEAD Diarrhoea Page: 11 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10615690 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 25-Nov-2014 10615690 DIRECT Y HO 51 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S ORAL 1 QD Oral GILEAD METFORMIN C OMPERAZOLE C GLYBURIDE C DICYCLOMINE C LYRICA C BUPRENORPHINE C VITAMIN B1 C AMLODIPINE C Vomiting 10611592 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 26-Nov-2014 10611592 EXPEDITED (15-DAY) US- GILEAD-2014-0124327 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S UNKNOWN UNK GILEAD 10617853 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 01-Dec-2014 10617853 EXPEDITED (15-DAY) US- GILEAD-2014-0124412 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Insomnia HARVONI S UNKNOWN UNK GILEAD Page: 12 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10620623 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Dec-2014 10620623 EXPEDITED (15-DAY) HO,OT US- GILEAD-2014-0124551 50 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pancreatitis HARVONI S UNKNOWN GILEAD Chest pain Paraesthesia oral 10620628 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Dec-2014 10620628 EXPEDITED (15-DAY) US- GILEAD-2014-0124462 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Joint swelling HARVONI S UNKNOWN UNK GILEAD Fatigue ATENOLOL C AMBIEN C D3 C MULTIVITAMINS C ALA /00213801/ C 10622428 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Dec-2014 10622428 DIRECT Y Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Vaginal odour HARVONI S ORAL GILEAD Vaginal discharge Vaginal infection 10622456 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Dec-2014 10622456 DIRECT Y 80 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Visual impairment HARVONI S ORAL 1 tablet GILEAD Blood pressure increased Hearing impaired Page: 13 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10622475 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Dec-2014 10622475 DIRECT Y 57 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 TABLET DAILY PO GILEAD Depression Fatigue 10588049 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10588049 EXPEDITED (15-DAY) US- GILEAD-2014-0122699 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Bone pain HARVONI S UNKNOWN UNK GILEAD Abdominal discomfort Diarrhoea Headache Pain Vision blurred 10623275 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10623275 EXPEDITED (15-DAY) US- GILEAD-2014-0124798 61 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nausea HARVONI S ORAL 1 DF, QD GILEAD Fatigue 10623279 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10623279 EXPEDITED (15-DAY) US- GILEAD-2014-0124725 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pruritus generalised HARVONI S UNKNOWN UNK GILEAD Fatigue Page: 14 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10623292 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10623292 EXPEDITED (15-DAY) OT US- GILEAD-2014-0125129 59 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pancytopenia HARVONI S UNKNOWN UNK GILEAD 10623359 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10623359 EXPEDITED (15-DAY) US- GILEAD-2014-0124754 75 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Drug dose omission HARVONI S UNKNOWN GILEAD 10636192 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 03-Dec-2014 10636192 DIRECT Y 62 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Abnormal dreams HARVONI S ORAL GILEAD Somnolence 10627291 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 04-Dec-2014 10627291 EXPEDITED (15-DAY) US- GILEAD-2014-0125103 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Balance disorder HARVONI S UNKNOWN UNK GILEAD Feeling abnormal 10636131 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636131 EXPEDITED (15-DAY) US- GILEAD-2014-0125282 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blood creatinine increased HARVONI S UNKNOWN UNK GILEAD Glomerular filtration rate decreased Page: 15 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10636133 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636133 EXPEDITED (15-DAY) US- GILEAD-2014-0125275 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Increased appetite HARVONI S UNKNOWN 1 DF, UNK GILEAD Feeling cold Hypoglycaemia 10636146 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636146 EXPEDITED (15-DAY) HO US- GILEAD-2014-0125102 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Chest pain HARVONI S UNKNOWN GILEAD Dyspnoea Headache Weight decreased 10636150 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636150 EXPEDITED (15-DAY) US- GILEAD-2014-0125482 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN GILEAD 10636151 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636151 EXPEDITED (15-DAY) US- GILEAD-2014-0125488 60 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD Page: 16 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10636153 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Dec-2014 10636153 EXPEDITED (15-DAY) OT US- GILEAD-2014-0125677 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Lung infection HARVONI S UNKNOWN UNK GILEAD Sputum discoloured 10641134 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Dec-2014 10641134 DIRECT Y 58 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Chest pain HARVONI S ORAL HARVONI 90-400 MG DAILY PO GILEAD Abdominal distension Chest discomfort Decreased appetite Dyspnoea Psychomotor hyperactivity 10641994 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Dec-2014 10641994 EXPEDITED (15-DAY) US- GILEAD-2014-0125400 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN UNK GILEAD 10641995 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Dec-2014 10641995 EXPEDITED (15-DAY) US- GILEAD-2014-0125483 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S UNKNOWN UNK GILEAD Drug dose omission Page: 17 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10641997 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Dec-2014 10641997 EXPEDITED (15-DAY) US- GILEAD-2014-0125493 62 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nasopharyngitis HARVONI S UNKNOWN UNK GILEAD 10641998 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Dec-2014 10641998 EXPEDITED (15-DAY) US- GILEAD-2014-0125902 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Dyspepsia HARVONI S UNKNOWN UNK GILEAD Diarrhoea Headache 10643191 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 09-Dec-2014 10643191 DIRECT Y 80 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Alopecia HARVONI S ORAL GILEAD 10643497 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Dec-2014 10643497 EXPEDITED (15-DAY) OT DE- GILEAD-2014-0124918 Female DEU Preferred Term Product Role Route Dosage Text Duration Manufacturer Angioedema HARVONI S UNKNOWN 1 DF, UNK GILEAD 10644615 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Dec-2014 10644615 EXPEDITED (15-DAY) US- GILEAD-2014-0125989 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Viral infection HARVONI S UNKNOWN GILEAD Page: 18 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10644991 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 10-Dec-2014 10644991 DIRECT Y 51 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Neuropathy peripheral HARVONI S ORAL 1, daily, po GILEAD Disease recurrence Fibrosis 10646827 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10646827 EXPEDITED (15-DAY) US- GILEAD-2014-0126179 82 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hot flush HARVONI S UNKNOWN UNK GILEAD Rash Page: 19 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10646857 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10646857 EXPEDITED (15-DAY) OT US- GILEAD-2014-0126042 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Ascites HARVONI S ORAL UNK, QD GILEAD Back pain LACTULOSE C Asthenopia Blood glucose decreased Blood pressure fluctuation Dysarthria Fatigue Feeling abnormal Headache Hunger Hypoglycaemia Insomnia Joint stiffness Muscle spasms Peripheral swelling Speech disorder Yellow skin 10646866 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10646866 EXPEDITED (15-DAY) US- GILEAD-2014-0126189 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Chills HARVONI S UNKNOWN GILEAD Pyrexia Page: 20 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10646891 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10646891 EXPEDITED (15-DAY) US- GILEAD-2014-0126255 58 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Insomnia HARVONI S UNKNOWN GILEAD Headache 10647564 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10647564 EXPEDITED (15-DAY) OT US- GILEAD-2014-0126408 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hepatic failure HARVONI S UNKNOWN UNK GILEAD Abdominal pain Abdominal rigidity Bladder pain Chest pain Congenital cystic kidney disease Diarrhoea Fatigue Headache Paraesthesia Peripheral swelling Platelet count abnormal Splenomegaly Vasodilatation 10647597 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 11-Dec-2014 10647597 EXPEDITED (15-DAY) US- GILEAD-2014-0126199 59 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Influenza like illness HARVONI S UNKNOWN UNK GILEAD Vomiting Page: 21 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10651558 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 12-Dec-2014 10651558 DIRECT Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hypersensitivity HARVONI S ORAL GILEAD Eye discharge Eye pruritus 10653039 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653039 EXPEDITED (15-DAY) US- GILEAD-2014-0126301 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Myalgia HARVONI S UNKNOWN UNK GILEAD Back pain Fatigue 10653196 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653196 EXPEDITED (15-DAY) US- GILEAD-2014-0126500 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Off label use HARVONI S UNKNOWN UNK GILEAD PRILOSEC / 00661201/ C UNKNOWN UNK 10653198 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653198 EXPEDITED (15-DAY) US- GILEAD-2014-0126272 49 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Mood swings HARVONI S UNKNOWN 1 DF, UNK GILEAD Anxiety Insomnia Page: 22 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10653245 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653245 EXPEDITED (15-DAY) OT US- GILEAD-2014-0127263 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Cognitive disorder HARVONI S UNKNOWN GILEAD 10653267 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653267 EXPEDITED (15-DAY) US- GILEAD-2014-0126176 57 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Rash HARVONI S ORAL 1 DF, QD GILEAD 10653296 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 15-Dec-2014 10653296 EXPEDITED (15-DAY) OT US- GILEAD-2014-0127261 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Cognitive disorder HARVONI S UNKNOWN GILEAD 10599334 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10599334 EXPEDITED (15-DAY) US- GILEAD-2014-0123390 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Gastrooesophageal reflux disease HARVONI S ORAL 1 DF, QD GILEAD Headache PROTONIX C 40 mg, QD AMBIEN C 10 mg, QHS VALIUM C 15 mg, QHS CLONIDINE C 0.2 mg, BID ZOLOFT C 50 mg, QD METOPROLOL TARTRATE C 50 mg, BID OXYCONTIN C 40 mg, BID OXYCODONE C 30 mg, Q4Hr Page: 23 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10656489 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10656489 EXPEDITED (15-DAY) US- GILEAD-2014-0127197 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Insomnia HARVONI S UNKNOWN GILEAD 10656518 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10656518 EXPEDITED (15-DAY) US- GILEAD-2014-0127255 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S UNKNOWN UNK GILEAD 10656524 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10656524 EXPEDITED (15-DAY) US- GILEAD-2014-0127391 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Migraine HARVONI S UNKNOWN GILEAD Vomiting 10656563 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10656563 EXPEDITED (15-DAY) OT US- GILEAD-2014-0127353 44 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Sepsis HARVONI S UNKNOWN UNK GILEAD 10658854 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10658854 DIRECT HO Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Alopecia HARVONI S E PIVIR HBV C HARVONI C Page: 24 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10659156 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 16-Dec-2014 10659156 DIRECT OT 63 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Dizziness postural HARVONI S ORAL GILEAD Headache 10659483 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10659483 EXPEDITED (15-DAY) US- GILEAD-2014-0127233 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN UNK GILEAD 10659536 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10659536 EXPEDITED (15-DAY) US- GILEAD-2014-0127495 59 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blister HARVONI S ORAL 1 DF, QD GILEAD Rash Rash pustular 10660550 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10660550 EXPEDITED (15-DAY) US- GILEAD-2014-0127561 63 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Urinary tract infection HARVONI S UNKNOWN UNK GILEAD Page: 25 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10660611 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10660611 EXPEDITED (15-DAY) US- GILEAD-2014-0127708 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Neuropathy peripheral HARVONI S UNKNOWN UNK GILEAD Pruritus Rash 10661419 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10661419 DIRECT Y 62 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hallucination, visual HARVONI S ORAL 1 tablet, QD, Oral GILEAD 10661488 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 17-Dec-2014 10661488 DIRECT Y 63 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL one tablet, QD, Oral APAP C IMITREX C No therapeutic response 10599907 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Dec-2014 10599907 EXPEDITED (15-DAY) US- GILEAD-2014-0123542 63 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Arthralgia HARVONI S UNKNOWN UNK GILEAD ATENOLOL CHLORTHALIDONE C ORAL 1 DF, UNK Page: 26 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10662829 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Dec-2014 10662829 EXPEDITED (15-DAY) US- GILEAD-2014-0126318 62 YR Unknown USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Urticaria HARVONI S UNKNOWN GILEAD Rash 10663302 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Dec-2014 10663302 EXPEDITED (15-DAY) US- GILEAD-2014-0127797 62 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Bronchitis HARVONI S UNKNOWN UNK GILEAD Influenza 10663305 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Dec-2014 10663305 EXPEDITED (15-DAY) US- GILEAD-2014-0127887 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Abdominal pain lower HARVONI S UNKNOWN UNK GILEAD 10663307 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 18-Dec-2014 10663307 EXPEDITED (15-DAY) US- GILEAD-2014-0128091 62 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD Page: 27 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10666221 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Dec-2014 10666221 EXPEDITED (15-DAY) HO,OT US- GILEAD-2014-0127533 65 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Clostridium difficile colitis HARVONI S UNKNOWN UNK GILEAD LISINOPRIL C UNKNOWN 20 mg, QD TOPROL C UNKNOWN 100 mg, QD NEURONTIN C UNKNOWN 300 mg, BID TRIAMTERENE AND HYDROCHLOROTHIAZID C UNKNOWN 1 DF, QD LANTUS C 30 units, QD LIPITOR C ORAL 10 mg, QHS PRILOSEC / 00661201/ C UNKNOWN UNK, QD RESTASIS C UNKNOWN gtts, QD OSCAL D / 07451701/ C UNKNOWN UNK ASA C UNKNOWN 81 mg, QD GABAPENTIN C 10667241 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Dec-2014 10667241 DIRECT OT 60 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Chest pain HARVONI S ORAL 1 tablet daily by mouth GILEAD Dyspnoea Pain Page: 28 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10668065 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 19-Dec-2014 10668065 DIRECT OT 57 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blood glucose increased HARVONI S ORAL 1 tab GILEAD METFORMIN C LISINOPRIL C 10603282 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10603282 EXPEDITED (15-DAY) US- GILEAD-2014-0123620 57 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Abnormal dreams HARVONI S ORAL 1 DF, QD GILEAD Headache Insomnia 10620625 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10620625 EXPEDITED (15-DAY) US- GILEAD-2014-0124433 52 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN UNK GILEAD 10642000 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10642000 EXPEDITED (15-DAY) US- GILEAD-2014-0125829 58 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD Drug dose omission Page: 29 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10669941 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10669941 EXPEDITED (15-DAY) US- GILEAD-2014-0128010 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S UNKNOWN UNK GILEAD Eye pain 10669951 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10669951 EXPEDITED (15-DAY) US- GILEAD-2014-0127984 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pollakiuria HARVONI S UNKNOWN UNK GILEAD 10671699 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10671699 EXPEDITED (15-DAY) US- GILEAD-2014-0128412 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S ORAL 1 DF, QD GILEAD Dyspnoea Headache 10671720 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10671720 EXPEDITED (15-DAY) US- GILEAD-2014-0128449 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Loss of libido HARVONI S UNKNOWN UNK GILEAD Fatigue Page: 30 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10673094 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 23-Dec-2014 10673094 EXPEDITED (15-DAY) US- GILEAD-2014-0128282 50 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD 10679010 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 24-Dec-2014 10679010 DIRECT Y HO 70 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Abdominal distension HARVONI S ORAL 1 tablet once daily by mouth GILEAD 10682900 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Dec-2014 10682900 DIRECT 59 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Influenza HARVONI S ORAL One Tablet Chills Cough Headache Pyrexia Page: 31 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10682921 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 29-Dec-2014 10682921 DIRECT Y OT 68 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 Tablet GILEAD Chest pain CERTIRIZINE C DILTIAZEM C DORZOLAMIDE C FINASTERIDE C LEVOTHYROXINE C LISINOPRIL C OXYCODONE C TIMOLOL C WARFARIN C Blood pressure increased 10685425 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 30-Dec-2014 10685425 DIRECT 64 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL GILEAD Fatigue 10685667 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 31-Dec-2014 10685667 EXPEDITED (15-DAY) HO US- GILEAD-2014-0128129 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Anxiety HARVONI S UNKNOWN UNK GILEAD Page: 32 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10685969 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 31-Dec-2014 10685969 EXPEDITED (15-DAY) US- GILEAD-2014-0127574 62 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nausea HARVONI S UNKNOWN 1 DF, UNK GILEAD Fatigue Headache 10687524 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 31-Dec-2014 10687524 DIRECT 57 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S ORAL 90-400, daily, po GILEAD Influenza like illness RIBAVIRIN C SOVALDI C Diarrhoea Headache 10687592 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 31-Dec-2014 10687592 DIRECT Y 37 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S ORAL one tablet Amenorrhoea 10687969 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 31-Dec-2014 10687969 DIRECT Y 56 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S ORAL 1 tablet (400mg/90mg) daily po GILEAD Chills Headache Hyperhidrosis Page: 33 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10620644 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10620644 EXPEDITED (15-DAY) US- GILEAD-2014-0124563 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Drug screen positive HARVONI S UNKNOWN UNK GILEAD 10636118 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10636118 EXPEDITED (15-DAY) US- GILEAD-2014-0125284 84 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Overdose HARVONI S ORAL 24 DF, UNK GILEAD HARVONI S ORAL 1 DF, QD GILEAD 10653077 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10653077 EXPEDITED (15-DAY) US- GILEAD-2014-0127123 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Nasopharyngitis HARVONI S UNKNOWN GILEAD Cough WELLBUTRIN C Dysphonia Vomiting 10688296 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688296 EXPEDITED (15-DAY) US- GILEAD-2014-0128477 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pollakiuria HARVONI S UNKNOWN UNK GILEAD Page: 34 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10688302 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688302 EXPEDITED (15-DAY) US- GILEAD-2014-0128660 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Musculoskeletal pain HARVONI S UNKNOWN GILEAD Arthralgia Headache Myalgia 10688313 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688313 EXPEDITED (15-DAY) US- GILEAD-2014-0128367 58 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Furuncle HARVONI S ORAL 1 DF, QD GILEAD Depression Fatigue Nausea 10688315 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688315 EXPEDITED (15-DAY) US- GILEAD-2014-0128371 51 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD TRAMADOL C Page: 35 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10688322 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688322 EXPEDITED (15-DAY) US- GILEAD-2014-0128428 54 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Diarrhoea HARVONI S ORAL 1 DF, QD GILEAD Depression Fatigue Headache 10688325 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688325 EXPEDITED (15-DAY) US- GILEAD-2014-0128452 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Vomiting HARVONI S UNKNOWN UNK GILEAD 10688326 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688326 EXPEDITED (15-DAY) US- GILEAD-2014-0128467 57 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S ORAL 1 DF, QD GILEAD Anxiety Headache 10688354 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688354 EXPEDITED (15-DAY) US- GILEAD-2014-0128542 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Energy increased HARVONI S UNKNOWN UNK GILEAD Page: 36 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10688355 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688355 EXPEDITED (15-DAY) US- GILEAD-2014-0128652 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Arthropod bite HARVONI S UNKNOWN GILEAD 10688358 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688358 EXPEDITED (15-DAY) US- GILEAD-2014-0128655 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Constipation HARVONI S UNKNOWN GILEAD 10688359 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 02-Jan-2015 10688359 EXPEDITED (15-DAY) US- GILEAD-2014-0128654 57 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blood glucose increased HARVONI S UNKNOWN UNK GILEAD 10691704 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691704 EXPEDITED (15-DAY) US- GILEAD-2014-0128820 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hepatitis C RNA HARVONI S UNKNOWN UNK GILEAD 10691705 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691705 EXPEDITED (15-DAY) US- GILEAD-2014-0128892 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Eye discharge HARVONI S UNKNOWN UNK GILEAD Skin lesion Page: 37 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10691708 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691708 EXPEDITED (15-DAY) US- GILEAD-2014-0129262 58 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Influenza HARVONI S UNKNOWN 1 DF, QD GILEAD Chills Cough Headache Pyrexia 10691710 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691710 EXPEDITED (15-DAY) US- GILEAD-2014-0129059 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pain HARVONI S ORAL UNK GILEAD 10691712 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691712 EXPEDITED (15-DAY) US- GILEAD-2014-0128967 Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Hot flush HARVONI S UNKNOWN UNK GILEAD Nausea 10691713 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691713 EXPEDITED (15-DAY) US- GILEAD-2014-0128965 63 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Influenza HARVONI S UNKNOWN GILEAD Nausea Vomiting Page: 38 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10691714 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691714 EXPEDITED (15-DAY) US- GILEAD-2014-0128917 59 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Insomnia HARVONI S ORAL 1 DF, QD GILEAD 10691715 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691715 EXPEDITED (15-DAY) US- GILEAD-2014-0129163 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Aspartate aminotransferase increased HARVONI S UNKNOWN UNK GILEAD Alanine aminotransferase increased 10691717 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691717 EXPEDITED (15-DAY) US- GILEAD-2014-0129726 47 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Agitation HARVONI S ORAL 1 DF, QD GILEAD Anxiety Fatigue Insomnia Poor quality sleep 10691721 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691721 EXPEDITED (15-DAY) US- GILEAD-2014-0129853 37 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Menstruation irregular HARVONI S UNKNOWN 1 DF, QD GILEAD Diarrhoea Page: 39 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10691722 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691722 EXPEDITED (15-DAY) US- GILEAD-2014-0129765 56 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Oropharyngeal pain HARVONI S ORAL 1 DF, QD GILEAD Headache 10691723 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691723 EXPEDITED (15-DAY) US- GILEAD-2014-0129782 47 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Gastroenteritis viral HARVONI S ORAL 1 DF, QD GILEAD Fatigue Insomnia Nausea 10691725 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691725 EXPEDITED (15-DAY) US- GILEAD-2014-0129829 54 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Irritable bowel syndrome HARVONI S UNKNOWN UNK GILEAD Diarrhoea Dysgeusia Dyspepsia Stomatitis 10691726 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10691726 EXPEDITED (15-DAY) US- GILEAD-2015-0130142 58 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Pruritus generalised HARVONI S UNKNOWN 1 DF, QD GILEAD Page: 40 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10692674 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 05-Jan-2015 10692674 DIRECT OT 58 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Blood urine present HARVONI S ORAL GILEAD Nephrolithiasis 10695099 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 06-Jan-2015 10695099 DIRECT Y HO 61 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Chest pain HARVONI S ORAL one tablet GILEAD Hypertension 10697365 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 07-Jan-2015 10697365 DIRECT Y OT 60 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Swelling face HARVONI S ORAL 1 tablet daily po GILEAD Dyspnoea Muscular weakness 10699158 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699158 EXPEDITED (15-DAY) US- GILEAD-2014-0129933 59 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Fatigue HARVONI S ORAL 1 DF, QD GILEAD Diarrhoea Headache Page: 41 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10699159 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699159 EXPEDITED (15-DAY) US- GILEAD-2015-0130341 Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Accidental exposure to product HARVONI S UNKNOWN UNK GILEAD 10699160 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699160 EXPEDITED (15-DAY) US- GILEAD-2015-0130343 54 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Somnolence HARVONI S ORAL 1 DF, QD GILEAD Pruritus PROPRANOLOL C XANAX C PRISTIQ C ALDACTONE / 00006201/ C CHANTIX C OMEPRAZOLE C 10699164 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699164 EXPEDITED (15-DAY) US- GILEAD-2015-0130363 54 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Headache HARVONI S ORAL 1 DF, QD GILEAD Page: 42 of 216 Date - Time: 03-24-2015 4:12:15 PM EST Note: If the field is blank, there is no data FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 10699209 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699209 EXPEDITED (15-DAY) HO,OT US- GILEAD-2015-0130012 50 YR Male USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Haematemesis HARVONI S UNKNOWN UNK GILEAD OCTREOTIDE C UNK MIDAZOLAM C UNK FENTANYL C ZOSYN C UNK ACETAMINOPHEN C UNK PANTOPRAZOLE C UNK 10699214 FDA Received Date Case # Case Type Health Professional Outcomes Manufacturer Control # Age Sex Country 08-Jan-2015 10699214 EXPEDITED (15-DAY) US- GILEAD-2015-0130061 67 YR Female USA Preferred Term Product Role Route Dosage Text Duration Manufacturer Urine odour abnormal HARVONI S UNKNOWN UNK GILEAD Fatigue URSODIOL C 300 mg, BID Visual impairment PROMACTA C 50 mg, QD Dizziness NADOLOL C 20 mg, QD SPIRONOLACTONE C 100 mg, QD L-THYROXINE / 00068001/ C 50 µg, QD SUCRALFATE C 1 DF, QID MULTIVITAMIN / 07504101/ C 1 DF, QD HYDROXYZINE HYDROCHLORIDE C 25 mg, TID Page: 43 of

From: 10-OCT-2014 To: 15-MAR-2015 - 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 bereported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population. #hepatitis

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