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
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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
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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