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Viread Adverse Events Reported to the FDA Over Time

How are Viread adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Viread, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Viread is flagged as the suspect drug causing the adverse event.

Most Common Viread Adverse Events Reported to the FDA

What are the most common Viread adverse events reported to the FDA?

Drug Exposure During Pregnancy
643 (2.89%)
Abortion Spontaneous
423 (1.9%)
Renal Failure Acute
412 (1.85%)
Renal Failure
271 (1.22%)
Pyrexia
232 (1.04%)
Vomiting
220 (.99%)
Pregnancy
211 (.95%)
Blood Creatinine Increased
193 (.87%)
Anaemia
192 (.86%)
Immune Reconstitution Syndrome
190 (.85%)
Alanine Aminotransferase Increased
179 (.81%)
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Lactic Acidosis
178 (.8%)
Fanconi Syndrome Acquired
166 (.75%)
Aspartate Aminotransferase Increase...
163 (.73%)
Diarrhoea
152 (.68%)
Nausea
151 (.68%)
Weight Decreased
151 (.68%)
Premature Baby
138 (.62%)
Asthenia
136 (.61%)
Blood Alkaline Phosphatase Increase...
134 (.6%)
Renal Tubular Disorder
133 (.6%)
Dehydration
131 (.59%)
Proteinuria
115 (.52%)
Stillbirth
115 (.52%)
Abdominal Pain
112 (.5%)
Cardiac Murmur
112 (.5%)
Abdominal Distension
110 (.49%)
Congenital Anomaly
108 (.49%)
Haemoglobin Decreased
105 (.47%)
Osteoporosis
105 (.47%)
Renal Impairment
105 (.47%)
Hypophosphataemia
104 (.47%)
Metabolic Acidosis
99 (.45%)
Maternal Drugs Affecting Foetus
98 (.44%)
Thrombocytopenia
98 (.44%)
Death
96 (.43%)
Blood Creatine Phosphokinase Increa...
92 (.41%)
Drug Interaction
92 (.41%)
Blood Bilirubin Increased
87 (.39%)
Hepatitis
87 (.39%)
Lipodystrophy Acquired
87 (.39%)
Osteonecrosis
87 (.39%)
Cryptorchism
86 (.39%)
Dyspnoea
86 (.39%)
Sepsis
84 (.38%)
Fatigue
80 (.36%)
General Physical Health Deteriorati...
80 (.36%)
Drug Ineffective
77 (.35%)
Headache
77 (.35%)
Rhabdomyolysis
77 (.35%)
Abortion Induced
76 (.34%)
Hepatic Cirrhosis
74 (.33%)
Nephrolithiasis
73 (.33%)
Abdominal Hernia
72 (.32%)
Fanconi Syndrome
72 (.32%)
Myalgia
72 (.32%)
Neutropenia
71 (.32%)
Pneumonia
70 (.31%)
Caesarean Section
69 (.31%)
Gamma-glutamyltransferase Increased
68 (.31%)
Jaundice
68 (.31%)
Ultrasound Antenatal Screen Abnorma...
68 (.31%)
Confusional State
66 (.3%)
Rash
66 (.3%)
Renal Tubular Necrosis
66 (.3%)
Blood Phosphorus Decreased
62 (.28%)
Hepatic Failure
62 (.28%)
Pain In Extremity
62 (.28%)
Oedema Peripheral
61 (.27%)
Mitochondrial Toxicity
60 (.27%)
Hepatic Steatosis
59 (.27%)
Pancreatitis
59 (.27%)
Viral Load Increased
59 (.27%)
Anorexia
57 (.26%)
Hypokalaemia
57 (.26%)
Depressed Level Of Consciousness
56 (.25%)
Leukopenia
56 (.25%)
Pancytopenia
56 (.25%)
Depression
55 (.25%)
Fall
55 (.25%)
Myocardial Infarction
55 (.25%)
Pruritus
55 (.25%)
Arthralgia
53 (.24%)
Chest Pain
53 (.24%)
Back Pain
52 (.23%)
Lymphadenopathy
52 (.23%)
Osteomalacia
52 (.23%)
Cough
51 (.23%)
Liver Disorder
51 (.23%)
Malaise
51 (.23%)
Diabetes Mellitus
50 (.22%)
Gastroenteritis
50 (.22%)
Dialysis
49 (.22%)
Glycosuria
49 (.22%)
Polydactyly
49 (.22%)
Blood Lactic Acid Increased
48 (.22%)
Bone Pain
48 (.22%)
Ascites
46 (.21%)
Diplopia
46 (.21%)
Nephropathy Toxic
46 (.21%)
Overdose
46 (.21%)

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This graph shows the top adverse events submitted to the FDA for Viread, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Viread is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Viread

What are the most common Viread adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Viread, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Viread is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Viread According to Those Reporting Adverse Events

Why are people taking Viread, according to those reporting adverse events to the FDA?

Hiv Infection
5641
Hepatitis B
458
Drug Exposure During Pregnancy
274
Drug Use For Unknown Indication
213
Prophylaxis Against Hiv Infection
171
Antiretroviral Therapy
165
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Acquired Immunodeficiency Syndrome
151
Product Used For Unknown Indication
136
Antiviral Treatment
62
Hiv Test Positive
56
Maternal Exposure During Pregnancy
27
Antiviral Prophylaxis
22
Retroviral Infection
22
Systemic Antiviral Treatment
19
Human Immunodeficiency Virus Transm...
18
Maternal Exposure Timing Unspecifie...
15
Hepatitis B Virus
14
Prophylaxis
14
Hepatitis B Virus Test
13
Viral Infection
11
Infection
10
Acute Hiv Infection
10
Hepatic Cirrhosis
7
Hepatitis
7
Ill-defined Disorder
7
Lipodystrophy Acquired
6
Asymptomatic Hiv Infection
6
Hepatitis C
6
Pathogen Resistance
5
Hiv Infection Cdc Category B3
4
Blood Creatinine Increased
4
Hiv Test
4
Hepatitis B Surface Antigen
3
Chronic Hepatitis
3
Hepatitis B Virus Test Positive
2
Haematuria
2
Anti-infective Therapy
2
Hepatitis B E Antigen Negative
2
Immunodeficiency
2
Infection Prophylaxis
2
Proteinuria
2
Cd4 Lymphocytes Decreased
2
Antiviral Drug Level
2
Hepatitis Chronic Persistent
2
Intentional Overdose
2
Hepatitis Viral
2
Kaposis Sarcoma
2
Pneumocystis Jiroveci Infection
2
Hypophosphataemia
2
Hepatitis D
2
Foetal Exposure During Pregnancy
1

Drug Labels

LabelLabelerEffective
VireadState of Florida DOH Central Pharmacy13-APR-10
VireadCardinal Health13-OCT-11
VireadGilead Sciences, Inc.15-JAN-13
VireadREMEDYREPACK INC. 28-MAR-13
VireadCardinal Health17-APR-13

Viread Case Reports

What Viread safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Viread. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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