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Atripla Adverse Events Reported to the FDA Over Time

How are Atripla adverse event reports trending over time?

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

Most Common Atripla Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
301 (2.63%)
Abortion Spontaneous
291 (2.54%)
Renal Failure Acute
166 (1.45%)
Anaemia
141 (1.23%)
Pyrexia
108 (.94%)
Vomiting
106 (.93%)
Immune Reconstitution Syndrome
101 (.88%)
Pregnancy
95 (.83%)
Diarrhoea
94 (.82%)
Renal Failure
94 (.82%)
Premature Baby
92 (.8%)
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Nausea
91 (.79%)
Alanine Aminotransferase Increased
81 (.71%)
Haemoglobin Decreased
80 (.7%)
Viral Load Increased
72 (.63%)
Maternal Drugs Affecting Foetus
71 (.62%)
Aspartate Aminotransferase Increase...
68 (.59%)
Dyspnoea
68 (.59%)
Death
67 (.59%)
Lactic Acidosis
67 (.59%)
Neutropenia
67 (.59%)
Asthenia
65 (.57%)
Sepsis
65 (.57%)
Stillbirth
64 (.56%)
Depression
58 (.51%)
Pneumonia
58 (.51%)
Blood Alkaline Phosphatase Increase...
55 (.48%)
Congenital Anomaly
54 (.47%)
Lipodystrophy Acquired
53 (.46%)
Thrombocytopenia
53 (.46%)
Caesarean Section
52 (.45%)
Confusional State
52 (.45%)
Cough
50 (.44%)
Dehydration
50 (.44%)
Ultrasound Antenatal Screen Abnorma...
49 (.43%)
Abdominal Pain
47 (.41%)
Headache
47 (.41%)
Hepatitis
45 (.39%)
Renal Impairment
44 (.38%)
Rhabdomyolysis
44 (.38%)
Weight Decreased
44 (.38%)
Drug Ineffective
42 (.37%)
Rash
42 (.37%)
Cardiac Murmur
41 (.36%)
Metabolic Acidosis
41 (.36%)
Blood Creatinine Increased
40 (.35%)
Gastroenteritis
40 (.35%)
Dizziness
39 (.34%)
Abortion Induced
38 (.33%)
Congenital Teratoma
38 (.33%)
Drug Interaction
38 (.33%)
Osteonecrosis
38 (.33%)
Chest Pain
37 (.32%)
Fatigue
37 (.32%)
Leukopenia
37 (.32%)
Nephrolithiasis
37 (.32%)
Blood Bilirubin Increased
36 (.31%)
Convulsion
36 (.31%)
Drug Resistance
36 (.31%)
Mitochondrial Toxicity
36 (.31%)
Pancytopenia
36 (.31%)
Renal Tubular Disorder
36 (.31%)
Abdominal Distension
35 (.31%)
Blood Creatine Phosphokinase Increa...
35 (.31%)
Cryptorchism
35 (.31%)
Renal Tubular Necrosis
35 (.31%)
Liver Function Test Abnormal
34 (.3%)
Malaise
34 (.3%)
Osteoporosis
33 (.29%)
Diplopia
32 (.28%)
Respiratory Distress
32 (.28%)
Eyelid Ptosis
31 (.27%)
Hepatic Failure
31 (.27%)
Liver Disorder
31 (.27%)
Oedema Peripheral
31 (.27%)
Decreased Appetite
30 (.26%)
Hypotension
29 (.25%)
Myalgia
29 (.25%)
Portal Hypertension
29 (.25%)
Malaria
28 (.24%)
Overdose
28 (.24%)
Pruritus
28 (.24%)
Trisomy 21
28 (.24%)
Lethargy
27 (.24%)
Progressive External Ophthalmoplegi...
27 (.24%)
Cytolytic Hepatitis
26 (.23%)
Drug Eruption
26 (.23%)
Vanishing Bile Duct Syndrome
26 (.23%)
Completed Suicide
25 (.22%)
Fall
25 (.22%)
Insomnia
25 (.22%)
Myocardial Infarction
25 (.22%)
Pain In Extremity
25 (.22%)
Suicidal Ideation
25 (.22%)
Ventricular Septal Defect
25 (.22%)
Abnormal Dreams
24 (.21%)
Gamma-glutamyltransferase Increased
24 (.21%)
Hepatic Enzyme Increased
24 (.21%)
Histiocytosis Haematophagic
24 (.21%)
Pulmonary Tuberculosis
24 (.21%)
Aplasia Pure Red Cell
23 (.2%)

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This graph shows the top adverse events submitted to the FDA for Atripla, 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 Atripla 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 Atripla

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

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This graph shows the top categories of adverse events submitted to the FDA for Atripla, 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 Atripla 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 Atripla According to Those Reporting Adverse Events

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

Hiv Infection
3152
Drug Exposure During Pregnancy
224
Prophylaxis Against Hiv Infection
156
Antiretroviral Therapy
111
Drug Use For Unknown Indication
94
Product Used For Unknown Indication
91
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Hepatitis B
74
Hiv Test Positive
54
Acquired Immunodeficiency Syndrome
42
Antiviral Treatment
23
Maternal Exposure Timing Unspecifie...
20
Maternal Exposure During Pregnancy
20
Human Immunodeficiency Virus Transm...
17
Systemic Antiviral Treatment
17
Antiviral Prophylaxis
10
Prophylaxis
8
Pathogen Resistance
7
Retroviral Infection
7
Viral Infection
6
Infection
4
Intentional Drug Misuse
3
Acute Hiv Infection
3
Immunodeficiency
3
Lipodystrophy Acquired
3
Hepatitis B Virus Test
2
Urticaria
2
Hiv Infection Cdc Group Iv Subgroup...
2
Hiv Infection Cdc Category A2
2
Infection Prophylaxis
2
Pneumocystis Jiroveci Infection
2
Hepatitis C
2
Foetal Exposure During Pregnancy
1
Autoimmune Disorder
1
Hiv Infection Cdc Group Iv Subgroup...
1
Kaposis Sarcoma
1
Hiv Infection Cdc Group Iv Subgroup...
1
Anti-infective Therapy
1
Antifungal Prophylaxis
1
Diffuse Large B-cell Lymphoma
1
Ill-defined Disorder
1
Hepatitis Viral
1
Splenectomy
1
Hiv Wasting Syndrome
1
Anosmia
1
Liver Disorder
1
Immune System Disorder
1
Hiv Antibody
1
Asymptomatic Hiv Infection
1
Acidosis
1

Drug Labels

LabelLabelerEffective
AtriplaState of Florida DOH Central Pharmacy12-MAR-10
AtriplaLake Erie Medical DBA Quality Care Products LLC13-NOV-12
AtriplaBristol Myers Squibb & Gilead Sciences, LLC16-JAN-13
AtriplaREMEDYREPACK INC. 29-MAR-13
AtriplaBristol Myers Squibb & Gilead Sciences, LLC23-APR-13
AtriplaPhysicians Total Care, Inc.03-MAY-13

Atripla Case Reports

What Atripla 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 Atripla. 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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