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Sustiva Adverse Events Reported to the FDA Over Time

How are Sustiva adverse event reports trending over time?

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

Most Common Sustiva Adverse Events Reported to the FDA

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

Pregnancy
162 (2.43%)
Pyrexia
137 (2.06%)
Drug Exposure During Pregnancy
126 (1.89%)
Rash
81 (1.22%)
Abortion Induced
70 (1.05%)
Immune Reconstitution Syndrome
66 (.99%)
Thrombocytopenia
60 (.9%)
Abortion Spontaneous
59 (.89%)
Nervous System Disorder
55 (.83%)
Diarrhoea
51 (.77%)
Insomnia
47 (.71%)
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Lymphadenopathy
47 (.71%)
Renal Failure Acute
45 (.68%)
Abnormal Dreams
44 (.66%)
Dyspnoea
44 (.66%)
Hepatitis
44 (.66%)
Vomiting
44 (.66%)
Confusional State
42 (.63%)
Dizziness
42 (.63%)
Liver Function Test Abnormal
42 (.63%)
Myocardial Infarction
42 (.63%)
Headache
41 (.62%)
Anaemia
38 (.57%)
Asthenia
38 (.57%)
Depression
38 (.57%)
Hypertension
38 (.57%)
Lactic Acidosis
38 (.57%)
Nausea
36 (.54%)
Premature Baby
36 (.54%)
Weight Decreased
35 (.53%)
Jaundice
33 (.5%)
Nightmare
33 (.5%)
Cholestasis
32 (.48%)
Drug Interaction
32 (.48%)
General Physical Health Deteriorati...
32 (.48%)
Haemolytic Anaemia
32 (.48%)
Renal Impairment
32 (.48%)
Thrombotic Thrombocytopenic Purpura
31 (.47%)
Neutropenia
30 (.45%)
Drug Screen False Positive
29 (.44%)
Drug Screen Positive
29 (.44%)
Hepatic Encephalopathy
28 (.42%)
Death
27 (.41%)
Exomphalos
27 (.41%)
Renal Failure
27 (.41%)
Aspartate Aminotransferase Increase...
26 (.39%)
Caesarean Section
26 (.39%)
Lipodystrophy Acquired
26 (.39%)
Liver Disorder
26 (.39%)
Malaise
25 (.38%)
Alanine Aminotransferase Increased
24 (.36%)
Cardiac Malposition
24 (.36%)
Diaphragmatic Aplasia
24 (.36%)
Drug Ineffective
24 (.36%)
Microcephaly
24 (.36%)
Blood Alkaline Phosphatase Increase...
23 (.35%)
Congenital Anomaly
23 (.35%)
Hyperlipidaemia
23 (.35%)
Proteinuria
23 (.35%)
Pruritus
23 (.35%)
Abdominal Pain
22 (.33%)
Gamma-glutamyltransferase Increased
22 (.33%)
Delirium
21 (.32%)
Drug Resistance
21 (.32%)
Hallucination
21 (.32%)
Hepatic Displacement
21 (.32%)
Hyperbilirubinaemia
21 (.32%)
Ocular Icterus
21 (.32%)
Tachycardia
21 (.32%)
Deformity Thorax
20 (.3%)
Fatigue
20 (.3%)
Hepatomegaly
20 (.3%)
Hypersensitivity
20 (.3%)
Stillbirth
20 (.3%)
Blood Creatinine Increased
19 (.29%)
Cytolytic Hepatitis
19 (.29%)
Drug Level Increased
19 (.29%)
Drug Toxicity
19 (.29%)
Liver Transplant
19 (.29%)
Medication Error
19 (.29%)
Respiratory Distress
19 (.29%)
Shock
19 (.29%)
Tachypnoea
19 (.29%)
Acute Hepatic Failure
18 (.27%)
Atrial Septal Defect
18 (.27%)
Disease Recurrence
18 (.27%)
Hepatic Enzyme Increased
18 (.27%)
Hepatitis Fulminant
18 (.27%)
Pancreatitis
18 (.27%)
Urine Colour Abnormal
18 (.27%)
Arthralgia
17 (.26%)
Convulsion
17 (.26%)
Drug Hypersensitivity
17 (.26%)
Foetal Disorder
17 (.26%)
Hepatic Cirrhosis
17 (.26%)
Hepatic Necrosis
17 (.26%)
Hiv Infection
17 (.26%)
Myopathy
17 (.26%)
Osteonecrosis
17 (.26%)
Transaminases Increased
17 (.26%)
Cardiac Arrest
16 (.24%)

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

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

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

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

Hiv Infection
1640
Drug Use For Unknown Indication
67
Antiretroviral Therapy
61
Hiv Test Positive
42
Drug Exposure During Pregnancy
41
Acquired Immunodeficiency Syndrome
36
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Antiviral Treatment
26
Product Used For Unknown Indication
18
Adverse Event
8
Prophylaxis Against Hiv Infection
6
Antiviral Prophylaxis
5
Ill-defined Disorder
3
Pathogen Resistance
2
Systemic Antiviral Treatment
2
Maternal Exposure Timing Unspecifie...
2
Hiv Test
2
Metabolic Disorder
2
Acute Hiv Infection
1
Unevaluable Event
1
Epilepsy
1
Viral Infection
1
Aids Related Complication
1
Immunodeficiency
1
Retroviral Infection
1

Drug Labels

LabelLabelerEffective
SustivaBristol-Myers Squibb Pharma Company01-JAN-13
SustivaPhysicians Total Care, Inc.02-JAN-13

Sustiva Case Reports

What Sustiva 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 Sustiva. 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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