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ETRAVIRINE

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Etravirine Adverse Events Reported to the FDA Over Time

How are Etravirine adverse event reports trending over time?

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

Most Common Etravirine Adverse Events Reported to the FDA

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

Lipodystrophy Acquired
88 (2.57%)
Drug Exposure During Pregnancy
69 (2.01%)
Exomphalos
63 (1.84%)
Bladder Agenesis
61 (1.78%)
Eyelid Ptosis
51 (1.49%)
Immune Reconstitution Syndrome
51 (1.49%)
Mitochondrial Toxicity
51 (1.49%)
Diplopia
50 (1.46%)
Progressive External Ophthalmoplegi...
50 (1.46%)
Anal Atresia
48 (1.4%)
Congenital Genital Malformation
48 (1.4%)
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Renal Failure Acute
45 (1.31%)
Pyrexia
42 (1.23%)
Cloacal Exstrophy
40 (1.17%)
Caudal Regression Syndrome
39 (1.14%)
Meningomyelocele
39 (1.14%)
Alanine Aminotransferase Increased
36 (1.05%)
Anaemia
36 (1.05%)
Umbilical Cord Abnormality
36 (1.05%)
Rash
35 (1.02%)
Blood Iron Decreased
34 (.99%)
Diarrhoea
34 (.99%)
Gastrointestinal Malformation
33 (.96%)
Genitalia External Ambiguous
32 (.93%)
Meconium Stain
32 (.93%)
Aspartate Aminotransferase Increase...
30 (.88%)
Pancreatitis
30 (.88%)
Premature Baby
30 (.88%)
Sepsis
29 (.85%)
Gastrointestinal Disorder Congenita...
27 (.79%)
Pneumonia
26 (.76%)
Pain In Extremity
24 (.7%)
Hepatotoxicity
23 (.67%)
Tethered Cord Syndrome
23 (.67%)
Thrombocytopenia
22 (.64%)
Erythema
21 (.61%)
Hypersensitivity
21 (.61%)
Toxic Epidermal Necrolysis
21 (.61%)
Abortion Spontaneous
20 (.58%)
Blood Creatine Phosphokinase Increa...
20 (.58%)
Hyperlipidaemia
19 (.55%)
Neuropathy Peripheral
19 (.55%)
Pancytopenia
19 (.55%)
Premature Labour
19 (.55%)
Drug Interaction
17 (.5%)
Hepatitis
17 (.5%)
Tubulointerstitial Nephritis
17 (.5%)
Asthenia
16 (.47%)
Headache
16 (.47%)
Rhabdomyolysis
16 (.47%)
Vomiting
16 (.47%)
Arthralgia
15 (.44%)
Congenital Musculoskeletal Anomaly
15 (.44%)
Musculoskeletal Deformity
15 (.44%)
Spine Malformation
15 (.44%)
Visual Impairment
15 (.44%)
Weight Decreased
15 (.44%)
Acute Haemorrhagic Conjunctivitis
14 (.41%)
Hepatic Failure
14 (.41%)
Hyperglycaemia
14 (.41%)
Liver Function Test Abnormal
14 (.41%)
Nausea
14 (.41%)
Oesophageal Candidiasis
14 (.41%)
Proteinuria
14 (.41%)
Abdominal Distension
13 (.38%)
Anorexia
13 (.38%)
Dehydration
13 (.38%)
Gastrointestinal Disorder
13 (.38%)
Tachycardia
13 (.38%)
Decreased Appetite
12 (.35%)
Encephalopathy
12 (.35%)
Fatigue
12 (.35%)
Hepatitis B
12 (.35%)
Rash Maculo-papular
12 (.35%)
Renal Failure
12 (.35%)
Septic Shock
12 (.35%)
Blood Bilirubin Increased
11 (.32%)
Cd4 Lymphocytes Decreased
11 (.32%)
Gastric Ulcer
11 (.32%)
Paraesthesia
11 (.32%)
Stevens-johnson Syndrome
11 (.32%)
Tearfulness
11 (.32%)
Urosepsis
11 (.32%)
Abdominal Pain
10 (.29%)
Congenital Anomaly
10 (.29%)
Depression
10 (.29%)
Epistaxis
10 (.29%)
Maternal Drugs Affecting Foetus
10 (.29%)
Odynophagia
10 (.29%)
Polyarthritis
10 (.29%)
Blood Alkaline Phosphatase Increase...
9 (.26%)
Blood Creatinine Increased
9 (.26%)
Chest Pain
9 (.26%)
Death
9 (.26%)
Drug Hypersensitivity
9 (.26%)
Dyspnoea Exertional
9 (.26%)
Gastrooesophageal Reflux Disease
9 (.26%)
Haemoglobin Decreased
9 (.26%)
Hypertension
9 (.26%)
Myocardial Infarction
9 (.26%)
Oral Disorder
9 (.26%)

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

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

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

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

Hiv Infection
668
Drug Exposure During Pregnancy
60
Drug Use For Unknown Indication
18
Antiretroviral Therapy
12
Product Used For Unknown Indication
10
Antiviral Treatment
6
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Hiv Test Positive
3
Hepatitis B
2
Acquired Immunodeficiency Syndrome
2
Foetal Exposure During Pregnancy
1
Asymptomatic Hiv Infection
1
End Stage Aids
1
Urticaria
1
Pathogen Resistance
1

Drug Labels

LabelLabelerEffective
IntelenceState of Florida DOH Central Pharmacy06-AUG-10
IntelencePhysicians Total Care, Inc.02-JAN-13
IntelenceJanssen Products LP01-FEB-13
IntelenceREMEDYREPACK INC. 18-MAR-13

Etravirine Case Reports

What Etravirine 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 Etravirine. 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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