Drug · FAERS side-effect profile with label screen
Etravirine side effects: what 4,420 FDA adverse event reports show
Drug class
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
4,420 reports · 88% serious · 474 with death outcome · 30% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Etravirine tablets in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older .
FDA label, Indications and Usage
What it is
Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Reporting / coding artifact 9Lab value / disease marker 3Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 169 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eyelid ptosis | 107 | 50.4 41.8–60.9ROR 51.6 · χ² 5,081 / p <1e-300 | 49.5 EB05 42.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 1% (drug 30%) · 93% clinician | no trial data cached |
| Drug resistance | 266 | 49.6 44.1–55.8ROR 52.7 · χ² 12,509 / p <1e-300 | 49.0 EB05 44.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 34.4 | no trial data cached |
| Anhedonia | 219 | 39.5 34.7–45.0ROR 41.5 · χ² 8,129 / p <1e-300 | 39.1 EB05 34.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 100% consumer | no trial data cached |
| Economic problem | 84 | 26.0 21.0–32.1ROR 26.5 · χ² 1,984 / p <1e-300 | 25.7 EB05 21.4 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 17.6 | no trial data cached |
| Osteopenia | 82 | 25.6 20.7–31.8ROR 26.1 · χ² 1,907 / p <1e-300 | 25.4 EB05 21.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Diplopia (double vision) | 101 | 18.5 15.3–22.5ROR 18.9 · χ² 1,651 / p <1e-300 | 18.4 EB05 15.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 0% (drug 30%) · 93% clinician | no trial data cached |
| Osteoporosis | 126 | 14.6 12.2–17.3ROR 15.0 · χ² 1,575 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Nephropathy | 28 | 14.2 9.8–20.5ROR 14.3 · χ² 329 / p 7e-74 | 13.8 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Premature baby | 87 | 13.7 11.1–16.9ROR 14.0 · χ² 1,010 / p 5e-222 | 13.6 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 54% (drug 30%) | no trial data cached |
| End stage renal disease | 52 | 13.4 10.2–17.6ROR 13.6 · χ² 584 / p 2e-129 | 13.2 EB05 10.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Bone density decreased | 85 | 12.8 10.3–15.8ROR 13.0 · χ² 908 / p 8e-200 | 12.6 EB05 10.5 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.6 | no trial data cached |
| Blood iron decreased | 31 | 12.5 8.8–17.8ROR 12.6 · χ² 316 / p 6e-71 | 12.0 EB05 8.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 10.8 · 94% clinician | no trial data cached |
| Chronic kidney disease | 192 | 11.9 10.4–13.7ROR 12.4 · χ² 1,910 / p <1e-300 | 11.8 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Drug level increased | 41 | 11.8 8.7–16.0ROR 11.9 · χ² 393 / p 1e-87 | 11.4 EB05 8.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 90% clinician | no trial data cached |
| Treatment failure | 203 | 11.8 10.3–13.5ROR 12.3 · χ² 1,990 / p <1e-300 | 11.7 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Hepatitis c | 29 | 11.3 7.8–16.2ROR 11.4 · χ² 261 / p 5e-59 | 10.7 EB05 7.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Multiple fractures | 37 | 10.6 7.7–14.6ROR 10.7 · χ² 312 / p 4e-70 | 10.1 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Decreased activity | 22 | 9.8 6.4–14.8ROR 9.8 · χ² 164 / p 8e-38 | 8.8 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Foetal exposure during pregnancy | 166 | 9.7 8.4–11.3ROR 10.0 · χ² 1,290 / p 7e-283 | 9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · ♀ 70% (drug 30%) | no trial data cached |
| Emotional distress | 243 | 9.5 8.4–10.7ROR 10.0 · χ² 1,847 / p <1e-300 | 9.4 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 100% consumer | no trial data cached |
| Hypercholesterolaemia | 19 | 9.4 6.0–14.8ROR 9.5 · χ² 135 / p 2e-31 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Drug level decreased | 20 | 9.3 6.0–14.4ROR 9.3 · χ² 140 / p 2e-32 | 8.2 EB05 5.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 95% clinician | no trial data cached |
| Nephropathy toxic | 21 | 9.0 5.8–13.7ROR 9.0 · χ² 140 / p 1e-32 | 8.0 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 90% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 35 | 8.7 6.3–12.1ROR 8.8 · χ² 231 / p 2e-52 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 52% (drug 30%) · 91% clinician | no trial data cached |
| Proteinuria | 34 | 8.6 6.1–12.0ROR 8.6 · χ² 220 / p 6e-50 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Treatment noncompliance | 97 | 8.5 7.0–10.3ROR 8.6 · χ² 633 / p 5e-140 | 8.2 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · ♀ 53% (drug 30%) | no trial data cached |
| Bone loss | 27 | 8.4 5.8–12.3ROR 8.5 · χ² 170 / p 4e-39 | 7.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Drug interaction | 281 | 8.4 7.5–9.4ROR 8.9 · χ² 1,839 / p <1e-300 | 8.3 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Hepatic cirrhosis | 33 | 8.4 6.0–11.8ROR 8.4 · χ² 207 / p 3e-47 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Exposure during pregnancy | 109 | 8.3 6.9–10.0ROR 8.5 · χ² 696 / p 1e-153 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 100% (drug 30%) | no trial data cached |
| Premature delivery | 28 | 8.3 5.7–12.0ROR 8.4 · χ² 173 / p 9e-40 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 100% (drug 30%) | no trial data cached |
| Glomerular filtration rate decreased | 21 | 8.2 5.4–12.6ROR 8.3 · χ² 126 / p 1e-29 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · ♀ 10% (drug 30%) | no trial data cached |
| Hepatic steatosis | 32 | 8.2 5.8–11.5ROR 8.2 · χ² 194 / p 2e-44 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · ♀ 0% (drug 30%) | no trial data cached |
| Dermatitis allergic | 21 | 8.0 5.2–12.3ROR 8.0 · χ² 122 / p 1e-28 | 7.1 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 76% (drug 30%) · 100% clinician | no trial data cached |
| Osteonecrosis (bone death) | 55 | 7.9 6.1–10.3ROR 8.0 · χ² 324 / p 1e-72 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Quality of life decreased | 22 | 7.8 5.1–11.8ROR 7.8 · χ² 123 / p 7e-29 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Hepatic encephalopathy | 15 | 7.6 4.6–12.6ROR 7.6 · χ² 80 / p 2e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Hyperlipidaemia | 19 | 7.5 4.8–11.8ROR 7.6 · χ² 101 / p 5e-24 | 6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Toxic skin eruption | 16 | 7.5 4.6–12.3ROR 7.5 · χ² 84 / p 3e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Hyperbilirubinaemia | 16 | 7.4 4.5–12.0ROR 7.4 · χ² 82 / p 7e-20 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pain | 286 | 2.2 2.0–2.5ROR 2.3 · χ² 193 / p 4e-44 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Drug interaction | 281 | 8.4 7.5–9.4ROR 8.9 · χ² 1,839 / p <1e-300 | 8.3 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Drug resistance | 266 | 49.6 44.1–55.8ROR 52.7 · χ² 12,509 / p <1e-300 | 49.0 EB05 44.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 34.4 | no trial data cached |
| Anxiety | 247 | 4.1 3.6–4.6ROR 4.3 · χ² 585 / p 1e-129 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Emotional distress | 243 | 9.5 8.4–10.7ROR 10.0 · χ² 1,847 / p <1e-300 | 9.4 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 100% consumer | no trial data cached |
| Anhedonia | 219 | 39.5 34.7–45.0ROR 41.5 · χ² 8,129 / p <1e-300 | 39.1 EB05 34.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 100% consumer | no trial data cached |
| Treatment failure | 203 | 11.8 10.3–13.5ROR 12.3 · χ² 1,990 / p <1e-300 | 11.7 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Chronic kidney disease | 192 | 11.9 10.4–13.7ROR 12.4 · χ² 1,910 / p <1e-300 | 11.8 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Foetal exposure during pregnancy | 166 | 9.7 8.4–11.3ROR 10.0 · χ² 1,290 / p 7e-283 | 9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · ♀ 70% (drug 30%) | no trial data cached |
| Renal failure (kidney failure) | 165 | 5.9 5.0–6.8ROR 6.0 · χ² 663 / p 2e-146 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Anaemia (low red blood cells) | 164 | 4.1 3.5–4.7ROR 4.2 · χ² 381 / p 4e-85 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Depression | 133 | 2.8 2.3–3.3ROR 2.8 · χ² 149 / p 1e-34 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 128 | 4.0 3.4–4.7ROR 4.1 · χ² 285 / p 2e-64 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Osteoporosis | 126 | 14.6 12.2–17.3ROR 15.0 · χ² 1,575 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Exposure during pregnancy | 109 | 8.3 6.9–10.0ROR 8.5 · χ² 696 / p 1e-153 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 100% (drug 30%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Eyelid ptosis — n=107, PRR 50.4
- Anhedonia — n=219, PRR 39.5
- Osteopenia — n=82, PRR 25.6
- Diplopia — n=101, PRR 18.5
- Osteoporosis — n=126, PRR 14.6
- Nephropathy — n=28, PRR 14.2
- Premature baby — n=87, PRR 13.7
- End stage renal disease — n=52, PRR 13.4
- Chronic kidney disease — n=192, PRR 11.9
- Multiple fractures — n=37, PRR 10.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Etravirine?
In FDA FAERS, the most frequently co-reported reaction terms for Etravirine are pain, anxiety, emotional distress, anhedonia, chronic kidney disease, renal failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Etravirine have an FDA boxed warning?
No. The FDA label retrieved for Etravirine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Etravirine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 458bb39e-2e87-b4b4-e063-6394a90ae867, effective 20251218; matched on
openfda.generic_name.exact:"ETRAVIRINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 209 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.