Nevirapine side effects: what 8,970 FDA adverse event reports show
Drug class
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Who reports
8,970 reports · 97% serious · 1,523 with death outcome · 47% female
Used for
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m 2 or greater .
What it is
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.
Boxed warning
LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure.
Causality screen of the 40 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 966 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Trisomy 17 | 10 | 7,687.1 2,115.9–27,927.4ROR 7,695.7 · χ² 16,005 / p <1e-300 | 402.9 EB05 233.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Progressive external ophthalmoplegia | 81 | 3,891.6 2,724.8–5,558.0ROR 3,927.1 · χ² 115,788 / p <1e-300 | 1,076.8 EB05 893.9 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=81 · ♀ 0% (drug 47%) · 94% clinician | no trial data cached |
| Conjunctivalisation | 16 | 3,074.8 1,455.1–6,497.7ROR 3,080.3 · χ² 19,774 / p <1e-300 | 510.1 EB05 332.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Ultrasound antenatal screen | 48 | 2,406.4 1,606.8–3,603.9ROR 2,419.3 · χ² 55,307 / p <1e-300 | 799.6 EB05 627.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=48 · 100% clinician | no trial data cached |
| Human immunodeficiency virus transmission | 124 | 2,150.1 1,684.9–2,743.7ROR 2,180.2 · χ² 136,736 / p <1e-300 | 948.8 EB05 816.7 · IC025 +7.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=124 · 100% clinician | no trial data cached |
| Retroperitoneal disorder | 10 | 2,096.5 890.6–4,935.2ROR 2,098.8 · χ² 9,900 / p <1e-300 | 353.8 EB05 205.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Spinocerebellar disorder | 18 | 1,431.4 795.2–2,576.4ROR 1,434.3 · χ² 15,005 / p <1e-300 | 454.7 EB05 304.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Peritoneal thickening | 10 | 1,281.2 591.6–2,774.7ROR 1,282.6 · χ² 7,421 / p <1e-300 | 319.8 EB05 185.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pinealoblastoma | 33 | 1,268.4 829.8–1,938.7ROR 1,273.1 · χ² 26,150 / p <1e-300 | 554.1 EB05 412.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 0% (drug 47%) | no trial data cached |
| Postpartum sepsis | 13 | 681.4 367.1–1,264.5ROR 682.3 · χ² 6,302 / p <1e-300 | 296.6 EB05 184.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Dandy-walker syndrome | 56 | 642.5 478.2–863.3ROR 646.5 · χ² 27,553 / p <1e-300 | 428.8 EB05 342.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 0% (drug 47%) · 96% clinician | no trial data cached |
| Genetic polymorphism | 12 | 615.0 325.4–1,162.1ROR 615.8 · χ² 5,332 / p <1e-300 | 273.9 EB05 167.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Supernumerary nipple | 16 | 585.7 338.5–1,013.4ROR 586.7 · χ² 6,988 / p <1e-300 | 299.8 EB05 195.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Astrocytoma malignant | 19 | 576.5 348.9–952.7ROR 577.8 · χ² 8,278 / p <1e-300 | 315.0 EB05 213.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Mitochondrial toxicity | 159 | 561.5 472.7–667.0ROR 571.6 · χ² 71,097 / p <1e-300 | 428.4 EB05 375.3 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=159 · ♀ 13% (drug 47%) · 92% clinician | no trial data cached |
| Viral mutation identified | 696 | 540.8 499.3–585.8ROR 586.2 · χ² 303,383 / p <1e-300 | 433.0 EB05 406.7 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=689 · 97% clinician | no trial data cached |
| Aids related complication | 11 | 469.8 245.7–898.1ROR 470.3 · χ² 3,894 / p <1e-300 | 232.9 EB05 138.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Foetal exposure during delivery | 112 | 458.0 374.3–560.3ROR 463.7 · χ² 42,227 / p <1e-300 | 358.8 EB05 306.4 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=112 · 100% clinician | no trial data cached |
| Virologic failure | 800 | 407.6 379.2–438.2ROR 447.4 · χ² 275,485 / p <1e-300 | 343.7 EB05 324.2 · IC025 +8.0 3/3 methods agree | Labeled (related wording) related wording | serious n=799 · 98% clinician | no trial data cached |
| Lipodystrophy acquired | 314 | 404.1 359.1–454.7ROR 418.7 · χ² 107,100 / p <1e-300 | 336.9 EB05 306.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=313 · ♀ 17% (drug 47%) · 93% clinician | no trial data cached |
| Hiv infection | 432 | 390.7 353.6–431.7ROR 410.4 · χ² 143,276 / p <1e-300 | 329.4 EB05 304.1 · IC025 +7.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=431 · 98% clinician | no trial data cached |
| Congenital naevus | 19 | 377.7 232.6–613.3ROR 378.5 · χ² 5,815 / p <1e-300 | 244.9 EB05 165.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Immune reconstitution syndrome | 175 | 361.6 308.8–423.5ROR 368.8 · χ² 54,096 / p <1e-300 | 302.4 EB05 266.6 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=174 | no trial data cached |
| Vertical infection transmission | 14 | 329.4 188.3–576.5ROR 330.0 · χ² 3,729 / p <1e-300 | 207.2 EB05 131.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Acoustic stimulation tests abnormal | 19 | 324.6 200.9–524.4ROR 325.3 · χ² 5,093 / p <1e-300 | 221.5 EB05 149.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Brachydactyly | 22 | 295.0 189.3–459.5ROR 295.7 · χ² 5,457 / p <1e-300 | 213.4 EB05 148.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Retinoblastoma | 10 | 235.3 122.8–450.9ROR 235.6 · χ² 1,910 / p <1e-300 | 152.2 EB05 88.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mitochondrial myopathy | 20 | 235.3 148.6–372.6ROR 235.8 · χ² 4,024 / p <1e-300 | 177.7 EB05 121.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Trisomy 18 | 35 | 234.6 165.8–332.0ROR 235.6 · χ² 7,180 / p <1e-300 | 191.0 EB05 143.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 19% (drug 47%) · 100% clinician | no trial data cached |
| Macrocephaly | 32 | 213.9 149.0–307.1ROR 214.7 · χ² 6,012 / p <1e-300 | 175.5 EB05 130.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 47%) · 94% clinician | no trial data cached |
| Hiv test positive | 51 | 193.4 145.5–257.2ROR 194.5 · χ² 8,832 / p <1e-300 | 167.4 EB05 132.3 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=50 | no trial data cached |
| Low set ears | 30 | 181.6 125.3–263.2ROR 182.2 · χ² 4,828 / p <1e-300 | 152.3 EB05 111.8 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=30 | no trial data cached |
| Hydrops foetalis | 43 | 176.8 129.7–240.9ROR 177.6 · χ² 6,818 / p <1e-300 | 153.2 EB05 118.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=43 · 100% clinician | no trial data cached |
| Laryngomalacia | 22 | 162.6 105.6–250.4ROR 163.0 · χ² 3,152 / p <1e-300 | 134.5 EB05 93.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Maternal condition affecting foetus | 14 | 156.7 91.2–269.2ROR 157.0 · χ² 1,885 / p <1e-300 | 122.7 EB05 77.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cerebellar hypoplasia | 10 | 146.0 77.1–276.5ROR 146.1 · χ² 1,221 / p 8e-268 | 109.3 EB05 63.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nodular regenerative hyperplasia | 41 | 143.0 104.4–196.0ROR 143.7 · χ² 5,312 / p <1e-300 | 126.9 EB05 97.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 26% (drug 47%) · 93% clinician | no trial data cached |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 19 | 141.3 89.0–224.5ROR 141.6 · χ² 2,364 / p <1e-300 | 117.8 EB05 79.7 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Encephalocele | 14 | 137.4 80.2–235.5ROR 137.6 · χ² 1,663 / p <1e-300 | 110.6 EB05 70.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Congenital central nervous system anomaly | 57 | 130.5 100.0–170.3ROR 131.4 · χ² 6,813 / p <1e-300 | 118.8 EB05 95.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 0% (drug 47%) · 91% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 1,116 | 32.6 30.8–34.4ROR 37.0 · χ² 33,756 / p <1e-300 | 32.1 EB05 30.5 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.4 | no trial data cached |
| Drug resistance | 1,033 | 98.0 92.4–103.9ROR 110.6 · χ² 95,134 / p <1e-300 | 93.9 EB05 89.2 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 62.4 · 96% clinician | no trial data cached |
| Virologic failure | 800 | 407.6 379.2–438.2ROR 447.4 · χ² 275,485 / p <1e-300 | 343.7 EB05 324.2 · IC025 +8.0 3/3 methods agree | Labeled (related wording) related wording | serious n=799 · 98% clinician | no trial data cached |
| Viral mutation identified | 696 | 540.8 499.3–585.8ROR 586.2 · χ² 303,383 / p <1e-300 | 433.0 EB05 406.7 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=689 · 97% clinician | no trial data cached |
| Death | 501 | 1.4 1.2–1.5ROR 1.4 · χ² 49 / p 1e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.8 · 92% clinician | no trial data cached |
| Exposure during pregnancy | 463 | 17.5 16.0–19.2ROR 18.4 · χ² 7,168 / p <1e-300 | 17.4 EB05 16.1 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.5 · ♀ 93% (drug 47%) · 94% clinician | no trial data cached |
| Hiv infection | 432 | 390.7 353.6–431.7ROR 410.4 · χ² 143,276 / p <1e-300 | 329.4 EB05 304.1 · IC025 +7.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=431 · 98% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 406 | 0.7 0.7–0.8ROR 0.7 · χ² 47 / p 5e-12 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 · 93% clinician | no trial data cached |
| Pathogen resistance | 386 | 103.5 93.7–114.4ROR 108.2 · χ² 37,433 / p <1e-300 | 98.7 EB05 90.7 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 62.3 · 99% clinician | no trial data cached |
| Treatment failure | 335 | 9.6 8.6–10.6ROR 9.9 · χ² 2,564 / p <1e-300 | 9.5 EB05 8.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 100% clinician | no trial data cached |
| Anaemia (low red blood cells) | 333 | 4.1 3.7–4.5ROR 4.2 · χ² 778 / p 1e-171 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Pyrexia (fever) | 330 | 2.2 2.0–2.5ROR 2.3 · χ² 226 / p 2e-51 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Drug exposure during pregnancy | 315 | 21.5 19.3–24.0ROR 22.3 · χ² 6,101 / p <1e-300 | 21.3 EB05 19.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.6 · ♀ 78% (drug 47%) | no trial data cached |
| Lipodystrophy acquired | 314 | 404.1 359.1–454.7ROR 418.7 · χ² 107,100 / p <1e-300 | 336.9 EB05 306.8 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=313 · ♀ 17% (drug 47%) · 93% clinician | no trial data cached |
| Maternal exposure during pregnancy | 253 | 6.7 6.0–7.6ROR 6.9 · χ² 1,228 / p 2e-269 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · ♀ 96% (drug 47%) | 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.
- Progressive external ophthalmoplegia — n=81, PRR 3,891.6
- Ultrasound antenatal screen — n=48, PRR 2,406.4
- Pinealoblastoma — n=33, PRR 1,268.4
- Dandy-walker syndrome — n=56, PRR 642.5
- Mitochondrial toxicity — n=159, PRR 561.5
- Viral mutation identified — n=696, PRR 540.8
- Lipodystrophy acquired — n=314, PRR 404.1
- Brachydactyly — n=22, PRR 295.0
- Mitochondrial myopathy — n=20, PRR 235.3
- Trisomy 18 — n=35, PRR 234.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Nevirapine ↔ Hepatotoxicity.
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 Nevirapine?
In FDA FAERS, the most frequently co-reported reaction terms for Nevirapine are virologic failure, viral mutation identified, hiv infection, anaemia, pyrexia, lipodystrophy acquired. 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 Nevirapine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure.
Do FAERS signals prove that Nevirapine 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 2620b114-f53f-44f1-8708-697e86343090, effective 20240814; matched on
openfda.generic_name.exact:"NEVIRAPINE") - 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, 1,006 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.