Drug · FAERS side-effect profile with label screen
Terbinafine Hydrochloride side effects: what 8,829 FDA adverse event reports show
Drug class
Not stated in label
Who reports
8,829 reports · 77% serious · 532 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.
FDA label, Indications and Usage
What it is
Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride.
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 1Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 32
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. 1,002 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 |
|---|---|---|---|---|---|---|
| Somatic delusion | 26 | 276.8 184.4–415.4ROR 277.6 · χ² 6,145 / p <1e-300 | 209.6 EB05 150.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 73% (drug 52%) | no trial data cached |
| Scedosporium infection | 61 | 229.3 176.4–298.0ROR 230.9 · χ² 12,423 / p <1e-300 | 196.2 EB05 158.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=61 | no trial data cached |
| Diaphragmatic spasm | 12 | 221.3 122.5–399.8ROR 221.6 · χ² 2,207 / p <1e-300 | 153.4 EB05 93.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Mycotic endophthalmitis | 15 | 205.4 121.2–348.1ROR 205.8 · χ² 2,621 / p <1e-300 | 152.6 EB05 98.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Trichophytosis | 15 | 179.2 106.1–302.9ROR 179.5 · χ² 2,307 / p <1e-300 | 137.8 EB05 88.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Subacute cutaneous lupus erythematosus | 76 | 106.9 85.0–134.4ROR 107.8 · χ² 7,525 / p <1e-300 | 99.8 EB05 82.3 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=76 · ♀ 80% (drug 52%) | no trial data cached |
| Erythema annulare | 12 | 103.7 58.2–184.8ROR 103.8 · χ² 1,072 / p 2e-235 | 86.2 EB05 52.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Generalised pustular psoriasis | 10 | 95.6 50.8–179.8ROR 95.7 · χ² 811 / p 1e-178 | 78.6 EB05 45.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Respiratory gas exchange disorder | 14 | 93.1 54.6–158.8ROR 93.3 · χ² 1,140 / p 3e-250 | 80.2 EB05 50.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Fusarium infection | 20 | 71.5 45.9–111.5ROR 71.7 · χ² 1,282 / p 5e-281 | 65.3 EB05 44.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Body tinea | 16 | 69.3 42.1–113.8ROR 69.4 · χ² 980 / p 2e-215 | 62.5 EB05 40.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Vancomycin infusion reaction | 10 | 67.1 35.8–125.8ROR 67.2 · χ² 570 / p 2e-126 | 58.4 EB05 33.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Urticarial vasculitis | 14 | 65.7 38.6–111.7ROR 65.8 · χ² 806 / p 1e-177 | 59.1 EB05 37.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Faecal volume decreased | 13 | 65.6 37.8–113.8ROR 65.7 · χ² 743 / p 7e-164 | 58.6 EB05 36.5 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Periostitis | 11 | 61.2 33.6–111.3ROR 61.3 · χ² 577 / p 7e-128 | 54.4 EB05 32.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Nail dystrophy | 13 | 56.9 32.8–98.6ROR 57.0 · χ² 644 / p 3e-142 | 51.6 EB05 32.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Onychomycosis | 95 | 52.6 43.0–64.4ROR 53.2 · χ² 4,656 / p <1e-300 | 51.0 EB05 43.0 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=73 | no trial data cached |
| Symmetrical drug-related intertriginous and flexural exanthema | 16 | 48.9 29.8–80.1ROR 48.9 · χ² 689 / p 5e-152 | 45.5 EB05 29.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Acute generalised exanthematous pustulosis | 155 | 48.5 41.4–56.8ROR 49.4 · χ² 7,024 / p <1e-300 | 47.3 EB05 41.4 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.5 | no trial data cached |
| Intertrigo | 10 | 45.9 24.6–85.8ROR 46.0 · χ² 388 / p 1e-86 | 41.7 EB05 24.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Pneumonia respiratory syncytial viral | 15 | 43.9 26.4–73.2ROR 44.0 · χ² 576 / p 1e-127 | 41.1 EB05 26.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Pathogen resistance | 163 | 43.3 37.1–50.5ROR 44.1 · χ² 6,572 / p <1e-300 | 42.3 EB05 37.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 33.6 · ♀ 27% (drug 52%) | no trial data cached |
| Cutaneous lupus erythematosus | 34 | 41.9 29.9–58.8ROR 42.0 · χ² 1,293 / p 2e-283 | 40.3 EB05 30.2 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=33 · ♀ 90% (drug 52%) | no trial data cached |
| Tinea infection | 19 | 41.6 26.4–65.4ROR 41.7 · χ² 700 / p 1e-154 | 39.4 EB05 26.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Chronic spontaneous urticaria | 18 | 39.4 24.7–62.7ROR 39.5 · χ² 625 / p 3e-138 | 37.4 EB05 25.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Systemic lupus erythematosus rash | 13 | 39.1 22.6–67.6ROR 39.1 · χ² 438 / p 2e-97 | 36.6 EB05 22.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Tinea pedis | 24 | 36.2 24.2–54.1ROR 36.3 · χ² 775 / p 9e-171 | 34.8 EB05 24.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 16 | 35.8 21.9–58.7ROR 35.9 · χ² 500 / p 5e-111 | 34.0 EB05 22.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Impetigo | 22 | 35.8 23.5–54.4ROR 35.8 · χ² 698 / p 4e-154 | 34.3 EB05 23.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Systemic mycosis | 16 | 33.0 20.1–54.0ROR 33.0 · χ² 458 / p 6e-102 | 31.4 EB05 20.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Ageusia (loss of taste) | 322 | 31.0 27.8–34.5ROR 32.1 · χ² 9,195 / p <1e-300 | 30.5 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 37.7 | no trial data cached |
| Fungaemia | 20 | 30.7 19.8–47.8ROR 30.8 · χ² 539 / p 2e-119 | 29.6 EB05 20.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 25% (drug 52%) · 100% clinician | no trial data cached |
| Pustular psoriasis | 44 | 30.7 22.8–41.3ROR 30.8 · χ² 1,218 / p 5e-267 | 29.9 EB05 23.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Faeces pale | 27 | 29.3 20.0–42.8ROR 29.4 · χ² 701 / p 9e-155 | 28.4 EB05 20.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 30% (drug 52%) | no trial data cached |
| Pustule | 28 | 29.2 20.2–42.4ROR 29.3 · χ² 727 / p 3e-160 | 28.4 EB05 20.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Cholestatic liver injury | 24 | 26.9 18.0–40.2ROR 27.0 · χ² 566 / p 2e-125 | 26.1 EB05 18.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Mucosal erosion | 10 | 26.5 14.2–49.3ROR 26.5 · χ² 218 / p 1e-49 | 24.9 EB05 14.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Seborrhoeic dermatitis | 17 | 24.8 15.4–40.0ROR 24.9 · χ² 361 / p 7e-81 | 24.0 EB05 15.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Xerosis | 12 | 23.5 13.3–41.5ROR 23.5 · χ² 234 / p 4e-53 | 22.4 EB05 13.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Fungal skin infection | 39 | 23.3 17.0–32.0ROR 23.4 · χ² 804 / p 4e-177 | 22.9 EB05 17.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=27 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 818 | 1.5 1.4–1.6ROR 1.5 · χ² 133 / p 4e-31 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Rash | 498 | 2.7 2.5–3.0ROR 2.8 · χ² 555 / p 6e-123 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Pruritus (itching) | 419 | 2.6 2.4–2.9ROR 2.7 · χ² 430 / p 7e-96 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Fatigue (tiredness) | 396 | 1.2 1.1–1.3ROR 1.2 · χ² 15 / p 6e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Nausea | 383 | 1.2 1.0–1.3ROR 1.2 · χ² 8 / p 0.002 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Pain | 348 | 1.3 1.2–1.5ROR 1.4 · χ² 31 / p 1e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Off label use (used outside approved label) | 339 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.082 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Ageusia (loss of taste) | 322 | 31.0 27.8–34.5ROR 32.1 · χ² 9,195 / p <1e-300 | 30.5 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 37.7 | no trial data cached |
| Headache | 306 | 1.2 1.0–1.3ROR 1.2 · χ² 7 / p 0.004 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Diarrhoea (diarrhea) | 292 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.102 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Dyspnoea (shortness of breath) | 265 | 1.1 1.0–1.3ROR 1.1 · χ² 3 / p 0.042 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Drug interaction | 261 | 3.9 3.5–4.4ROR 4.0 · χ² 566 / p 2e-125 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Malaise (feeling unwell) | 258 | 1.4 1.2–1.6ROR 1.4 · χ² 29 / p 4e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Anxiety | 256 | 2.1 1.9–2.4ROR 2.2 · χ² 155 / p 9e-36 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Dizziness | 242 | 1.2 1.0–1.3ROR 1.2 · χ² 5 / p 0.013 | 1.2 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.2 | 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.
- Somatic delusion — n=26, PRR 276.8
- Scedosporium infection — n=61, PRR 229.3
- Fusarium infection — n=20, PRR 71.5
- Tinea pedis — n=24, PRR 36.2
- Impetigo — n=22, PRR 35.8
- Ageusia — n=322, PRR 31.0
- Fungaemia — n=20, PRR 30.7
- Pustular psoriasis — n=44, PRR 30.7
- Faeces pale — n=27, PRR 29.3
- Pustule — n=28, PRR 29.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Terbinafine ↔ Taste disturbance (ageusia/dysgeusia).
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 Terbinafine?
In FDA FAERS, the most frequently co-reported reaction terms for Terbinafine are rash, pruritus, fatigue, nausea, pain, ageusia. 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 Terbinafine have an FDA boxed warning?
No. The FDA label retrieved for Terbinafine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Terbinafine 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 6dc279cc-9861-4fa8-8083-ca3b3c57b513, effective 20201029; matched on
openfda.generic_name.exact:"TERBINAFINE") - 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, 1,042 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.