Drug · FAERS side-effect profile with label screen
Terbinafine side effects: what 7,123 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,123 reports · 81% serious · 444 with death outcome · 51% 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 8Labeled (related wording) 5Reporting / coding artifact 4Not in label — unassessed 23
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.
- 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.
- 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. 344 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 |
|---|---|---|---|---|---|---|
| Ageusia (loss of taste) | 273 | 32.5 28.9–36.5ROR 33.7 · χ² 8,214 / p <1e-300 | 32.1 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 40.0 | no trial data cached |
| Drug resistance | 203 | 23.4 20.5–26.9ROR 24.1 · χ² 4,309 / p <1e-300 | 23.2 EB05 20.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 · ♀ 30% (drug 51%) | no trial data cached |
| Erythema multiforme | 39 | 12.4 9.0–16.9ROR 12.4 · χ² 394 / p 5e-88 | 12.0 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Drug-induced liver injury | 102 | 9.8 8.0–11.8ROR 9.9 · χ² 792 / p 2e-174 | 9.5 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 94% clinician | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 53 | 9.5 7.3–12.4ROR 9.6 · χ² 394 / p 6e-88 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 | no trial data cached |
| Toxic skin eruption | 32 | 9.3 6.6–13.2ROR 9.4 · χ² 230 / p 4e-52 | 8.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 91% clinician | no trial data cached |
| Chromaturia | 64 | 8.4 6.5–10.7ROR 8.4 · χ² 407 / p 1e-90 | 8.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Chronic kidney disease | 198 | 7.6 6.6–8.7ROR 7.8 · χ² 1,133 / p 1e-248 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Anhedonia | 68 | 7.6 6.0–9.6ROR 7.6 · χ² 381 / p 4e-85 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 27% (drug 51%) | no trial data cached |
| End stage renal disease | 47 | 7.5 5.7–10.0ROR 7.6 · χ² 259 / p 1e-58 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Lip swelling | 84 | 7.5 6.0–9.2ROR 7.5 · χ² 463 / p 6e-103 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 89% (drug 51%) | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 68 | 7.4 5.9–9.4ROR 7.5 · χ² 372 / p 4e-83 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 94% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 48 | 7.4 5.6–9.8ROR 7.5 · χ² 259 / p 1e-58 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 100% clinician | no trial data cached |
| Liver function test abnormal | 73 | 7.4 5.9–9.2ROR 7.4 · χ² 394 / p 5e-88 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 93% clinician | no trial data cached |
| Oral discomfort | 34 | 7.2 5.1–10.1ROR 7.2 · χ² 175 / p 3e-40 | 6.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 88% (drug 51%) | no trial data cached |
| Anosmia (loss of smell) | 35 | 7.1 5.1–9.9ROR 7.1 · χ² 178 / p 8e-41 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Dysgeusia (altered taste) | 175 | 6.9 6.0–8.0ROR 7.1 · χ² 880 / p 1e-193 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 83% (drug 51%) | no trial data cached |
| Skin lesion | 61 | 6.6 5.1–8.5ROR 6.7 · χ² 284 / p 4e-64 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Rash maculo-papular | 48 | 6.4 4.8–8.5ROR 6.4 · χ² 212 / p 2e-48 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 73% (drug 51%) · 100% clinician | no trial data cached |
| Fungal infection | 72 | 6.4 5.1–8.0ROR 6.4 · χ² 321 / p 5e-72 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Rash erythematous | 100 | 6.3 5.2–7.6ROR 6.4 · χ² 440 / p 6e-98 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Economic problem | 32 | 6.1 4.3–8.7ROR 6.1 · χ² 132 / p 8e-31 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Dermatitis | 41 | 5.8 4.3–7.9ROR 5.9 · χ² 159 / p 8e-37 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 42 | 5.6 4.1–7.5ROR 5.6 · χ² 152 / p 3e-35 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 95% clinician | no trial data cached |
| Sinus bradycardia | 18 | 5.5 3.5–8.7ROR 5.5 · χ² 61 / p 2e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 28 | 5.5 3.8–7.9ROR 5.5 · χ² 98 / p 2e-23 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 92% clinician | no trial data cached |
| Dermatitis allergic | 23 | 5.4 3.6–8.2ROR 5.5 · χ² 79 / p 3e-19 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Treatment failure | 150 | 5.4 4.6–6.3ROR 5.5 · χ² 533 / p 4e-118 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Drug eruption | 32 | 5.4 3.8–7.6ROR 5.4 · χ² 109 / p 9e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 · 94% clinician | no trial data cached |
| Hepatocellular injury | 25 | 5.2 3.5–7.7ROR 5.2 · χ² 80 / p 2e-19 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 80% (drug 51%) | no trial data cached |
| Rash generalised | 45 | 5.0 3.8–6.8ROR 5.1 · χ² 142 / p 5e-33 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Renal tubular necrosis | 16 | 4.8 2.9–7.8ROR 4.8 · χ² 44 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Liver injury | 39 | 4.8 3.5–6.5ROR 4.8 · χ² 112 / p 2e-26 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · ♀ 23% (drug 51%) | no trial data cached |
| Skin exfoliation | 133 | 4.7 4.0–5.6ROR 4.8 · χ² 387 / p 2e-86 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Sputum discoloured | 15 | 4.7 2.8–7.8ROR 4.7 · χ² 40 / p 1e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Osteopenia | 24 | 4.6 3.1–6.9ROR 4.6 · χ² 65 / p 4e-16 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 26% (drug 51%) | no trial data cached |
| Rash macular | 54 | 4.6 3.5–6.0ROR 4.6 · χ² 147 / p 4e-34 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Acute hepatic failure | 21 | 4.5 3.0–7.0ROR 4.6 · χ² 55 / p 7e-14 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 95% clinician | no trial data cached |
| Ischaemic stroke | 27 | 4.5 3.1–6.5ROR 4.5 · χ² 69 / p 5e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 100% clinician | no trial data cached |
| Swollen tongue | 47 | 4.4 3.3–5.9ROR 4.5 · χ² 121 / p 2e-28 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 100% (drug 51%) | 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) | 705 | 1.6 1.5–1.7ROR 1.6 · χ² 158 / p 2e-36 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Rash | 408 | 2.8 2.5–3.0ROR 2.9 · χ² 469 / p 2e-104 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Pruritus (itching) | 330 | 2.6 2.3–2.9ROR 2.6 · χ² 321 / p 5e-72 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Pain | 274 | 1.3 1.2–1.5ROR 1.3 · χ² 20 / p 3e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Ageusia (loss of taste) | 273 | 32.5 28.9–36.5ROR 33.7 · χ² 8,214 / p <1e-300 | 32.1 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 40.0 | no trial data cached |
| Drug interaction | 230 | 4.3 3.8–4.9ROR 4.4 · χ² 576 / p 1e-127 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Malaise (feeling unwell) | 220 | 1.5 1.3–1.7ROR 1.5 · χ² 34 / p 3e-9 | 1.5 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Drug resistance | 203 | 23.4 20.5–26.9ROR 24.1 · χ² 4,309 / p <1e-300 | 23.2 EB05 20.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 · ♀ 30% (drug 51%) | no trial data cached |
| Anxiety | 202 | 2.1 1.8–2.4ROR 2.1 · χ² 114 / p 5e-27 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Chronic kidney disease | 198 | 7.6 6.6–8.7ROR 7.8 · χ² 1,133 / p 1e-248 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Product use in unapproved indication | 194 | 2.3 2.0–2.7ROR 2.4 · χ² 149 / p 2e-34 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Condition aggravated | 192 | 1.9 1.6–2.2ROR 1.9 · χ² 78 / p 5e-19 | 1.9 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 187 | 3.6 3.1–4.2ROR 3.7 · χ² 354 / p 4e-79 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Arthralgia (joint pain) | 184 | 1.3 1.1–1.5ROR 1.3 · χ² 13 / p 1e-4 | 1.3 EB05 1.2 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Dysgeusia (altered taste) | 175 | 6.9 6.0–8.0ROR 7.1 · χ² 880 / p 1e-193 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 83% (drug 51%) | 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.
- Ageusia — n=273, PRR 32.5
- Drug-induced liver injury — n=102, PRR 9.8
- Chromaturia — n=64, PRR 8.4
- Chronic kidney disease — n=198, PRR 7.6
- Anhedonia — n=68, PRR 7.6
- End stage renal disease — n=47, PRR 7.5
- Lip swelling — n=84, PRR 7.5
- Oral discomfort — n=34, PRR 7.2
- Anosmia — n=35, PRR 7.1
- Dysgeusia — n=175, PRR 6.9
✓ 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, pain, ageusia, malaise, anxiety. 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, 384 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.