Ketoconazole side effects: what 17,202 FDA adverse event reports show
Who reports
17,202 reports · 54% serious · 1,119 with death outcome · 51% female
Used for
Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
What it is
DESCRIPTION Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.
Boxed warning
Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 1,126 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 |
|---|---|---|---|---|---|---|
| Purpura senile | 13 | 148.7 83.6–264.6ROR 148.9 · χ² 1,569 / p <1e-300 | 111.3 EB05 69.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Seborrhoeic dermatitis | 99 | 78.1 63.8–95.7ROR 78.6 · χ² 7,007 / p <1e-300 | 72.4 EB05 61.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=44 | not reported in cached trials |
| Tarsal tunnel syndrome | 13 | 76.2 43.5–133.4ROR 76.2 · χ² 838 / p 2e-184 | 65.2 EB05 40.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Intertrigo | 27 | 65.8 44.7–96.9ROR 65.9 · χ² 1,573 / p <1e-300 | 59.9 EB05 43.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 77% (drug 51%) | not reported in cached trials |
| Cortisol increased | 31 | 65.3 45.5–93.8ROR 65.5 · χ² 1,802 / p <1e-300 | 59.8 EB05 44.2 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 76% (drug 51%) | not reported in cached trials |
| Aspergillus test positive | 15 | 62.4 37.1–104.8ROR 62.4 · χ² 804 / p 5e-177 | 55.4 EB05 35.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Toxic shock syndrome | 25 | 50.1 33.6–74.7ROR 50.1 · χ² 1,107 / p 4e-243 | 46.5 EB05 33.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 100% (drug 51%) | not reported in cached trials |
| Tinea versicolour | 13 | 46.3 26.6–80.6ROR 46.4 · χ² 512 / p 9e-114 | 42.1 EB05 26.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Dandruff | 79 | 45.2 36.2–56.6ROR 45.4 · χ² 3,251 / p <1e-300 | 43.2 EB05 35.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Endocrine ophthalmopathy | 28 | 42.7 29.3–62.2ROR 42.8 · χ² 1,061 / p 5e-233 | 40.2 EB05 29.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 51%) | not reported in cached trials |
| Body tinea | 19 | 42.4 26.9–67.0ROR 42.5 · χ² 703 / p 4e-155 | 39.5 EB05 26.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Tenosynovitis stenosans | 17 | 38.2 23.6–61.9ROR 38.2 · χ² 561 / p 3e-124 | 35.7 EB05 23.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Tinea cruris | 13 | 32.9 19.0–57.2ROR 33.0 · χ² 361 / p 7e-81 | 30.8 EB05 19.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Lentigo | 13 | 32.6 18.8–56.6ROR 32.6 · χ² 358 / p 5e-80 | 30.5 EB05 18.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Seborrhoeic keratosis | 33 | 28.0 19.9–39.6ROR 28.1 · χ² 815 / p 2e-179 | 27.0 EB05 20.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 23 | 26.6 17.6–40.2ROR 26.6 · χ² 530 / p 2e-117 | 25.6 EB05 17.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Hyperparathyroidism secondary | 52 | 25.5 19.4–33.6ROR 25.6 · χ² 1,176 / p 4e-258 | 24.8 EB05 19.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Nephrogenic anaemia | 96 | 25.5 20.9–31.2ROR 25.7 · χ² 2,192 / p <1e-300 | 24.9 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=96 | not reported in cached trials |
| Nasal ulcer | 29 | 22.4 15.6–32.4ROR 22.5 · χ² 563 / p 1e-124 | 21.8 EB05 15.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 51%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 16 | 21.6 13.2–35.4ROR 21.6 · χ² 289 / p 4e-65 | 20.7 EB05 13.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Xerosis | 21 | 21.3 13.8–32.7ROR 21.3 · χ² 379 / p 1e-84 | 20.5 EB05 14.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | 100% clinician | not reported in cached trials |
| Tinea pedis | 27 | 20.9 14.3–30.6ROR 21.0 · χ² 484 / p 1e-107 | 20.3 EB05 14.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=18 | NCT01110330: 3/234 (1.3%) on Ketoconazole; 6/119 (5.0%) control |
| Arthrodesis | 16 | 19.5 11.9–31.9ROR 19.5 · χ² 258 / p 3e-58 | 18.6 EB05 11.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Mean cell haemoglobin increased | 25 | 18.6 12.5–27.6ROR 18.6 · χ² 393 / p 8e-88 | 18.0 EB05 12.7 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=25 · ♀ 100% (drug 51%) | not reported in cached trials |
| Impetigo | 22 | 18.3 12.0–27.9ROR 18.4 · χ² 338 / p 7e-76 | 17.7 EB05 12.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Eyelid disorder | 33 | 17.7 12.6–25.0ROR 17.7 · χ² 496 / p 3e-110 | 17.3 EB05 12.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 51%) | not reported in cached trials |
| Trichorrhexis | 40 | 17.7 13.0–24.2ROR 17.7 · χ² 605 / p 8e-134 | 17.3 EB05 13.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 51%) · 100% consumer | not reported in cached trials |
| Jaw fracture | 30 | 17.1 11.9–24.5ROR 17.1 · χ² 432 / p 2e-96 | 16.6 EB05 12.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 0% (drug 51%) · 100% consumer | NCT01110330: 1/230 (0.4%) on Ketoconazole (serious AE) |
| Hair texture abnormal | 184 | 16.8 14.6–19.5ROR 17.0 · χ² 2,688 / p <1e-300 | 16.6 EB05 14.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 · ♀ 82% (drug 51%) · 97% consumer | not reported in cached trials |
| Vestibular disorder | 15 | 15.1 9.1–25.1ROR 15.1 · χ² 181 / p 1e-41 | 14.0 EB05 8.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Contraindication to medical treatment | 18 | 14.5 9.1–23.0ROR 14.5 · χ² 210 / p 8e-48 | 13.6 EB05 8.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Vertigo positional | 20 | 14.1 9.1–21.9ROR 14.1 · χ² 228 / p 1e-51 | 13.3 EB05 8.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 51%) | not reported in cached trials |
| Bone demineralisation | 12 | 13.9 7.9–24.6ROR 13.9 · χ² 130 / p 2e-30 | 12.3 EB05 6.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Pulmonary granuloma | 13 | 13.9 8.0–24.0ROR 13.9 · χ² 141 / p 7e-33 | 12.5 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Pustule | 25 | 13.4 9.0–19.8ROR 13.4 · χ² 271 / p 4e-61 | 12.7 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 51%) | not reported in cached trials |
| Fungal skin infection | 42 | 12.9 9.5–17.5ROR 12.9 · χ² 445 / p 5e-99 | 12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=29 | not reported in cached trials |
| Rebound acid hypersecretion | 32 | 12.8 9.1–18.2ROR 12.9 · χ² 334 / p 7e-75 | 12.3 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Actinic keratosis | 27 | 12.7 8.7–18.6ROR 12.7 · χ² 277 / p 2e-62 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Immunosuppressant drug level decreased | 12 | 12.4 7.0–21.9ROR 12.4 · χ² 113 / p 9e-27 | 10.7 EB05 5.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 13 | 11.4 6.6–19.8ROR 11.4 · χ² 113 / p 1e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ketoconazole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT03824912 — Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedi (N=831, PHASE3; 18 AE terms posted; arms: Test: Ketoconazole Cream 2%; Reference: Ketoconazole Cream 2%; Placebo: Cream (Test Vehicle))
- NCT01110330 — An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known a (N=583, PHASE3; 97 AE terms posted; arms: Ketoconazole; Nizoral; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 1,738 | 1.6 1.5–1.7ROR 1.7 · χ² 426 / p 5e-95 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Off label use (used outside approved label) | 1,236 | 1.7 1.6–1.8ROR 1.8 · χ² 401 / p 1e-89 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Pruritus (itching) | 978 | 3.2 3.0–3.4ROR 3.3 · χ² 1,463 / p <1e-300 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT01110330: 1/230 (0.4%) on Ketoconazole |
| Fatigue (tiredness) | 976 | 1.5 1.4–1.6ROR 1.6 · χ² 186 / p 1e-42 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Nausea | 872 | 1.3 1.3–1.4ROR 1.4 · χ² 81 / p 1e-19 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT01110330: 1/230 (0.4%) on Ketoconazole |
| Rash | 855 | 2.4 2.3–2.6ROR 2.5 · χ² 714 / p 1e-157 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01110330: 2/234 (0.9%) on Ketoconazole; 1/119 (0.8%) control |
| Diarrhoea (diarrhea) | 814 | 1.5 1.4–1.6ROR 1.6 · χ² 160 / p 7e-37 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT03824912: 1/319 (0.3%) on Ketoconazole |
| Headache | 754 | 1.5 1.4–1.6ROR 1.5 · χ² 115 / p 3e-27 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT03824912: 5/319 (1.6%) on Ketoconazole |
| Pain | 749 | 1.5 1.4–1.6ROR 1.5 · χ² 121 / p 2e-28 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT03824912: 2/319 (0.6%) on Ketoconazole |
| Psoriasis | 654 | 6.1 5.7–6.6ROR 6.3 · χ² 2,800 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 640 | 1.4 1.3–1.5ROR 1.4 · χ² 68 / p 8e-17 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | NCT01110330: 1/230 (0.4%) on Ketoconazole |
| Dizziness | 615 | 1.5 1.4–1.6ROR 1.5 · χ² 106 / p 3e-25 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01110330: 1/230 (0.4%) on Ketoconazole |
| Arthralgia (joint pain) | 582 | 1.7 1.6–1.9ROR 1.7 · χ² 175 / p 3e-40 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT03824912: 1/156 (0.6%) control |
| Product use in unapproved indication | 576 | 2.9 2.7–3.1ROR 2.9 · χ² 710 / p 9e-157 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Chronic kidney disease | 521 | 8.3 7.7–9.1ROR 8.6 · χ² 3,343 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | not reported in cached trials |
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.
- Seborrhoeic dermatitis — n=99, PRR 78.1
- Intertrigo — n=27, PRR 65.8
- Dandruff — n=79, PRR 45.2
- Endocrine ophthalmopathy — n=28, PRR 42.7
- Seborrhoeic keratosis — n=33, PRR 28.0
- Chronic kidney disease-mineral and bone disorder — n=23, PRR 26.6
- Hyperparathyroidism secondary — n=52, PRR 25.5
- Nephrogenic anaemia — n=96, PRR 25.5
- Nasal ulcer — n=29, PRR 22.4
- Xerosis — n=21, PRR 21.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ketoconazole (oral) ↔ 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 Ketoconazole?
In FDA FAERS, the most frequently co-reported reaction terms for Ketoconazole are pruritus, fatigue, nausea, rash, diarrhoea, headache. 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 Ketoconazole have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Do FAERS signals prove that Ketoconazole 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 1d598696-c6f3-4b7c-ad73-949d2089df35, effective 20260810; matched on
openfda.generic_name.exact:"KETOCONAZOLE") - 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, 1,166 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 - ClinicalTrials.gov API v2 (query
KETOCONAZOLE, results-bearing studies sorted by enrollment)
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.