Ketoconazole Foam side effects: what 14,688 FDA adverse event reports show
Brand names
Ketoconazole
Who reports
14,688 reports · 54% serious · 931 with death outcome · 51% female
Used for
Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established. Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ).
What it is
Ketoconazole foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- 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. 1,110 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 | 12 | 159.3 87.7–289.3ROR 159.4 · χ² 1,556 / p <1e-300 | 117.0 EB05 71.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Tarsal tunnel syndrome | 12 | 82.0 45.8–146.7ROR 82.0 · χ² 832 / p 3e-183 | 69.3 EB05 42.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Seborrhoeic dermatitis | 82 | 75.0 60.1–93.6ROR 75.4 · χ² 5,613 / p <1e-300 | 70.1 EB05 58.3 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=33 | not reported in cached trials |
| Cortisol increased | 30 | 73.9 51.2–106.7ROR 74.1 · χ² 1,982 / p <1e-300 | 67.4 EB05 49.5 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=29 · ♀ 75% (drug 51%) | not reported in cached trials |
| Aspergillus test positive | 15 | 73.0 43.5–122.7ROR 73.1 · χ² 946 / p 5e-208 | 64.1 EB05 41.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Intertrigo | 25 | 71.1 47.6–106.2ROR 71.2 · χ² 1,578 / p <1e-300 | 64.5 EB05 46.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 51%) | not reported in cached trials |
| Tinea versicolour | 11 | 45.7 25.1–83.2ROR 45.7 · χ² 423 / p 3e-94 | 41.3 EB05 24.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Lentigo | 13 | 38.2 22.0–66.2ROR 38.2 · χ² 423 / p 3e-94 | 35.4 EB05 22.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Tinea cruris | 12 | 35.5 20.1–63.0ROR 35.6 · χ² 360 / p 1e-80 | 33.0 EB05 20.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Body tinea | 13 | 33.6 19.4–58.3ROR 33.7 · χ² 371 / p 7e-83 | 31.5 EB05 19.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Dandruff | 49 | 32.4 24.4–43.0ROR 32.5 · χ² 1,427 / p <1e-300 | 31.3 EB05 24.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=9 · 100% consumer | not reported in cached trials |
| Seborrhoeic keratosis | 30 | 29.8 20.8–42.8ROR 29.9 · χ² 790 / p 5e-174 | 28.7 EB05 21.1 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 22 | 29.8 19.5–45.4ROR 29.8 · χ² 571 / p 2e-126 | 28.5 EB05 19.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Hyperparathyroidism secondary | 49 | 28.1 21.2–37.3ROR 28.2 · χ² 1,231 / p 5e-270 | 27.4 EB05 21.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=49 | not reported in cached trials |
| Nephrogenic anaemia | 86 | 26.7 21.6–33.1ROR 26.9 · χ² 2,065 / p <1e-300 | 26.1 EB05 21.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=86 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 16 | 25.3 15.5–41.5ROR 25.4 · χ² 344 / p 5e-77 | 24.2 EB05 15.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Xerosis | 20 | 23.7 15.2–36.8ROR 23.7 · χ² 405 / p 2e-90 | 22.8 EB05 15.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Otitis media acute | 12 | 23.6 13.4–41.8ROR 23.6 · χ² 234 / p 4e-53 | 22.3 EB05 13.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Tinea pedis | 24 | 21.7 14.5–32.5ROR 21.8 · χ² 448 / p 1e-99 | 21.1 EB05 14.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Pneumonia mycoplasmal | 11 | 20.0 11.0–36.3ROR 20.0 · χ² 177 / p 9e-41 | 18.7 EB05 10.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Resorption bone increased | 11 | 19.4 10.7–35.2ROR 19.4 · χ² 172 / p 2e-39 | 18.1 EB05 10.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Guttate psoriasis | 11 | 19.3 10.6–34.9ROR 19.3 · χ² 170 / p 3e-39 | 18.0 EB05 9.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Adrenal suppression | 11 | 18.8 10.4–34.1ROR 18.8 · χ² 166 / p 3e-38 | 17.5 EB05 9.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Jaw fracture | 28 | 18.7 12.9–27.1ROR 18.7 · χ² 445 / p 5e-99 | 18.2 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 51%) · 100% consumer | not reported in cached trials |
| Impetigo | 19 | 18.5 11.8–29.1ROR 18.5 · χ² 294 / p 4e-66 | 17.8 EB05 11.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Contraindication to medical treatment | 18 | 16.9 10.6–27.0ROR 17.0 · χ² 251 / p 7e-57 | 16.2 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Vestibular disorder | 14 | 16.5 9.7–27.9ROR 16.5 · χ² 186 / p 1e-42 | 15.4 EB05 9.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Bone demineralisation | 12 | 16.3 9.2–28.8ROR 16.3 · χ² 156 / p 5e-36 | 15.0 EB05 8.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Pustule | 24 | 15.0 10.1–22.5ROR 15.1 · χ² 297 / p 6e-67 | 14.4 EB05 9.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 51%) | not reported in cached trials |
| Pulmonary granuloma | 12 | 15.0 8.5–26.5ROR 15.0 · χ² 142 / p 6e-33 | 13.6 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Immunosuppressant drug level decreased | 12 | 14.5 8.2–25.6ROR 14.5 · χ² 136 / p 8e-32 | 13.0 EB05 7.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Actinic keratosis | 26 | 14.3 9.7–21.1ROR 14.4 · χ² 306 / p 7e-69 | 13.8 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Hypogonadism | 10 | 14.1 7.6–26.4ROR 14.2 · χ² 108 / p 1e-25 | 12.2 EB05 6.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Rebound acid hypersecretion | 30 | 14.1 9.8–20.2ROR 14.1 · χ² 348 / p 5e-78 | 13.6 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Vertigo positional | 17 | 14.0 8.7–22.6ROR 14.0 · χ² 191 / p 1e-43 | 13.0 EB05 8.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Chemical burn | 11 | 13.9 7.7–25.2ROR 14.0 · χ² 118 / p 7e-28 | 12.2 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Fungal skin infection | 36 | 12.9 9.3–18.0ROR 13.0 · χ² 381 / p 3e-85 | 12.5 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Papule | 61 | 12.6 9.8–16.2ROR 12.7 · χ² 636 / p 1e-140 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 12 | 12.4 7.0–21.8ROR 12.4 · χ² 113 / p 1e-26 | 10.6 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Trichorrhexis | 24 | 12.4 8.3–18.5ROR 12.4 · χ² 237 / p 8e-54 | 11.6 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | 100% consumer | 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 Foam 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 (0 of 40 signal terms matched).
- NCT00703846 — STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% (N=498, PHASE4; 23 AE terms posted; arms: Extina (Ketoconazole) 2%)
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) | 1,427 | 1.5 1.5–1.6ROR 1.6 · χ² 294 / p 4e-66 | 1.5 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Off label use (used outside approved label) | 1,104 | 1.8 1.7–1.9ROR 1.9 · χ² 421 / p 7e-94 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Fatigue (tiredness) | 833 | 1.5 1.4–1.6ROR 1.6 · χ² 158 / p 1e-36 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Pruritus (itching) | 821 | 3.1 2.9–3.3ROR 3.2 · χ² 1,188 / p 1e-260 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Rash | 743 | 2.4 2.3–2.6ROR 2.5 · χ² 647 / p 5e-143 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Nausea | 726 | 1.3 1.2–1.4ROR 1.3 · χ² 56 / p 4e-14 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | not reported in cached trials |
| Diarrhoea (diarrhea) | 694 | 1.5 1.4–1.7ROR 1.6 · χ² 135 / p 2e-31 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | not reported in cached trials |
| Headache | 647 | 1.5 1.4–1.6ROR 1.5 · χ² 101 / p 4e-24 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | NCT00703846: 32/498 (6.4%) on Ketoconazole Foam |
| Pain | 628 | 1.5 1.3–1.6ROR 1.5 · χ² 92 / p 4e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.8 | not reported in cached trials |
| Psoriasis | 603 | 6.6 6.1–7.1ROR 6.8 · χ² 2,868 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 553 | 1.4 1.3–1.5ROR 1.4 · χ² 63 / p 9e-16 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | not reported in cached trials |
| Dizziness | 536 | 1.5 1.4–1.7ROR 1.6 · χ² 102 / p 2e-24 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Arthralgia (joint pain) | 520 | 1.8 1.6–1.9ROR 1.8 · χ² 185 / p 2e-42 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Product use in unapproved indication | 518 | 3.0 2.8–3.3ROR 3.1 · χ² 709 / p 1e-156 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | not reported in cached trials |
| Chronic kidney disease | 488 | 9.1 8.4–10.0ROR 9.4 · χ² 3,518 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | 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.
- Intertrigo — n=25, PRR 71.1
- Dandruff — n=49, PRR 32.4
- Chronic kidney disease-mineral and bone disorder — n=22, PRR 29.8
- Hyperparathyroidism secondary — n=49, PRR 28.1
- Nephrogenic anaemia — n=86, PRR 26.7
- Xerosis — n=20, PRR 23.7
- Tinea pedis — n=24, PRR 21.7
- Jaw fracture — n=28, PRR 18.7
- Pustule — n=24, PRR 15.0
- Actinic keratosis — n=26, PRR 14.3
✓ 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 Foam?
In FDA FAERS, the most frequently co-reported reaction terms for Ketoconazole Foam are fatigue, pruritus, rash, nausea, 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 Foam have an FDA boxed warning?
No. The FDA label retrieved for Ketoconazole Foam has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ketoconazole Foam 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 ea319889-5e58-f778-3009-5ba6a5f2690a, effective 20190923; matched on
openfda.generic_name.exact:"KETOCONAZOLE FOAM") - 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, 1,150 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 FOAM, 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.