Drug · FAERS side-effect profile with label screen
Ketoconazole Cream and 2% side effects: what 14,750 FDA adverse event reports show
Drug class
Azole Antifungal
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Ketoconazole Cream (Ketoconazole Cream)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
14,750 reports · 54% serious · 931 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
FDA label, Indications and Usage
What it is
Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueo.
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
Lab value / disease marker 3No label text to screen 37
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 1,111 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 |
|---|---|---|---|---|---|---|
| Purpura senile | 12 | 158.6 87.3–288.1ROR 158.8 · χ² 1,550 / p <1e-300 | 116.6 EB05 71.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Tarsal tunnel syndrome | 12 | 81.6 45.6–146.1ROR 81.7 · χ² 828 / p 2e-182 | 69.1 EB05 42.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Seborrhoeic dermatitis | 83 | 75.6 60.7–94.3ROR 76.0 · χ² 5,728 / p <1e-300 | 70.7 EB05 58.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 | not reported in cached trials |
| Cortisol increased | 30 | 73.6 51.0–106.2ROR 73.8 · χ² 1,973 / p <1e-300 | 67.1 EB05 49.3 · 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 | 72.7 43.3–122.2ROR 72.8 · χ² 942 / p 4e-207 | 63.8 EB05 41.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Intertrigo | 25 | 70.8 47.4–105.7ROR 70.9 · χ² 1,571 / p <1e-300 | 64.3 EB05 45.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 100% (drug 51%) | not reported in cached trials |
| Tinea versicolour | 11 | 45.5 24.9–82.9ROR 45.5 · χ² 421 / p 6e-94 | 41.2 EB05 24.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Lentigo | 13 | 38.0 21.9–66.0ROR 38.1 · χ² 421 / p 7e-94 | 35.3 EB05 21.9 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Tinea cruris | 12 | 35.4 20.0–62.8ROR 35.4 · χ² 358 / p 3e-80 | 32.9 EB05 20.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Body tinea | 13 | 33.5 19.3–58.0ROR 33.5 · χ² 369 / p 2e-82 | 31.4 EB05 19.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Dandruff | 49 | 32.3 24.3–42.8ROR 32.4 · χ² 1,421 / p <1e-300 | 31.2 EB05 24.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 · 100% consumer | not reported in cached trials |
| Seborrhoeic keratosis | 30 | 29.7 20.7–42.6ROR 29.7 · χ² 786 / p 3e-173 | 28.6 EB05 21.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 22 | 29.6 19.4–45.2ROR 29.7 · χ² 569 / p 6e-126 | 28.4 EB05 19.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | not reported in cached trials |
| Hyperparathyroidism secondary | 49 | 28.0 21.1–37.2ROR 28.1 · χ² 1,226 / p 8e-269 | 27.2 EB05 21.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 | not reported in cached trials |
| Nephrogenic anaemia | 86 | 26.6 21.5–32.9ROR 26.8 · χ² 2,056 / p <1e-300 | 26.0 EB05 21.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=86 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 16 | 25.2 15.4–41.3ROR 25.2 · χ² 342 / p 1e-76 | 24.1 EB05 15.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | not reported in cached trials |
| Tinea pedis | 27 | 24.4 16.7–35.7ROR 24.5 · χ² 573 / p 6e-127 | 23.7 EB05 17.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | NCT01110330: 3/234 (1.3%) on Ketoconazole Cream and 2%; 6/119 (5.0%) control |
| Xerosis | 20 | 23.6 15.2–36.7ROR 23.6 · χ² 404 / p 5e-90 | 22.7 EB05 15.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Otitis media acute | 12 | 23.5 13.3–41.6ROR 23.5 · χ² 233 / p 7e-53 | 22.2 EB05 13.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Pneumonia mycoplasmal | 11 | 19.9 11.0–36.1ROR 19.9 · χ² 177 / p 1e-40 | 18.6 EB05 10.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Resorption bone increased | 11 | 19.3 10.7–35.0ROR 19.3 · χ² 171 / p 2e-39 | 18.0 EB05 9.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Guttate psoriasis | 11 | 19.2 10.6–34.8ROR 19.2 · χ² 170 / p 4e-39 | 17.9 EB05 9.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Adrenal suppression | 11 | 18.8 10.3–34.0ROR 18.8 · χ² 165 / p 4e-38 | 17.4 EB05 9.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Jaw fracture | 28 | 18.6 12.8–27.0ROR 18.6 · χ² 443 / p 1e-98 | 18.1 EB05 13.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 51%) · 100% consumer | NCT01110330: 1/230 (0.4%) on Ketoconazole Cream and 2% (serious AE) |
| Impetigo | 19 | 18.4 11.7–29.0ROR 18.5 · χ² 292 / p 8e-66 | 17.8 EB05 11.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | not reported in cached trials |
| Contraindication to medical treatment | 18 | 16.9 10.6–26.8ROR 16.9 · χ² 250 / p 1e-56 | 16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Vestibular disorder | 14 | 16.4 9.7–27.8ROR 16.4 · χ² 185 / p 2e-42 | 15.4 EB05 9.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Bone demineralisation | 12 | 16.2 9.2–28.7ROR 16.2 · χ² 155 / p 8e-36 | 14.9 EB05 8.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | not reported in cached trials |
| Pustule | 24 | 15.0 10.0–22.4ROR 15.0 · χ² 296 / p 1e-66 | 14.4 EB05 9.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 51%) | not reported in cached trials |
| Pulmonary granuloma | 12 | 14.9 8.5–26.4ROR 15.0 · χ² 141 / p 8e-33 | 13.5 EB05 7.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | not reported in cached trials |
| Immunosuppressant drug level decreased | 12 | 14.5 8.2–25.5ROR 14.5 · χ² 136 / p 1e-31 | 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 9.7–21.0ROR 14.3 · χ² 305 / p 1e-68 | 13.7 EB05 9.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | not reported in cached trials |
| Hypogonadism | 10 | 14.1 7.6–26.2ROR 14.1 · χ² 108 / p 2e-25 | 12.1 EB05 6.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | not reported in cached trials |
| Rebound acid hypersecretion | 30 | 14.0 9.8–20.1ROR 14.1 · χ² 347 / p 1e-77 | 13.5 EB05 9.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 | not reported in cached trials |
| Vertigo positional | 17 | 13.9 8.7–22.5ROR 14.0 · χ² 190 / p 2e-43 | 13.0 EB05 8.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Chemical burn | 11 | 13.9 7.7–25.1ROR 13.9 · χ² 118 / p 1e-27 | 12.1 EB05 6.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | not reported in cached trials |
| Fungal skin infection | 36 | 12.9 9.3–17.9ROR 12.9 · χ² 379 / p 9e-85 | 12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | not reported in cached trials |
| Trichorrhexis | 25 | 12.8 8.7–19.0ROR 12.8 · χ² 259 / p 2e-58 | 12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | not reported in cached trials |
| Papule | 61 | 12.6 9.8–16.2ROR 12.6 · χ² 633 / p 6e-140 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 12 | 12.3 7.0–21.7ROR 12.3 · χ² 113 / p 1e-26 | 10.6 EB05 5.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | 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 Cream and 2% 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) | 1,451 | 1.6 1.5–1.6ROR 1.6 · χ² 316 / p 5e-71 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Off label use (used outside approved label) | 1,102 | 1.8 1.7–1.9ROR 1.9 · χ² 412 / p 8e-92 | 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 155 / p 6e-36 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | not reported in cached trials |
| Pruritus (itching) | 825 | 3.1 2.9–3.3ROR 3.2 · χ² 1,195 / p 3e-262 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | NCT01110330: 1/230 (0.4%) on Ketoconazole Cream and 2% |
| Rash | 746 | 2.4 2.3–2.6ROR 2.5 · χ² 649 / p 2e-143 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | NCT01110330: 2/234 (0.9%) on Ketoconazole Cream and 2%; 1/119 (0.8%) control |
| Nausea | 727 | 1.3 1.2–1.4ROR 1.3 · χ² 55 / p 6e-14 | 1.3 EB05 1.2 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT01110330: 1/230 (0.4%) on Ketoconazole Cream and 2% |
| Diarrhoea (diarrhea) | 694 | 1.5 1.4–1.6ROR 1.6 · χ² 132 / p 6e-31 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT03824912: 1/319 (0.3%) on Ketoconazole Cream and 2% |
| Headache | 647 | 1.5 1.4–1.6ROR 1.5 · χ² 99 / p 1e-23 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT03824912: 5/319 (1.6%) on Ketoconazole Cream and 2% |
| Pain | 631 | 1.5 1.4–1.6ROR 1.5 · χ² 93 / p 3e-22 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | NCT03824912: 2/319 (0.6%) on Ketoconazole Cream and 2% |
| Psoriasis | 603 | 6.6 6.1–7.1ROR 6.8 · χ² 2,852 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 554 | 1.4 1.3–1.5ROR 1.4 · χ² 62 / p 1e-15 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT01110330: 1/230 (0.4%) on Ketoconazole Cream and 2% |
| Dizziness | 537 | 1.5 1.4–1.7ROR 1.6 · χ² 101 / p 4e-24 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | NCT01110330: 1/230 (0.4%) on Ketoconazole Cream and 2% |
| Arthralgia (joint pain) | 520 | 1.8 1.6–1.9ROR 1.8 · χ² 182 / p 1e-41 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | NCT03824912: 1/156 (0.6%) control |
| Product use in unapproved indication | 517 | 3.0 2.8–3.3ROR 3.1 · χ² 699 / p 2e-154 | 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 8.3–9.9ROR 9.4 · χ² 3,500 / p <1e-300 | 9.0 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ 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 Cream and 2%?
In FDA FAERS, the most frequently co-reported reaction terms for Ketoconazole Cream and 2% 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 Cream and 2% have an FDA boxed warning?
No. The FDA label retrieved for Ketoconazole Cream and 2% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ketoconazole Cream and 2% 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 f422aaa8-3cce-5989-e053-2a95a90a5205, effective 20260317; matched on
openfda.generic_name.exact:"KETOCONAZOLE CREAM" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,151 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 CREAM, 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.