Drug · FAERS side-effect profile with label screen
Clotrimazole Topical side effects: what 11,490 FDA adverse event reports show
Brand names
Clotrimazole
openFDA label
Who reports
11,490 reports · 78% serious · 927 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is in.
FDA label, Indications and Usage
What it is
DESCRIPTION Clotrimazole Topical Solution, USP 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the foll.
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. 1,120 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 |
|---|---|---|---|---|---|---|
| Pseudoaneurysm infection | 41 | 6,146.6 3,231.2–11,692.3ROR 6,168.5 · χ² 55,656 / p <1e-300 | 841.3 EB05 646.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 0% (drug 66%) · 100% clinician | no trial arm names this drug |
| Vaginal flatulence | 171 | 2,348.3 1,871.7–2,946.2ROR 2,383.7 · χ² 173,023 / p <1e-300 | 914.1 EB05 804.7 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=171 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Pulmonary vasculitis | 174 | 899.5 750.5–1,078.0ROR 913.3 · χ² 103,514 / p <1e-300 | 562.7 EB05 495.9 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=174 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Total lung capacity abnormal | 115 | 792.7 637.0–986.3ROR 800.7 · χ² 62,569 / p <1e-300 | 504.1 EB05 431.4 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Capillaritis | 64 | 572.8 432.6–758.5ROR 576.0 · χ² 27,277 / p <1e-300 | 384.6 EB05 311.8 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Vascular pseudoaneurysm ruptured | 45 | 440.0 317.8–609.2ROR 441.7 · χ² 15,485 / p <1e-300 | 307.5 EB05 239.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 0% (drug 66%) · 100% clinician | no trial arm names this drug |
| Spirometry abnormal | 109 | 416.3 338.3–512.3ROR 420.3 · χ² 36,339 / p <1e-300 | 319.3 EB05 272.1 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=109 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Mite allergy | 114 | 397.5 324.8–486.4ROR 401.4 · χ² 36,601 / p <1e-300 | 308.8 EB05 264.1 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Persistent genital arousal disorder | 39 | 367.3 260.4–518.1ROR 368.6 · χ² 11,530 / p <1e-300 | 265.5 EB05 202.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 100% (drug 66%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 100 | 290.6 235.5–358.7ROR 293.2 · χ² 24,601 / p <1e-300 | 238.9 EB05 202.1 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=100 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Mycotic allergy | 113 | 282.7 232.1–344.5ROR 285.5 · χ² 27,173 / p <1e-300 | 234.8 EB05 200.6 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=113 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Dust allergy | 115 | 247.2 203.6–300.1ROR 249.7 · χ² 24,574 / p <1e-300 | 209.9 EB05 179.6 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Schizoaffective disorder | 213 | 246.1 213.5–283.7ROR 250.7 · χ² 45,527 / p <1e-300 | 212.5 EB05 189.6 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=213 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Neuritis | 174 | 232.7 198.9–272.3ROR 236.3 · χ² 35,347 / p <1e-300 | 201.6 EB05 177.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=174 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Female genital tract fistula | 180 | 213.2 182.9–248.5ROR 216.6 · χ² 33,799 / p <1e-300 | 186.9 EB05 165.1 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=180 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Purpura senile | 12 | 203.7 112.1–369.9ROR 203.9 · χ² 1,996 / p <1e-300 | 142.2 EB05 86.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial arm names this drug |
| Sinus rhythm | 44 | 203.5 149.1–277.8ROR 204.3 · χ² 7,784 / p <1e-300 | 169.6 EB05 131.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 66%) · 100% clinician | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 160 | 157.0 133.7–184.4ROR 159.2 · χ² 22,673 / p <1e-300 | 142.1 EB05 124.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=160 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Conjunctivitis allergic | 115 | 155.7 128.8–188.2ROR 157.2 · χ² 16,124 / p <1e-300 | 140.1 EB05 119.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Macular degeneration | 812 | 133.4 124.5–142.9ROR 143.5 · χ² 99,282 / p <1e-300 | 123.9 EB05 116.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.5 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Radiculopathy | 179 | 132.8 114.3–154.5ROR 134.9 · χ² 21,692 / p <1e-300 | 122.2 EB05 107.9 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=179 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Chronic sinusitis | 248 | 129.3 113.8–146.9ROR 132.1 · χ² 29,345 / p <1e-300 | 119.6 EB05 107.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=248 · ♀ 99% (drug 66%) | no trial arm names this drug |
| Proctitis | 173 | 119.9 102.9–139.7ROR 121.7 · χ² 19,020 / p <1e-300 | 111.1 EB05 97.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=173 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Respiratory symptom | 167 | 115.6 99.0–135.1ROR 117.3 · χ² 17,728 / p <1e-300 | 107.4 EB05 94.4 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=167 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Tarsal tunnel syndrome | 11 | 95.6 52.1–175.3ROR 95.7 · χ² 890 / p 8e-196 | 78.8 EB05 47.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial arm names this drug |
| Forced expiratory volume decreased | 117 | 78.5 65.3–94.3ROR 79.2 · χ² 8,499 / p <1e-300 | 74.3 EB05 63.7 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=117 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Toxic shock syndrome | 25 | 75.0 50.3–111.8ROR 75.1 · χ² 1,681 / p <1e-300 | 68.4 EB05 48.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Normochromic normocytic anaemia | 118 | 74.6 62.1–89.6ROR 75.4 · χ² 8,159 / p <1e-300 | 70.9 EB05 60.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Retroperitoneal abscess | 12 | 72.9 41.0–129.9ROR 73.0 · χ² 750 / p 2e-165 | 63.4 EB05 38.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial arm names this drug |
| Endocrine ophthalmopathy | 29 | 66.3 45.8–96.0ROR 66.5 · χ² 1,736 / p <1e-300 | 61.5 EB05 44.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Pulmonary alveolar haemorrhage | 179 | 60.2 51.9–69.8ROR 61.1 · χ² 10,029 / p <1e-300 | 57.9 EB05 51.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=179 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Neurological symptom | 173 | 57.3 49.3–66.6ROR 58.2 · χ² 9,228 / p <1e-300 | 55.3 EB05 48.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=173 · ♀ 0% (drug 66%) | no trial arm names this drug |
| Tenosynovitis stenosans | 17 | 57.2 35.3–92.6ROR 57.2 · χ² 856 / p 2e-188 | 52.4 EB05 34.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial arm names this drug |
| Eye infection toxoplasmal | 11 | 51.5 28.3–93.8ROR 51.6 · χ² 482 / p 4e-107 | 46.4 EB05 27.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial arm names this drug |
| Vulvovaginal candidiasis | 35 | 49.1 35.1–68.7ROR 49.3 · χ² 1,559 / p <1e-300 | 46.7 EB05 35.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Arterial haemorrhage | 30 | 48.9 34.0–70.2ROR 49.0 · χ² 1,324 / p 4e-290 | 46.3 EB05 34.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 66%) · 100% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 28 | 48.7 33.5–70.9ROR 48.8 · χ² 1,228 / p 2e-269 | 46.1 EB05 33.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 | no trial arm names this drug |
| Cleft palate | 42 | 40.4 29.8–54.9ROR 40.6 · χ² 1,542 / p <1e-300 | 38.9 EB05 30.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · 100% clinician | no trial arm names this drug |
| Oral candidiasis (oral thrush) | 264 | 37.8 33.5–42.6ROR 38.6 · χ² 9,224 / p <1e-300 | 36.9 EB05 33.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.1 · ♀ 91% (drug 66%) | no trial arm names this drug |
| Arteriosclerosis coronary artery | 132 | 37.2 31.3–44.1ROR 37.6 · χ² 4,518 / p <1e-300 | 36.3 EB05 31.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=132 · ♀ 9% (drug 66%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Clotrimazole Topical only as a background or rescue medication (NCT01302119, NCT01270971); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 1,368 | 1.9 1.8–2.0ROR 2.0 · χ² 617 / p 2e-136 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.3 · ♀ 86% (drug 66%) | no trial arm names this drug |
| Macular degeneration | 812 | 133.4 124.5–142.9ROR 143.5 · χ² 99,282 / p <1e-300 | 123.9 EB05 116.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.5 · ♀ 100% (drug 66%) | no trial arm names this drug |
| Nausea | 811 | 1.9 1.8–2.0ROR 1.9 · χ² 343 / p 6e-77 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Pain | 778 | 2.3 2.2–2.5ROR 2.4 · χ² 592 / p 4e-131 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Off label use (used outside approved label) | 743 | 1.6 1.5–1.7ROR 1.6 · χ² 156 / p 4e-36 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | no trial arm names this drug |
| Headache | 735 | 2.1 2.0–2.3ROR 2.2 · χ² 460 / p 3e-102 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 705 | 2.3 2.1–2.4ROR 2.4 · χ² 516 / p 2e-114 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Fatigue (tiredness) | 640 | 1.5 1.4–1.6ROR 1.5 · χ² 111 / p 3e-26 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 598 | 1.7 1.6–1.8ROR 1.7 · χ² 176 / p 2e-40 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial arm names this drug |
| Pyrexia (fever) | 526 | 2.8 2.6–3.0ROR 2.9 · χ² 604 / p 1e-133 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial arm names this drug |
| Malaise (feeling unwell) | 478 | 2.0 1.8–2.2ROR 2.0 · χ² 237 / p 8e-54 | 2.0 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · ♀ 87% (drug 66%) | no trial arm names this drug |
| Weight decreased (weight loss) | 463 | 3.0 2.8–3.3ROR 3.1 · χ² 635 / p 2e-140 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
| Anxiety | 458 | 2.9 2.7–3.2ROR 3.0 · χ² 588 / p 3e-130 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 · ♀ 38% (drug 66%) | no trial arm names this drug |
| Rash | 457 | 1.9 1.8–2.1ROR 2.0 · χ² 206 / p 6e-47 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Therapeutic product effect incomplete | 438 | 11.4 10.4–12.5ROR 11.8 · χ² 4,117 / p <1e-300 | 11.3 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 | no trial arm names this drug |
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.
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 Clotrimazole Topical?
In FDA FAERS, the most frequently co-reported reaction terms for Clotrimazole Topical are macular degeneration, nausea, pain, headache, dyspnoea, fatigue. 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 Clotrimazole Topical have an FDA boxed warning?
No. The FDA label retrieved for Clotrimazole Topical has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clotrimazole Topical 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 02df90b9-4879-4e73-b03a-0e96f3d099ea, effective 20200813; matched on
openfda.generic_name.exact:"CLOTRIMAZOLE TOPICAL" 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, 1,160 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
CLOTRIMAZOLE TOPICAL, 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.