Drug · FAERS side-effect profile with label screen
Clotrimazole side effects: what 12,204 FDA adverse event reports show
Who reports
12,204 reports · 77% serious · 1,001 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole lozenges are also indicated prophylactically to reduce the incide.
FDA label, Indications and Usage
What it is
DESCRIPTION Each clotrimazole lozenge contains 10 mg clotrimazole [1-(o-chloro-α, α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula:
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. 1,125 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 | 5,786.4 3,041.9–11,007.4ROR 5,805.9 · χ² 52,395 / p <1e-300 | 810.9 EB05 623.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Vaginal flatulence | 171 | 2,210.7 1,762.0–2,773.8ROR 2,242.1 · χ² 162,878 / p <1e-300 | 865.8 EB05 762.2 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=171 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Pulmonary vasculitis | 174 | 846.8 706.5–1,014.9ROR 859.0 · χ² 97,436 / p <1e-300 | 531.7 EB05 468.6 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=174 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Total lung capacity abnormal | 115 | 746.2 599.7–928.6ROR 753.3 · χ² 58,894 / p <1e-300 | 477.0 EB05 408.2 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Capillaritis | 64 | 539.3 407.3–714.0ROR 542.1 · χ² 25,674 / p <1e-300 | 364.6 EB05 295.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Vascular pseudoaneurysm ruptured | 45 | 414.2 299.1–573.5ROR 415.7 · χ² 14,574 / p <1e-300 | 291.7 EB05 226.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Spirometry abnormal | 109 | 391.9 318.5–482.3ROR 395.5 · χ² 34,200 / p <1e-300 | 301.6 EB05 257.0 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=109 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Mite allergy | 114 | 374.2 305.7–458.0ROR 377.7 · χ² 34,446 / p <1e-300 | 291.6 EB05 249.4 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Persistent genital arousal disorder | 39 | 345.8 245.2–487.8ROR 346.9 · χ² 10,851 / p <1e-300 | 251.9 EB05 192.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 100 | 273.6 221.7–337.7ROR 275.9 · χ² 23,150 / p <1e-300 | 225.6 EB05 190.8 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=100 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Mycotic allergy | 113 | 266.2 218.5–324.3ROR 268.6 · χ² 25,570 / p <1e-300 | 221.6 EB05 189.3 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=113 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Dust allergy | 115 | 232.7 191.6–282.5ROR 234.9 · χ² 23,123 / p <1e-300 | 198.0 EB05 169.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Schizoaffective disorder | 213 | 231.7 201.0–267.1ROR 235.8 · χ² 42,837 / p <1e-300 | 200.3 EB05 178.7 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=213 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Neuritis | 174 | 219.1 187.3–256.3ROR 222.2 · χ² 33,258 / p <1e-300 | 190.1 EB05 167.5 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=174 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Female genital tract fistula | 180 | 200.7 172.1–234.0ROR 203.7 · χ² 31,800 / p <1e-300 | 176.2 EB05 155.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=180 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Purpura senile | 12 | 191.7 105.6–348.2ROR 191.9 · χ² 1,877 / p <1e-300 | 135.7 EB05 82.7 · 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 | 191.6 140.3–261.5ROR 192.3 · χ² 7,323 / p <1e-300 | 160.3 EB05 124.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 160 | 147.8 125.9–173.6ROR 149.8 · χ² 21,328 / p <1e-300 | 133.9 EB05 117.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=160 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Conjunctivitis allergic | 115 | 146.5 121.2–177.2ROR 147.9 · χ² 15,167 / p <1e-300 | 132.0 EB05 113.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Macular degeneration | 813 | 125.8 117.4–134.8ROR 134.7 · χ² 93,610 / p <1e-300 | 116.8 EB05 110.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.6 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Radiculopathy | 179 | 125.1 107.6–145.4ROR 126.9 · χ² 20,402 / p <1e-300 | 115.1 EB05 101.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=179 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Chronic sinusitis | 250 | 122.8 108.1–139.4ROR 125.3 · χ² 28,051 / p <1e-300 | 113.6 EB05 102.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=250 · ♀ 99% (drug 65%) | no trial arm names this drug |
| Proctitis | 173 | 112.9 96.9–131.6ROR 114.5 · χ² 17,887 / p <1e-300 | 104.7 EB05 92.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=173 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Respiratory symptom | 167 | 108.9 93.2–127.2ROR 110.4 · χ² 16,671 / p <1e-300 | 101.2 EB05 89.0 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=167 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Tarsal tunnel syndrome | 11 | 90.0 49.1–165.0ROR 90.1 · χ² 837 / p 3e-184 | 74.8 EB05 44.6 · 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 | 73.9 61.4–88.8ROR 74.6 · χ² 7,989 / p <1e-300 | 70.0 EB05 60.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=117 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Toxic shock syndrome | 25 | 70.6 47.3–105.2ROR 70.7 · χ² 1,580 / p <1e-300 | 64.6 EB05 46.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Normochromic normocytic anaemia | 118 | 70.2 58.5–84.4ROR 70.9 · χ² 7,668 / p <1e-300 | 66.8 EB05 57.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Retroperitoneal abscess | 12 | 68.7 38.6–122.2ROR 68.7 · χ² 705 / p 1e-155 | 60.0 EB05 36.6 · 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 | 62.4 43.1–90.4ROR 62.6 · χ² 1,631 / p <1e-300 | 58.0 EB05 42.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Pulmonary alveolar haemorrhage | 179 | 56.7 48.9–65.7ROR 57.5 · χ² 9,422 / p <1e-300 | 54.6 EB05 48.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=179 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Neurological symptom | 173 | 54.0 46.4–62.7ROR 54.7 · χ² 8,669 / p <1e-300 | 52.1 EB05 45.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=173 · ♀ 0% (drug 65%) | no trial arm names this drug |
| Tenosynovitis stenosans | 17 | 53.8 33.2–87.2ROR 53.9 · χ² 804 / p 4e-177 | 49.5 EB05 32.7 · 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 |
| Chronic kidney disease-mineral and bone disorder | 30 | 49.2 34.3–70.7ROR 49.4 · χ² 1,331 / p 1e-291 | 46.5 EB05 34.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 | no trial arm names this drug |
| Eye infection toxoplasmal | 11 | 48.5 26.6–88.3ROR 48.6 · χ² 452 / p 1e-100 | 43.9 EB05 26.1 · IC025 +2.9 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 | 46.2 33.1–64.7ROR 46.4 · χ² 1,464 / p <1e-300 | 44.0 EB05 33.1 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Arterial haemorrhage | 30 | 46.0 32.0–66.1ROR 46.1 · χ² 1,243 / p 1e-272 | 43.7 EB05 32.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Cleft palate | 42 | 38.1 28.1–51.7ROR 38.2 · χ² 1,447 / p <1e-300 | 36.7 EB05 28.3 · IC025 +4.2 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) | 269 | 36.2 32.2–40.8ROR 37.0 · χ² 8,996 / p <1e-300 | 35.4 EB05 32.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.9 · ♀ 90% (drug 65%) | no trial arm names this drug |
| Hyperparathyroidism secondary | 52 | 36.0 27.4–47.3ROR 36.1 · χ² 1,698 / p <1e-300 | 34.9 EB05 27.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Clotrimazole only as a background or rescue medication (NCT02515656, NCT01302119); 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) | 1,407 | 1.8 1.7–1.9ROR 1.9 · χ² 570 / p 3e-126 | 1.8 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.1 · ♀ 85% (drug 65%) | no trial arm names this drug |
| Nausea | 857 | 1.9 1.7–2.0ROR 1.9 · χ² 357 / p 7e-80 | 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 | 816 | 2.3 2.1–2.4ROR 2.4 · χ² 601 / p 4e-133 | 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 2.3 | no trial arm names this drug |
| Macular degeneration | 813 | 125.8 117.4–134.8ROR 134.7 · χ² 93,610 / p <1e-300 | 116.8 EB05 110.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.6 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Headache | 772 | 2.1 2.0–2.3ROR 2.2 · χ² 468 / p 4e-104 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 765 | 1.5 1.4–1.6ROR 1.5 · χ² 139 / p 3e-32 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 759 | 2.3 2.2–2.5ROR 2.4 · χ² 575 / p 2e-127 | 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 2.1 | no trial arm names this drug |
| Fatigue (tiredness) | 689 | 1.5 1.4–1.6ROR 1.6 · χ² 128 / p 5e-30 | 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) | 644 | 1.7 1.6–1.9ROR 1.8 · χ² 199 / p 1e-45 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial arm names this drug |
| Pyrexia (fever) | 548 | 2.7 2.5–3.0ROR 2.8 · χ² 604 / p 1e-133 | 2.7 EB05 2.5 · IC025 +1.3 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 |
| Malaise (feeling unwell) | 494 | 1.9 1.8–2.1ROR 2.0 · χ² 225 / p 3e-51 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · ♀ 87% (drug 65%) | no trial arm names this drug |
| Rash | 487 | 1.9 1.8–2.1ROR 2.0 · χ² 222 / p 2e-50 | 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 |
| Weight decreased (weight loss) | 487 | 3.0 2.8–3.3ROR 3.1 · χ² 655 / p 8e-145 | 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 | 485 | 2.9 2.7–3.2ROR 3.0 · χ² 619 / p 6e-137 | 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 65%) | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 455 | 5.1 4.7–5.6ROR 5.3 · χ² 1,521 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Clotrimazole are nausea, pain, macular degeneration, 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 have an FDA boxed warning?
No. The FDA label retrieved for Clotrimazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clotrimazole 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 3f57ef51-8202-4d0b-95a8-d2df468b8d9a, effective 20220531; matched on
openfda.generic_name.exact:"CLOTRIMAZOLE" 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, 1,165 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, 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.