Clotrimazole and Betamethasone Dipropionate side effects: what 428 FDA adverse event reports show

Clotrimazole And Betamethasone Dipropionate · 6 reaction terms · 86 drug–reaction co-reports · data 2026-09-14

Drug class

Azole Antifungal

FDA label (Established Pharmacologic Class) · compare the class

Who reports

428 reports · 57% serious · 34 with death outcome · 60% 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 6 strongest signals

Reporting / coding artifact 1Lab value / disease marker 1No label text to screen 4

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Chronic kidney disease	55	35.2 27.5–45.0ROR 40.2 · χ² 1,798 / p <1e-300	34.8 EB05 27.7 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.9	no trial data cached
Full blood count abnormal	7	32.5 15.6–67.9ROR 33.1 · χ² 184 / p 4e-42	29.8 EB05 15.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 43.4	no trial data cached
Obstructive airways disorder	5	22.0 9.2–52.5ROR 22.2 · χ² 80 / p 2e-19	17.8 EB05 5.7 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9	no trial data cached
Vasculitis	5	21.0 8.8–50.2ROR 21.3 · χ² 76 / p 1e-18	16.8 EB05 5.3 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Sleep disorder due to a general medical condition	6	18.2 8.2–40.3ROR 18.4 · χ² 81 / p 1e-19	14.9 EB05 5.4 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.2	no trial data cached
Drug dependence	8	2.4 1.2–4.8ROR 2.4 · χ² 5 / p 0.011	2.2 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Chronic kidney disease	55	35.2 27.5–45.0ROR 40.2 · χ² 1,798 / p <1e-300	34.8 EB05 27.7 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.9	no trial data cached
Drug dependence	8	2.4 1.2–4.8ROR 2.4 · χ² 5 / p 0.011	2.2 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Full blood count abnormal	7	32.5 15.6–67.9ROR 33.1 · χ² 184 / p 4e-42	29.8 EB05 15.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 43.4	no trial data cached
Sleep disorder due to a general medical condition	6	18.2 8.2–40.3ROR 18.4 · χ² 81 / p 1e-19	14.9 EB05 5.4 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.2	no trial data cached
Vasculitis	5	21.0 8.8–50.2ROR 21.3 · χ² 76 / p 1e-18	16.8 EB05 5.3 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Obstructive airways disorder	5	22.0 9.2–52.5ROR 22.2 · χ² 80 / p 2e-19	17.8 EB05 5.7 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9	no trial data cached

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 chronic kidney disease, full blood count abnormal, sleep disorder due to a general medical condition, vasculitis, obstructive airways disorder. 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, field patient.drug.openfda.generic_name.exact, 6 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

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.