Ciclopirox Olamine side effects: what 470 FDA adverse event reports show

Ciclopirox Olamine · 11 reaction terms · 202 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

470 reports · 66% serious · 15 with death outcome · 39% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

FDA label, Indications and Usage

What it is

DESCRIPTION Ciclopirox Olamine Cream USP, 1.0% is for topical use. Each gram of ciclopirox olamine cream contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water mis.

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 7 strongest signals

Reporting / coding artifact 4No label text to screen 3

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.
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. 4 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
Device dislocation	78	80.3 65.6–98.4ROR 96.1 · χ² 6,033 / p <1e-300	78.7 EB05 65.1 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 91.7 · ♀ 0% (drug 39%)	no trial data cached
Device malfunction	78	51.8 42.3–63.5ROR 62.0 · χ² 3,847 / p <1e-300	51.2 EB05 42.3 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 227.8 · ♀ 0% (drug 39%)	no trial data cached
Tendon rupture (torn tendon)	9	32.5 17.0–62.0ROR 33.1 · χ² 244 / p 3e-55	30.5 EB05 17.0 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.0	no trial data cached
Therapy partial responder	7	20.7 9.9–43.3ROR 21.0 · χ² 113 / p 1e-26	18.4 EB05 7.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.8	no trial data cached
Product prescribing issue	6	13.2 5.9–29.1ROR 13.3 · χ² 56 / p 4e-14	9.5 EB05 3.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0	no trial data cached
Application site pain	6	12.2 5.5–26.9ROR 12.3 · χ² 51 / p 5e-13	8.6 EB05 3.6 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Skin cancer	5	10.4 4.3–24.8ROR 10.5 · χ² 33 / p 4e-9	6.6 EB05 2.7 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.2	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
Device malfunction	78	51.8 42.3–63.5ROR 62.0 · χ² 3,847 / p <1e-300	51.2 EB05 42.3 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 227.8 · ♀ 0% (drug 39%)	no trial data cached
Device dislocation	78	80.3 65.6–98.4ROR 96.1 · χ² 6,033 / p <1e-300	78.7 EB05 65.1 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 91.7 · ♀ 0% (drug 39%)	no trial data cached
Tendon rupture (torn tendon)	9	32.5 17.0–62.0ROR 33.1 · χ² 244 / p 3e-55	30.5 EB05 17.0 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.0	no trial data cached
Therapy partial responder	7	20.7 9.9–43.3ROR 21.0 · χ² 113 / p 1e-26	18.4 EB05 7.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.8	no trial data cached
Application site pain	6	12.2 5.5–26.9ROR 12.3 · χ² 51 / p 5e-13	8.6 EB05 3.6 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Product prescribing issue	6	13.2 5.9–29.1ROR 13.3 · χ² 56 / p 4e-14	9.5 EB05 3.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0	no trial data cached
Skin cancer	5	10.4 4.3–24.8ROR 10.5 · χ² 33 / p 4e-9	6.6 EB05 2.7 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.2	no trial data cached
Drug effective for unapproved indication	4	6.1 2.3–16.2ROR 6.2 · χ² 12 / p 2e-4	3.9 EB05 1.7 · IC025 +0.2	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Application site rash	3	9.7 3.1–30.0ROR 9.8 · χ² 16 / p 4e-5	5.0 EB05 1.8 · IC025 +0.0	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Hepatic cytolysis	3	11.0 3.5–33.8ROR 11.0 · χ² 18 / p 1e-5	5.5 EB05 1.9 · IC025 +0.1	No label text to screen label has no adverse-reaction text	serious PRR 9.6	no trial data cached
Breast pain	3	12.6 4.1–38.8ROR 12.6 · χ² 21 / p 2e-6	6.4 EB05 2.0 · IC025 +0.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3	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 Ciclopirox Olamine?

In FDA FAERS, the most frequently co-reported reaction terms for Ciclopirox Olamine are tendon rupture, application site pain, skin cancer, drug effective for unapproved indication, application site rash, hepatic cytolysis. 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 Ciclopirox Olamine have an FDA boxed warning?

No. The FDA label retrieved for Ciclopirox Olamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ciclopirox Olamine 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 1a74ed86-997a-4b86-b54a-b2b2c94e8abb, effective 20260420; matched on openfda.generic_name.exact:"CICLOPIROX OLAMINE" 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, 11 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.