Drug · FAERS side-effect profile with label screen
Ciclopirox side effects: what 2,498 FDA adverse event reports show
Drug class
Protein Synthesis Inhibitors
FDA label (mechanism-of-action class)
Who reports
2,498 reports · 50% serious · 96 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox topical solution, 8% (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum .
FDA label, Indications and Usage
What it is
DESCRIPTION Ciclopirox topical solution, 8% (nail lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.
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
Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 7Lab value / disease marker 1Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 91 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 |
|---|---|---|---|---|---|---|
| Economic problem | 24 | 13.1 8.8–19.5ROR 13.2 · χ² 256 / p 8e-58 | 12.5 EB05 8.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.3 · ♀ 12% (drug 57%) | no trial data cached |
| Anhedonia | 38 | 12.0 8.8–16.5ROR 12.2 · χ² 374 / p 1e-83 | 11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · ♀ 14% (drug 57%) | no trial data cached |
| End stage renal disease | 23 | 10.5 7.0–15.8ROR 10.6 · χ² 188 / p 5e-43 | 9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 27% (drug 57%) | no trial data cached |
| Sinus bradycardia | 11 | 9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Chronic kidney disease | 87 | 9.5 7.8–11.7ROR 9.8 · χ² 657 / p 3e-145 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 33% (drug 57%) | no trial data cached |
| Impaired quality of life | 16 | 9.3 5.7–15.2ROR 9.4 · χ² 111 / p 3e-26 | 8.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Sleep disorder due to a general medical condition | 17 | 8.8 5.5–14.2ROR 8.9 · χ² 110 / p 4e-26 | 7.6 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Cytokine release syndrome | 18 | 7.9 5.0–12.6ROR 8.0 · χ² 102 / p 3e-24 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Osteopenia | 14 | 7.7 4.6–13.0ROR 7.7 · χ² 75 / p 2e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Device dislocation | 37 | 7.2 5.2–9.9ROR 7.2 · χ² 190 / p 2e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 6% (drug 57%) | no trial data cached |
| Dermatitis atopic | 42 | 7.1 5.2–9.5ROR 7.2 · χ² 213 / p 2e-48 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Application site pain | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 9e-16 | 5.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Hepatic cirrhosis | 13 | 5.8 3.4–10.0ROR 5.9 · χ² 47 / p 3e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Fungal infection | 23 | 5.8 3.9–8.7ROR 5.8 · χ² 87 / p 7e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 90% (drug 57%) | no trial data cached |
| Osteoarthritis | 29 | 5.7 4.0–8.2ROR 5.8 · χ² 109 / p 9e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 79% (drug 57%) | no trial data cached |
| Hepatotoxicity (liver damage) | 15 | 5.7 3.4–9.4ROR 5.7 · χ² 53 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Skin fissures | 12 | 5.3 3.0–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Foot fracture | 12 | 5.3 3.0–9.3ROR 5.3 · χ² 38 / p 4e-10 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Device malfunction | 42 | 5.2 3.9–7.1ROR 5.3 · χ² 140 / p 1e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 29.5 · ♀ 16% (drug 57%) | no trial data cached |
| Localised infection | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 47 / p 4e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Dermatitis | 12 | 4.9 2.8–8.5ROR 4.9 · χ² 33 / p 5e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.8 | no trial data cached |
| Psoriatic arthropathy | 23 | 4.8 3.2–7.2ROR 4.8 · χ² 66 / p 3e-16 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 57%) | no trial data cached |
| Bone density decreased | 18 | 4.8 3.0–7.6ROR 4.8 · χ² 50 / p 8e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Ischaemic stroke | 10 | 4.7 2.5–8.7ROR 4.7 · χ² 26 / p 2e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Pain of skin | 15 | 4.7 2.8–7.7ROR 4.7 · χ² 40 / p 2e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Skin lesion | 15 | 4.6 2.8–7.7ROR 4.6 · χ² 39 / p 2e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Incorrect product administration duration | 11 | 4.5 2.5–8.2ROR 4.6 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Eczema | 27 | 4.5 3.1–6.6ROR 4.5 · χ² 70 / p 3e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 79% (drug 57%) | no trial data cached |
| Product dose omission in error | 14 | 4.4 2.6–7.4ROR 4.4 · χ² 33 / p 4e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Drug resistance | 13 | 4.2 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Psoriasis | 66 | 4.2 3.3–5.4ROR 4.3 · χ² 161 / p 4e-37 | 4.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Pollakiuria (frequent urination) | 21 | 4.2 2.8–6.5ROR 4.3 · χ² 49 / p 1e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Eye pain | 26 | 4.0 2.7–5.8ROR 4.0 · χ² 54 / p 8e-14 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Movement disorder | 15 | 3.9 2.4–6.5ROR 3.9 · χ² 30 / p 3e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Application site erythema | 12 | 3.8 2.2–6.7ROR 3.8 · χ² 22 / p 1e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Emotional distress | 55 | 3.8 2.9–4.9ROR 3.9 · χ² 111 / p 3e-26 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 26% (drug 57%) | no trial data cached |
| Limb injury | 12 | 3.7 2.1–6.5ROR 3.7 · χ² 21 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Skin exfoliation | 36 | 3.6 2.6–5.0ROR 3.7 · χ² 66 / p 2e-16 | 3.5 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 79% (drug 57%) | no trial data cached |
| Drug ineffective for unapproved indication | 23 | 3.5 2.3–5.2ROR 3.5 · χ² 38 / p 4e-10 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · 83% consumer | no trial data cached |
| Rash pruritic | 22 | 3.4 2.3–5.2ROR 3.4 · χ² 35 / p 1e-9 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | 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 | 87 | 9.5 7.8–11.7ROR 9.8 · χ² 657 / p 3e-145 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 33% (drug 57%) | no trial data cached |
| Psoriasis | 66 | 4.2 3.3–5.4ROR 4.3 · χ² 161 / p 4e-37 | 4.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Emotional distress | 55 | 3.8 2.9–4.9ROR 3.9 · χ² 111 / p 3e-26 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 26% (drug 57%) | no trial data cached |
| Wrong technique in product usage process | 46 | 1.9 1.4–2.5ROR 1.9 · χ² 19 / p 6e-6 | 1.9 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.6 · 91% consumer | no trial data cached |
| Dry skin | 46 | 2.9 2.2–3.9ROR 3.0 · χ² 57 / p 2e-14 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Device malfunction | 42 | 5.2 3.9–7.1ROR 5.3 · χ² 140 / p 1e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 29.5 · ♀ 16% (drug 57%) | no trial data cached |
| Dermatitis atopic | 42 | 7.1 5.2–9.5ROR 7.2 · χ² 213 / p 2e-48 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Anhedonia | 38 | 12.0 8.8–16.5ROR 12.2 · χ² 374 / p 1e-83 | 11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · ♀ 14% (drug 57%) | no trial data cached |
| Device dislocation | 37 | 7.2 5.2–9.9ROR 7.2 · χ² 190 / p 2e-43 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 6% (drug 57%) | no trial data cached |
| Skin exfoliation | 36 | 3.6 2.6–5.0ROR 3.7 · χ² 66 / p 2e-16 | 3.5 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 79% (drug 57%) | no trial data cached |
| Product quality issue | 35 | 2.2 1.6–3.0ROR 2.2 · χ² 21 / p 2e-6 | 2.1 EB05 1.6 · IC025 +0.5 | Reporting / coding artifact | serious PRR 0.9 · 91% consumer | no trial data cached |
| Osteoarthritis | 29 | 5.7 4.0–8.2ROR 5.8 · χ² 109 / p 9e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 79% (drug 57%) | no trial data cached |
| Eczema | 27 | 4.5 3.1–6.6ROR 4.5 · χ² 70 / p 3e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 79% (drug 57%) | no trial data cached |
| Eye pain | 26 | 4.0 2.7–5.8ROR 4.0 · χ² 54 / p 8e-14 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Economic problem | 24 | 13.1 8.8–19.5ROR 13.2 · χ² 256 / p 8e-58 | 12.5 EB05 8.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.3 · ♀ 12% (drug 57%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anhedonia — n=38, PRR 12.0
- End stage renal disease — n=23, PRR 10.5
- Chronic kidney disease — n=87, PRR 9.5
- Dermatitis atopic — n=42, PRR 7.1
- Fungal infection — n=23, PRR 5.8
- Osteoarthritis — n=29, PRR 5.7
- Psoriatic arthropathy — n=23, PRR 4.8
- Eczema — n=27, PRR 4.5
- Psoriasis — n=66, PRR 4.2
- Pollakiuria — n=21, PRR 4.2
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?
In FDA FAERS, the most frequently co-reported reaction terms for Ciclopirox are chronic kidney disease, psoriasis, emotional distress, dry skin, dermatitis atopic, anhedonia. 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 have an FDA boxed warning?
No. The FDA label retrieved for Ciclopirox has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ciclopirox 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 1548af93-0dc1-4606-865f-6201b2bb7de1, effective 20251022; matched on
openfda.generic_name.exact:"CICLOPIROX") - 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, 131 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.