Crotamiton side effects: what 606 FDA adverse event reports show

Crotamiton · Pruradik · 12 reaction terms · 111 drug–reaction co-reports · data 2026-09-14

Drug class

Scabicidal and antipruritic agent as a lotion

FDA label, Indications wording

Brand names

Pruradik

openFDA label

Who reports

606 reports · 95% serious · 78 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pruradik ™ (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203. 28.

FDA label, Indications and Usage

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 9 strongest signals

No label text to screen 9

What the badges mean

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. 3 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
Hepatomegaly	12	41.8 23.8–73.1ROR 42.6 · χ² 437 / p 2e-97	39.3 EB05 24.0 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.8	no trial data cached
Erythema multiforme	11	40.5 22.6–72.8ROR 41.3 · χ² 385 / p 4e-86	38.0 EB05 22.7 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.3	no trial data cached
Hepatic function abnormal	25	23.2 15.8–34.0ROR 24.1 · χ² 509 / p 6e-113	22.8 EB05 16.2 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.3 · 96% clinician	no trial data cached
Affect lability	5	17.8 7.4–42.5ROR 17.9 · χ² 63 / p 9e-16	13.3 EB05 4.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.2	no trial data cached
Drug eruption	9	17.5 9.2–33.5ROR 17.8 · χ² 124 / p 4e-29	15.8 EB05 7.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.0	no trial data cached
Mass	7	17.1 8.2–35.8ROR 17.3 · χ² 91 / p 7e-22	14.5 EB05 5.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.2	no trial data cached
Dermatitis allergic	6	16.5 7.5–36.6ROR 16.7 · χ² 73 / p 8e-18	13.1 EB05 4.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	no trial data cached
Skin burning sensation	15	7.2 4.4–11.9ROR 7.4 · χ² 75 / p 3e-18	6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.0	no trial data cached
Skin irritation	9	6.7 3.5–12.9ROR 6.8 · χ² 38 / p 3e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8	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
Hepatic function abnormal	25	23.2 15.8–34.0ROR 24.1 · χ² 509 / p 6e-113	22.8 EB05 16.2 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.3 · 96% clinician	no trial data cached
Skin burning sensation	15	7.2 4.4–11.9ROR 7.4 · χ² 75 / p 3e-18	6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.0	no trial data cached
Hepatomegaly	12	41.8 23.8–73.1ROR 42.6 · χ² 437 / p 2e-97	39.3 EB05 24.0 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.8	no trial data cached
Erythema multiforme	11	40.5 22.6–72.8ROR 41.3 · χ² 385 / p 4e-86	38.0 EB05 22.7 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.3	no trial data cached
Skin irritation	9	6.7 3.5–12.9ROR 6.8 · χ² 38 / p 3e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8	no trial data cached
Drug eruption	9	17.5 9.2–33.5ROR 17.8 · χ² 124 / p 4e-29	15.8 EB05 7.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.0	no trial data cached
Mass	7	17.1 8.2–35.8ROR 17.3 · χ² 91 / p 7e-22	14.5 EB05 5.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.2	no trial data cached
Dermatitis allergic	6	16.5 7.5–36.6ROR 16.7 · χ² 73 / p 8e-18	13.1 EB05 4.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	no trial data cached
Affect lability	5	17.8 7.4–42.5ROR 17.9 · χ² 63 / p 9e-16	13.3 EB05 4.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.2	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	4	5.9 2.2–15.6ROR 5.9 · χ² 12 / p 3e-4	3.8 EB05 1.7 · IC025 +0.2	No label text to screen label has no adverse-reaction text	serious PRR 4.8	no trial data cached
Sudden death	4	12.8 4.8–34.1ROR 12.9 · χ² 33 / p 6e-9	7.6 EB05 2.6 · IC025 +0.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 7.9	no trial data cached
Hepatic encephalopathy	4	14.7 5.5–39.1ROR 14.8 · χ² 38 / p 3e-10	9.1 EB05 2.9 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.1	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 Crotamiton?

In FDA FAERS, the most frequently co-reported reaction terms for Crotamiton are hepatic function abnormal, skin burning sensation, hepatomegaly, erythema multiforme, skin irritation, drug eruption. 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 Crotamiton have an FDA boxed warning?

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

Do FAERS signals prove that Crotamiton 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 3699175f-bfc8-a047-e063-6394a90a80d1, effective 20250602; matched on openfda.generic_name.exact:"CROTAMITON" 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, 12 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.