What the label lists and what reports show
Crotamiton side effects
Crotamiton's FDA label lists its adverse reactions in its own words. FAERS holds 606 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (61 reports).
- Generic listed
Check it at the source: the crotamiton FDA label on DailyMed (effective December 17, 2025, Journey Medical Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsPrimary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
Source: FDA drug label, Journey Medical Corporation, effective December 17, 2025 (SPL set 99c826aa-c7dd-4e60-be9c-e9c151033d13), via openFDA; the full label on DailyMed
What do FAERS reports show?
606 reports list crotamiton among the medicines taken, each a report of something that happened, not proof the medicine caused it; 78 are coded as a death and 257 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 25 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Crotamiton: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions