What the label lists and what reports show
Clascoterone side effects
Clascoterone's FDA label: “Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness.” FAERS holds 1,418 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 product storage error (333 reports).
- No generic listed
Check it at the source: the clascoterone FDA label on DailyMed (effective January 2, 2025, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of WINLEVI cream?WINLEVI cream can cause serious side effects, including: Local skin reactions. WINLEVI cream may cause local skin irritation including itching, burning, skin redness or peeling. Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment with WINLEVI. Your healthcare provider may stop your treatment with WINLEVI if you develop any adrenal problems. The most common side effects of WINLEVI cream include reddening, scaling or dryness, and itching of the skin being treated. These are not all of the possible side effects of WINLEVI cream. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective January 2, 2025 (SPL set 1673a84b-7f5c-47ab-a99c-1e3db21a6a09), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | WINLEVI Cream 1% (N=674 a ) | Vehicle Cream (N=656 a ) |
|---|---|---|
| Edema | 24 (3.6%) | 23 (3.5%) |
| Erythema/redness | 82 (12.2%) | 101 (15.4%) |
| Pruritus | 52 (7.7%) | 54 (8.2%) |
| Scaling/dryness | 71 (10.5%) | 68 (10.4%) |
| Skin atrophy | 11 (1.6%) | 17 (2.6%) |
| Stinging/burning | 28 (4.2%) | 28 (4.3%) |
| Striae rubrae | 17 (2.5%) | 10 (1.5%) |
| Telangiectasia | 8 (1.2%) | 12 (1.8%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied WINLEVI cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years. Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle. …
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective January 2, 2025 (SPL set 1673a84b-7f5c-47ab-a99c-1e3db21a6a09), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,418 reports list clascoterone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 6 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 15 reactions below, 3 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?
- Clascoterone: 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