OpenClaim

Clascoterone Side Effects

The most commonly reported side effects of clascoterone include product storage error, product physical consistency issue, and product use complaint, based on 1,408 FDA adverse event reports from 2020 to 2025. 10.2% of reports found the drug to be ineffective.

Clascoterone side effects

Percentages show how often each reaction appears relative to total reports for clascoterone.

1
Product Storage Error23.7%333
2
Product Physical Consistency Issue23.4%329
3
Product Use Complaint20.3%286
4
Product Dose Omission Issue13.0%183
5
Product Use Issue10.8%152
6
Drug Ineffective10.2%144
7
Therapy Cessation6.1%86
8
Poor Quality Product Administered6.0%84
9
Product Physical Issue5.5%78
10
Condition Aggravated5.3%75
11
Product Quality Issue4.8%67
12
Acne3.3%46
13
Off Label Use2.7%38
14
Erythema2.1%29
15
Liquid Product Physical Issue1.8%25

These are voluntary reports and do not establish that clascoterone caused these reactions.

Report severity

4.9%Serious69 reports
0.4%Hospitalizations6 reports
0.0%Fatal0 reports

Seriousness is determined by the reporter, not by OpenClaim.

Clascoterone drug interactions

Other drugs that appear in adverse event reports alongside clascoterone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab1.1%15
2
Spironolactone1.0%14
3
Isotretinoin0.7%10
4
Sodium-oxybate0.7%10
5
Tazarotene0.4%6
6
Calcium-oxybate0.4%6
7
Magnesium-oxybate0.4%6
8
Potassium-oxybate0.4%6
9
Benzoyl-peroxide0.2%3
10
Arformoterol-tartrate0.2%3
11
Sarecycline-hydrochloride0.2%3
12
Levonorgestrel0.1%2
13
Tretinoin0.1%2
14
Certolizumab-pegol0.1%2
15
Dapsone0.1%2

Taken alongside

1
Tretinoin3.2%45
2
Spironolactone1.3%18
3
Ergocalciferol0.9%13
4
Sertraline-hydrochloride0.9%13
5
Fluticasone0.9%12
6
Cetirizine-hydrochloride0.8%11
7
Levothyroxine-sodium0.7%10
8
Montelukast-sodium0.7%10
9
Clindamycin0.7%10
10
Lamotrigine0.7%10
11
Benzoyl-peroxide0.7%10
12
Magnesium-acetate-tetrahydrate0.6%9
13
Folic-acid0.6%9
14
Levonorgestrel0.6%9
15
Doxycycline0.6%8

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports clascoterone side effects

61.9% of clascoterone adverse event reports involve female patients and 6.7% involve male patients. The largest age group is adult at 79%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.9%
Male6.7%
Unknown31.3%

Age group

< 20.0%
2–110.9%
12–1718.1%
18–6479.5%
65+1.6%

What is clascoterone used for

Conditions and purposes for which patients were taking clascoterone when the adverse event was reported.

Anticoagulant TherapyAcneAcne CysticAcne TropicaAlopeciaAsteatosisBone LossHidradenitisHormone TherapyMenopausal SymptomsOil AcneProduct Used For Unknown IndicationRashRosaceaSebaceous Glands Overactivity

Showing 15 of 17 indications

Clascoterone brand names and reporting trend

Clascoterone is sold under the brand name Winlevi.

Brand names

Winlevi15

Quarterly reports (20202025)

2020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking clascoterone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.