Note: This document contains side effect information about clascoterone topical. Some dosage forms listed on this page may not apply to the brand name Winlevi.
Applies to clascoterone topical: topical application cream.
Serious side effects of Winlevi
Along with its needed effects, clascoterone topical (the active ingredient contained in Winlevi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking clascoterone topical:
More common
- Darkening of the skin
- diarrhea
- faintness, especially after missing meals
- irritability
- itching or redness at the application site (severe)
- loss of appetite
- nausea
- raised, dark red, wart-like spots on skin, especially when used on the face
- reddish purple lines on arms, face, legs, trunk, or groin
- unusual tiredness or weakness
- vomiting
Rare
- Dryness, discoloration, pain, or swelling at the application site
- skin rash, hives, itching, or redness
Other side effects of Winlevi
Some side effects of clascoterone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning or stinging at the application site
For Healthcare Professionals
Applies to clascoterone topical: topical cream.
Metabolic
Common: Elevated potassium levels
Frequency not reported: Hyperkalemia[Ref]
Genitourinary
Frequency not reported: Polycystic ovaries, amenorrhea[Ref]
Dermatologic
Very common (10% or more): Erythema/redness (12.2%), scaling/dryness (10.5%)
Common (1% to 10%): Edema, pruritus, skin atrophy, stinging/burning, striae rubrae, telangiectasia[Ref]
Endocrine
Common: Hypothalamic-pituitary-adrenal axis suppression[Ref]
