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Winlevi Side Effects

Generic name: clascoterone topical

Medically reviewed by Drugs.com. Last updated on Aug 25, 2022.

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]

References

1. "Product Information. Winlevi (clascoterone topical)." Sun Pharmaceutical Industries (2021):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.