Clascoterone (Winlevi®)

Topical Androgen Receptor Antagonist
Compare To Other Treatments

The following side effects are expected to occur in the first few weeks of using clascoterone cream. These side effects usually decrease with continued use of clascoterone. Contact your doctor if these symptoms are severe and/or do not go away:

How Common (based on clinical studies)

ErythemaUp to 12.2% of all users
Dryness of skinUp to 10.5% of all users
Burning, stinging, or tingling sensationsUp to 4.2% of all users
SwellingUp to 3.6% of all users
Purplish stretch marksUp to 2.5% of all users
Thining of the skinUp to 1.6% of all users
Telangiectasias or spider veinsUp to 1.2% of all users

Contact your doctor if you experience any of the following side effects:

  • Application site hypersensitivity
  • Changes in oiliness of the skin
  • Facial acute dermatitis
  • Change of hair color on the nose

If you experience any of the following side effects, stop using clascoterone immediately and contact your doctor or get emergency medical care right away:

  • A sudden appearance of swelling and rash (known as hives)
  • Swelling of the eyes, lips, tongue, or entire face
  • Severe itching
  • Trouble breathing or swallowing
  • Changes in voice (hoarseness)

Clascoterone may also cause other side effects that are not mentioned here. Contact your doctor if you experience any other troublesome symptoms when using clascoterone.

  1. DailyMed. National Library of Medicine. WINLEVI-clascosterone cream. [online] Available at: [Accessed 07 Oct.2023].
  2. Mazzetti A, Moro L, Gerloni M, Cartwright M. A Phase 2b, Randomized, Double-Blind Vehicle Controlled, Dose Escalation Study Evaluating Clascoterone 0.1%, 0.5%, and 1% Topical Cream in Subjects With Facial Acne. Journal of Drugs in Dermatology. 18(6), 570 (2019).
  3. Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. Journal of the American Medical Association Dermatology. 156(6), 621-630 (2020).
  4. Eichenfield L, Hebert A, Gold LS, Cartwright M, Fragasso E, Moro L, Mazzetti A. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. Journal of the American Academy of Dermatology. 83(2), 477-485 (2020).
  5. Eichenfield LF, Hebert AA, Gold LS, Cartwright M, Moro L, Han J, Squittieri N, Mazzetti A. Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris. Journal of Drugs in Dermatology. 22(8), 810-816 (2023).