From the FDA Drug Label
Most 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. Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials.
The side effects associated with clascoterone therapy for acne include:
- Local irritation: pruritus, burning, skin redness, or peeling
- Erythema/reddening
- Pruritus
- Scaling/dryness
- Edema
- Stinging
- Burning
- Hypothalamic-pituitary-adrenal (HPA) axis suppression
- Hyperkalemia: elevated potassium levels 1 1 1
From the Research
Clascoterone therapy for acne is generally well-tolerated, but it can cause several side effects, including redness, scaling, dryness, and burning at the application site, as reported in a recent study published in 2023 2. The most common side effects of clascoterone include:
- Redness
- Scaling
- Dryness
- Burning at the application site Some patients may experience skin irritation, itching, or peeling, while less frequently, users might develop contact dermatitis or worsening of acne temporarily. Systemic side effects are rare since clascoterone has minimal absorption into the bloodstream, as noted in a study published in 2021 3. The medication works as a topical androgen receptor inhibitor, blocking the effects of androgens in the skin that contribute to acne formation. It's typically applied as a 1% cream twice daily to affected areas. If irritation becomes severe or persistent, patients should reduce application frequency or temporarily discontinue use, as suggested in a review published in 2024 4. Most local side effects are mild to moderate and tend to resolve with continued use as the skin adjusts to the medication. Those with known hypersensitivity to clascoterone or any components of the formulation should avoid using this treatment, as warned in a study published in 2023 5. Overall, clascoterone is a safe and effective treatment option for patients with acne vulgaris, as confirmed by a recent review published in 2021 6.