Winlevi Side Effects (Guide)

Teenage Boy Struggling with Acne and Skin Irritation from Medication

Winlevi is a topical cream containing 1% clascoterone, a drug used to treat acne vulgaris in patients aged 12 and older. It works by targeting and blocking androgen receptors in the skin, which helps reduce the production of sebum (skin oil) that contributes to acne development. Clascoterone belongs to the class of antiandrogens, and its mechanism of action is similar to that of oral antiandrogens like spironolactone, but it is applied locally, minimizing systemic effects. Winlevi is a prescription medication and is not available over-the-counter. It is typically prescribed for moderate to severe acne and has been shown to be effective in reducing both inflammatory and non-inflammatory lesions when used as directed.

Key Takeaways

Winlevi is a topical cream containing 1% clascoterone, used to treat moderate to severe acne by blocking androgen receptors in the skin to reduce sebum production.
Common side effects include mild irritation at the application site, such as itching, redness, burning, and peeling, affecting 7% to 12% of patients.
Long-term use may lead to rare, laboratory-detected effects such as hypothalamic-pituitary-adrenal axis suppression and hyperkalemia, but these do not typically result in significant clinical symptoms or adverse effects.

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Winlevi Side Effects

Based on the FDA label for Winlevi (clascoterone), the most common side effects reported in clinical trials include:

Application Site Reactions:
- Incidence: These reactions were reported in about 7% of patients. They include irritation, redness, or dryness at the site of application. These are typically mild to moderate and tend to resolve after discontinuation or reduction in the frequency of use.
Skin Irritation:
- Incidence: Skin irritation was observed in about 3% of patients. This may manifest as a burning or stinging sensation upon application, which is usually transient.
Dry Skin:
- Incidence: About 2% of patients experience dry skin as a side effect, which is commonly associated with topical treatments.
Headache:
- Incidence: Headache was reported in approximately 1% of patients, though this side effect is less common.
Fatigue:
- Incidence: Fatigue also occurred in 1% of patients.

These side effects are generally mild and tend to diminish with continued use or adjustments to application frequency. However, patients are advised to monitor for any adverse reactions, and if severe irritation or other signs of an allergic reaction occur, they should discontinue use and consult a healthcare provider.

For a more detailed breakdown, always refer to the full FDA label for the most accurate and specific data.

Winlevi Side Effects Compared to Similar Medications

Here’s a comparison of common side effects between Winlevi (clascoterone) and other similar acne treatments:

Medication	Common Side Effects	Frequency of Side Effects	Other Notes
Winlevi (Clascoterone)	Skin irritation (itching, redness, burning, peeling)	7% to 12% of patients	Generally mild; no significant discontinuations due to side effects.
Benzoyl Peroxide	Dryness, redness, peeling, irritation	Common (varies by individual)	Can cause more severe dryness compared to clascoterone.
Topical Retinoids (e.g., Tretinoin)	Skin irritation, dryness, peeling, redness	Very common (50% to 80% in some studies)	Often requires gradual introduction to minimize irritation.
Salicylic Acid	Skin dryness, peeling, irritation	Common (especially at higher concentrations)	Less irritating than retinoids, but still causes dryness.
Oral Spironolactone	Hyperkalemia, menstrual irregularities, fatigue, dizziness	Rare, but significant (affects <1% of patients)	Used off-label for acne, can cause systemic hormonal effects.

Winlevi General Safety

Clascoterone, the active ingredient in Winlevi, is generally considered safe with a low frequency of adverse effects, particularly in patients with moderate to severe acne. In clinical studies involving 722 patients, the safety profile of clascoterone was similar to that of a vehicle cream, with most adverse effects being mild and localized to the application site, such as itching, redness, burning, and peeling (7-12% of patients). These effects typically did not lead to significant treatment discontinuation.

Clascoterone’s systemic exposure is low due to its topical use, but, given its structural similarities to the oral antiandrogen spironolactone, it may pose potential risks like hyperkalemia and hormonal disturbances, though these side effects have been rare and clinically insignificant. Laboratory-detected suppression of the hypothalamic-pituitary-adrenal (HPA) axis and mild hyperkalemia were observed in a few patients without any significant clinical impact.

While clascoterone is not recommended for children under 12 and there is limited data on its use during pregnancy, more research is needed to understand the potential risks, including effects on birth defects or pregnancy outcomes. Nonetheless, it is well tolerated in most patients with acne, showing favorable effectiveness in reducing inflammatory and non-inflammatory lesions after 12 weeks of treatment.

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Sources

U.S. Food and Drug Administration. Center for Drug Evaluation and Research. NDA/BLA multidisciplinary review and evaluation: NDA 213433. Winlevi (clascoterone) cream, 1%. Accessed March 16, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf.
U.S. Food and Drug Administration. Drug label information. Winlevi (clascoterone) cream. Accessed March 1, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf.
Hebert A, Thiboutot D, Stein Gold L, et al. "Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials." JAMA Dermatology. 2020;156(6):621-630.
Eichenfield L, Hebert A, Stein Gold L, et al. "Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris." J Am Acad Dermatol. 2020;83(2):477-485.
Brown J, Farquhar C, Lee O, et al. "Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne." Cochrane Database Syst Rev. 2009;(2):CD000194.