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The following safety information outlines essential precautions and potential risks associated with the use of Winlevi (clascoterone). It is crucial to understand these warnings and discuss any concerns with your healthcare provider.

• Skin Reactions: Winlevi (clascoterone) may lead to skin irritation, including redness, itching, peeling, and dryness. The likelihood of these reactions increases if you use other irritating products, such as medicated soaps or those containing drying agents like alcohol. Avoid applying Winlevi (clascoterone) to already irritated skin, such as areas with cuts, wounds, or burns. If skin irritation persists or worsens, contact your healthcare provider promptly, as a medication change might be necessary. Individuals with a history of skin reactions, sensitive skin, or those using other irritating skin products are at a heightened risk.

• Low Hormone Levels: This medication can cause adrenal suppression, affecting your body's hormone production. Children and adolescents are particularly vulnerable to this side effect. Be alert for signs of adrenal suppression, such as extreme fatigue, muscle weakness, and decreased appetite, and inform your dermatologist immediately if they occur. You may need to discontinue use until hormone levels stabilize, typically within a month. Risks increase with prolonged use, application over large body areas, or when skin is covered with bandages post-application, particularly in children or adolescents.

There are no known contraindications for Winlevi (clascoterone). Always consult your healthcare provider before starting or making changes to your medication regimen.

When using this medication, some individuals may experience mild side effects such as redness, peeling, dryness, or itching of the skin. These effects are generally not serious and tend to improve over time. However, if they persist or worsen, it is advisable to consult your healthcare provider for guidance.

In addition to these common side effects, some users have reported experiencing stinging, burning, swelling, stretch marks, spider veins, or thinning of the skin. There may also be a disruption in menstrual cycles. If you experience any of these effects, particularly if they are severe, contacting your healthcare provider for advice is recommended.

Rare but serious side effects can occur and require immediate medical attention. These include symptoms of an allergic reaction such as rash, itching, hives, or swelling of the face, lips, tongue, or throat. Other serious concerns include burning, crusting, peeling of treated skin, and signs of low adrenal gland function like nausea, vomiting, loss of appetite, unusual fatigue, or dizziness. If any of these symptoms appear, seek urgent medical care. It is important to monitor your condition and communicate with your healthcare provider about any unusual changes.