Winlevi (Clascoterone) – Side Effects, Interactions, Uses, Dosage, Warnings

Clascoterone topical is used to treat acne vulgaris in people who are at least 12 years old.

Clascoterone topical may also be used for purposes not listed in this medication guide.


What is Winlevi (Clascoterone) used for?

  • Acne


What is the most important information I should know about Winlevi (Clascoterone)?

Tell your doctor if you have ever had eczema or other skin problems.

Tell your doctor if you are pregnant or breastfeeding.

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Side Effects

What are the side effects of Winlevi (Clascoterone)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe itching, burning, peeling, or redness of treated skin;
  • high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
  • decreased adrenal gland hormones–nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious side effects may be more likely to occur in younger people.

Common side effects may include:

  • redness, itching, stinging, burning, or swelling of treated skin; or
  • dry or scaly skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Winlevi (Clascoterone) if I’m pregnant or breastfeeding?

Tell your doctor if you are pregnant or breastfeeding.


What drugs and food should I avoid while taking Winlevi (Clascoterone)?

Avoid applying this medicine to open wounds, areas of eczema, or on sunburned or irritated skin.

Avoid getting this medicine in your eyes, mouth, nose, vagina, or rectum. Rinse with water if this occurs.

Avoid using harsh soaps, scrubbing cleansers, or any cosmetics or other skin products that can cause dryness or irritation. Avoid using skin products that contain alcohol, astringents, or lime.

Dosage Guidelines & Tips

How to take Winlevi (Clascoterone)?

Use Winlevi (Clascoterone) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Wash your hands before and after applying this medicine. Use a mild soap to clean the skin area to be treated.

Dry the skin thoroughly before applying clascoterone topical.

Use only a small amount of medicine. Apply a thin layer and rub in gently.

Clascoterone topical is usually applied twice per day, morning and evening. Follow your doctor's dosing instructions very carefully.

Do not cover treated skin with a bandage unless your doctor tells you to.

Store tightly closed at room temperature away from moisture and heat. Do not freeze.

Throw away any unused clascoterone cream 1 month after you first opened the tube or 180 days after you received this medicine from the pharmacy (whichever comes first).

What should I do if I missed a dose of Winlevi (Clascoterone)?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Overdose Signs

What happens if I overdose on Winlevi (Clascoterone)?

If you think you or someone else may have overdosed on: Winlevi (Clascoterone),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn't breathing after taking Winlevi (Clascoterone), call 911


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