Patient Medication Information: uses, side effects, how to take - Winlevi
What WINLEVI is used for:
- WINLEVI is used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
How WINLEVI works:
WINLEVI belongs to a group of medicines called androgen receptor inhibitors. The exact way that WINLEVI works is not known. It is thought to treat acne by blocking androgens in your skin from making too much sebum (oils that keep your skin moist).
The ingredients in WINLEVI are:
Medicinal ingredient(s): clascoterone
Non-medicinal ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, DL-alpha tocopherol (vitamin E), mono- and di-glycerides, mineral oil, polysorbate 80, propylene glycol, and water.
WINLEVI comes in the following dosage form(s):
Cream 1%
Do not use WINLEVI if:
- you are allergic to clascoterone or any of its ingredients (see The ingredients in WINLEVI are:)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take WINLEVI. Talk about any health conditions or problems you may have, including if you:
- were previously or are currently taking corticosteroid drugs
- have skin problems, including eczema, cuts or sunburn
are pregnant or plan to become pregnant. It is not known if WINLEVI will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if WINLEVI passes into breast milk. Talk to your healthcare professional about the best way to feed your baby during treatment with WINLEVI.
Other warnings you should know about:
Avoid using skin products that may dry or irritate your skin such as:
- medicated or abrasive soaps and cleansers
- soaps, cleansers, and cosmetics that have strong skin drying effects
- products that contain high amounts of alcohol
- astringents (used to dry or shrink skin tissue), spices, or lime
You may experience adrenal suppression as a rare side effect of taking WINLEVI. This is where the adrenal gland does not make enough of certain hormones. Some people have no symptoms unless they are exposed to stress. If you experience a medical emergency (such as an infection) or have surgery, tell your healthcare professional that you are taking WINLEVI. Adrenal suppression may cause further issues in these cases. See the “Serious side effects and what to do about them” table, below.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to use WINLEVI:
- Use WINLEVI exactly as your healthcare professional tells you to use it.
- Do not give WINLEVI to other people, even if they have the same symptoms you have. It may harm them.
- WINLEVI is to be used on the skin only (topical). Do not use WINLEVI in or on your eyes, mouth, or vagina.
- Do not apply WINLEVI on areas with cuts, scratches, rashes or sunburns.
- Avoid getting WINLEVI into your eyes, lips, mouth, corners of the nose, or mucous membranes. If contact with mucous membranes happens, rinse immediately and thoroughly with water.
- Before applying WINLEVI, gently wash and dry the entire area of the skin to be treated.
- Do not spot treat for best results.
- Wash your hands after applying WINLEVI.
Usual dose:
Apply a thin even layer of WINLEVI over the area prone to acne, twice a day, in the morning and in the evening. The recommended dose per application of WINLEVI is up to 1 gram (approximately the length of 2 fingertips). When spread on the skin, this should be enough to cover the size of two adult palms or one adult face.
Overdose:
If you think you, or a person you are caring for, have taken too much WINLEVI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you forget to apply a dose, the next dose should be applied at the usual time. Apply the same amount you usually would. Do not apply extra.
Possible side effects from using WINLEVI:
These are not all the possible side effects you may have when taking WINLEVI. If you experience any side effects not listed here, tell your healthcare professional.
- Local skin irritation such as itching, burning, skin redness, peeling, scaling, dryness or change of hair colour at the area of application.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Rare | |||
| Adrenal effects (may include one or several): Unexplained fatigue, weakness, nausea, stomach pain, or joint / muscle pain | √ | ||
Adrenal effects (may include one or several): Unexplained weight loss, absence of menstruation, vomiting, impaired memory, depression, or altered mental state (psychosis). Talk to your healthcare professional if these symptoms appear, but you’re not sure why. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Pharmacist: Before dispensing store the product in a refrigerator between 2°C and 8°C. Do not freeze.
At home: Store at room temperature (20°C to 25°C). Do not freeze. Discard the unused product 6 months after the date of dispensing or 6 months after first opening, whichever is sooner.
Keep out of the reach and sight of children.
If you want more information about WINLEVI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sunpharma.com/canada; or by calling 1-844-924-0656.
Imported and distributed by Sun Pharma Canada Inc., Brampton, ON L6T 1C1.
Last Revised: 2026-06-30
WINLEVI is a registered trademark of Cassiopea, S.p.A., used under exclusive license.
© 2026 Sun Pharma, or its subsidiaries and affiliates. All rights reserved.