Can Winlevi Cause Headaches? Understanding the Potential Side Effects

October 9, 2025 •

4 min read

In clinical trials for Winlevi (clascoterone) cream, adverse effects were generally similar between the treatment and vehicle (placebo) groups, suggesting a relatively mild safety profile. However, some users have reported headaches as a potential side effect, raising the important question: Can Winlevi cause headaches?.

Quick Summary

An examination of Winlevi's side effect profile shows that while the drug is generally well-tolerated, headaches have been reported in some clinical study participants. Most common side effects are localized skin reactions. Systemic absorption is minimal, which is a key factor in its overall safety.

Key Points

Headaches are a reported but rare side effect of Winlevi: Clinical trials indicate that the incidence of headaches among Winlevi users is often similar to that of a placebo, suggesting a low frequency.
Winlevi's mechanism is highly localized: As a topical androgen receptor inhibitor, Winlevi's clascoterone is quickly metabolized in the skin, limiting systemic absorption and reducing the likelihood of widespread side effects like severe headaches.
Compare risk with oral acne medications: The risk of headaches with Winlevi is significantly lower compared to systemic treatments like oral isotretinoin or tetracycline antibiotics, which carry a rare but serious risk of drug-induced intracranial hypertension.
Seek medical advice for persistent or severe headaches: While mild headaches may resolve on their own, a healthcare provider should be consulted if they are severe, persistent, or accompanied by other symptoms like vision changes.
Proper application minimizes systemic risk: To reduce any potential for systemic effects, Winlevi should be applied as directed, avoiding use over large surface areas or with occlusive dressings.

Can Winlevi cause headaches? Breaking down the evidence

Winlevi (clascoterone) cream is a topical androgen receptor inhibitor used to treat acne vulgaris in patients 12 years and older. As with any medication, it is important to understand its potential side effects. While the most frequently reported side effects are localized to the application area, headaches are listed among the potential adverse reactions. The mechanism and frequency of these headaches, however, requires a closer look at the available data.

Analyzing the side effect data

According to data from clinical trials, headaches were among the adverse reactions reported by some participants using clascoterone. It's crucial to understand that during clinical trials, these effects are compared against a vehicle (placebo) cream. In the studies cited by DermNet, the frequency of adverse effects with clascoterone was similar to that of the vehicle cream, suggesting a low incidence that might not be directly attributable to the medication alone. Drugs.com also notes that while severe headaches are listed among potential serious side effects, they are much less common than localized skin reactions.

How Winlevi's mechanism influences its side effect profile

Winlevi's mechanism of action is highly localized and a key reason why it has a low incidence of systemic side effects. The active ingredient, clascoterone, is a first-in-class topical androgen receptor inhibitor. Instead of impacting the body systemically like some oral acne medications, it works by competing with dihydrotestosterone (DHT) for binding to androgen receptors within the skin's sebaceous glands.

This binding action helps to reduce sebum (oil) production and inflammation at the source. Once applied, clascoterone is rapidly metabolized into an inactive compound called cortexolone by enzymes present in the skin, limiting its systemic absorption. This minimized systemic exposure is what typically makes Winlevi safer from widespread side effects, unlike oral alternatives that can trigger more severe and systemic reactions.

How does this compare to other acne treatments?

To put the risk of headaches from Winlevi into context, it helps to compare it with other, more systemically-absorbed acne medications. For instance, oral isotretinoin (formerly brand name Accutane) is well-known for its potential to cause a variety of systemic side effects, including headaches and, in rare but serious cases, increased intracranial pressure. Oral tetracycline-class antibiotics, such as doxycycline and minocycline, also carry a similar, though rare, risk of drug-induced intracranial hypertension, with persistent headaches being a key symptom.

Comparison of common acne medication side effects


Feature	Winlevi (Topical Clascoterone)	Oral Isotretinoin	Oral Tetracycline Antibiotics
Mechanism	Topical androgen receptor inhibitor with minimal systemic absorption.	Oral vitamin A derivative with systemic effects.	Oral antibiotics with systemic anti-inflammatory effects.
Incidence of Headache	Rare; reported in clinical trials, but often comparable to placebo.	Common; more frequent than with Winlevi.	Possible, and a symptom of rare but serious intracranial hypertension.
Other Common Side Effects	Localized skin irritation (redness, dryness, itching), scaling.	Dry skin, dry lips, joint pain, sun sensitivity.	Sun sensitivity, stomach upset, dizziness.
Risk of Serious Systemic Side Effects	Low; minimal absorption limits widespread effects. Some risk of HPA axis suppression with prolonged use over large areas.	Higher; includes risk of increased intracranial pressure, organ damage, depression.	Potential for increased intracranial pressure and other systemic issues.

How to manage potential headaches while on Winlevi

If a patient experiences headaches while using Winlevi, it's important to differentiate it from other causes. It's possible the headache is unrelated to the medication and could be triggered by other factors like dehydration or stress. However, if headaches persist or are severe, it's crucial to consult a healthcare provider. Some strategies for managing medication-related headaches include:

Rest and Hydration: Ensure you are getting enough rest and staying well-hydrated, as dehydration can exacerbate headaches.
Over-the-counter pain relievers: For mild headaches, over-the-counter pain relievers like ibuprofen or acetaminophen may provide relief. Always check with a pharmacist or doctor to ensure there are no contraindications.
Consult a doctor: If the headaches are severe, persistent, or accompanied by other symptoms like vision changes, seek immediate medical attention. A doctor can rule out more serious issues and determine if Winlevi is the cause.

Conclusion

Based on clinical trial data and Winlevi's highly localized mechanism of action, headaches appear to be a rare side effect, often reported with a frequency similar to that of a placebo cream. This is in stark contrast to oral medications like isotretinoin or tetracyclines, where systemic absorption can lead to a higher risk of headaches and more serious complications. While generally well-tolerated, any persistent or severe headaches should be discussed with a healthcare provider to ensure proper care and rule out other underlying conditions. Winlevi remains a valuable topical option for acne, offering a strong safety profile due to its localized action.

Frequently Asked Questions

No, headaches are not a common side effect of Winlevi. Clinical trial data indicates that headaches were reported with a frequency similar to that of the placebo cream, suggesting that the occurrence is likely rare and often not directly caused by the medication itself.

The risk is low because Winlevi works locally on the skin and has minimal systemic absorption. The active ingredient, clascoterone, is rapidly converted into an inactive compound within the skin, preventing it from having widespread effects on the body.

If you experience a mild headache, staying hydrated and resting can help. Over-the-counter pain relievers can also be used, but you should consult a doctor if the headache is persistent, severe, or accompanied by other symptoms like vision changes.

Severe headaches have been listed among the serious potential adverse effects, but are considered very rare. If you experience a severe headache along with symptoms like vision changes, confusion, or weakness, seek immediate medical attention.

While Winlevi's minimal systemic absorption limits drug interactions, it's always wise to inform your doctor about all medications you are taking, especially if you are prone to headaches or taking other drugs known to cause them.

No specific type of headache is uniquely associated with Winlevi, primarily because its systemic absorption is so low. In rare cases of systemic effects from some acne medications, headaches can be a symptom of increased intracranial pressure, but this is a much more significant risk with oral medications.

Yes, headaches can be caused by many factors including stress, dehydration, or other medications. Given the low incidence of headaches directly linked to Winlevi in clinical studies, it's very possible your headaches have an unrelated cause.