Mentax Side Effects

Please note - some side effects for Mentax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mentax - for the Consumer

Mentax Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mentax Cream:

Burning; inflammation; irritation; itching; redness; stinging.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Mentax Side Effects - for the Professional

Mentax

In controlled clinical trials, 9 (approximately 1%) of 815 patients treated with Mentax® Cream, 1%, reported adverse events related to the skin. These included burning/stinging, itching and worsening of the condition. No patient treated with Mentax® Cream, 1%, discontinued treatment due to an adverse event. In the vehicle-treated patients, 2 of 718 patients discontinued because of treatment site adverse events, one of which was severe burning/stinging and itching at the site of application.

In uncontrolled clinical trials, the most frequently reported adverse events in patients treated with Mentax® Cream, 1%, were: contact dermatitis, erythema, irritation, and itching, each occurring in less than 2% of patients.

In provocative testing in over 200 subjects, there was no evidence of allergic-contact sensitization for either cream or vehicle base for Mentax® Cream, 1%.

Side Effects by Body System

General

Topical butenafine is generally well tolerated. Adverse effects are related to the site of application. In controlled clinical trials no patients withdrew from treatment due to adverse effects.

Dermatologic

Dermatologic side effects have included burning, stinging, worsening of the condition, contact dermatitis, erythema, irritation, and itching in less than 2% of patients.

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