Azelex Side Effects

Please note - some side effects for Azelex 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 Azelex - for the Consumer

Azelex 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 Azelex Cream:

Dryness; temporary burning, itching, redness, stinging, or tingling at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in skin color; peeling, irritation, or inflammation of skin.

Azelex Side Effects - for the Professional

Azelex

During U.S. clinical trials with Azelex®Cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of Azelex®Cream.

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

Side Effects by Body System

Local

Local irritation occurs during the first few weeks of treatment and generally presents as pruritus, scaling, burning and tingling.

Respiratory

Respiratory side effects have included worsening of asthma in rare instances.

Dermatologic

Dermatological side effects have included pruritus, burning, stinging, and tingling in 1% to 5% of patients using the 20% cream and up to 20% of patients using the 15% gel. Other side effects have included erythema, dryness, rash, peeling, irritation, dermatitis, edema, xerosis, photosensitivity, and contact dermatitis. There have been rare reports of vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening and exacerbation of recurrent herpes labialis in some patients.

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