Azelaic acid topical Side Effects

Some side effects of azelaic acid topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to azelaic acid topical: topical cream, topical gel, topical kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking azelaic acid topical: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• severe burning, stinging, or warmth;

• severe itching or tingling;

• severe redness, dryness, peeling, or other irritation; or

• changes in skin color.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to azelaic acid topical: compounding powder, topical cream, topical gel, topical kit

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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