Azelaic acid topical Side Effects

Not all side effects for azelaic acid topical may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to azelaic acid topical: topical cream, topical gel/jelly

In addition to its needed effects, some unwanted effects may be caused by azelaic acid topical. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking azelaic acid topical, check with your doctor or nurse as soon as possible:

Rare
  • White spots or lightening of treated areas of dark skin—in patients with dark complexions, although usually not lightened beyond normal skin color

Some of the side effects that can occur with azelaic acid topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Burning, stinging, or tingling of skin, mild
  • dryness of skin
  • itching of skin
  • peeling of skin
  • redness of skin

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.[Ref]

Respiratory

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

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.[Ref]

References

1. "Product Information. Finacea (azelaic acid topical)." Berlex Laboratories, Richmond, CA.

2. Fitton A, Goa KL "Azelaic acid. A review of its pharmacological properties and therapeutic efficacy in acne and hyperpigmentary skin disorders." Drugs 41 (1991): 780-98

3. Maddin S "A comparison of topical azelaic acid 20% cream and topical metronidazole 0.75% cream in the treatment of patients with papulopustular rosacea." J Am Acad Dermatol 40 (1999): 961-5

4. Gupta AK, Gover MD "Azelaic acid (15% gel) in the treatment of acne rosacea." Int J Dermatol 46 (2007): 533-8

5. "Product Information. Azelex (azelaic acid)." Allergan Inc, Irvine, CA.

6. Thiboutot D, Thieroff-Ekerdt R, Graupe K "Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: Results from two vehicle-controlled, randomized phase III studies." J Am Acad Dermatol 48 (2003): 836-45

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