Azelex Side Effects
Generic Name: azelaic acid topical
Medically reviewed by Drugs.com. Last updated on May 4, 2020.
Note: This document contains side effect information about azelaic acid topical. Some of the dosage forms listed on this page may not apply to the brand name Azelex.
For the Consumer
Applies to azelaic acid topical: topical cream, topical foam, topical gel/jelly
Side effects requiring immediate medical attention
Along with its needed effects, azelaic acid topical (the active ingredient contained in Azelex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking azelaic acid topical:
- Burning, stinging, or tingling of the skin
- dryness, itching, peeling, or redness of the skin
- Blistering, burning, crusting, dryness, or flaking of the skin
- scaling, severe redness, soreness, or swelling of the skin
Incidence not known
- Fast heartbeat
- hives, itching, or skin rash
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- swelling of the eyes
- tightness in the chest
- troubled breathing or swallowing
Side effects not requiring immediate medical attention
Some side effects of azelaic acid topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Change in skin color at treated areas
Incidence not known
For Healthcare Professionals
Applies to azelaic acid topical: compounding powder, topical cream, topical foam, topical gel, topical kit
Cream: The most commonly reported side effects included pruritus, burning, stinging, and tingling.
Foam: The most commonly reported side effects included application site pain, pruritus, dryness, and erythema.
Gel: The most commonly reported side effects included burning, stinging, tingling, and pruritus.[Ref]
Common (1% to 10%): Application site burning, application site discoloration, application site dryness, application site erythema, application site exfoliation, application site irritation, application site pain, application site pruritus, stinging, tingling
Uncommon (0.1% to 1%): Application site dermatitis, application site discomfort, application site edema, application site paresthesia
Rare (0.01% to 0.1%): Application site eczema, application site ulcer, application site vesicles, application site warmth
Common (1% to 10%): Application site pain/burning/stinging/paresthesia/tenderness, application site pruritus
Uncommon (0.1% to 1%): Application site dryness, application site erythema
Frequency not reported: Mucous membrane irritation
Very common (10% or more): Burning/stinging/tingling (up to 29%), dryness/tightness/scaling (up to 19.4%), erythema/irritation/redness (up to 19.4%)
Common (1% to 10%): Application site dryness, application site edema, application site pain, application site paresthesia, application site pruritus, application site rash, xerosis
Skin irritation usually resolved during continued treatment.[Ref]
Uncommon (0.1% to 1%): Acne, seborrhea, skin depigmentation
Frequency not reported: Contact dermatitis, dermatitis, exacerbation of recurrent herpes labialis, face swelling, hypertrichosis, keratosis pilaris, peeling, rash, reddening, small depigmented spots, urticaria, vitiligo depigmentation
Frequency not reported: Hypopigmentation
Postmarketing reports: Rash
Very common (10% or more): Itching (up to 19.4%), pruritus (up to 11%)
Common (1% to 10%): Acne, contact dermatitis, dry skin
Uncommon (0.1% to 1%): Folliculitis, skin disorder
Rare (0.01% to 0.1%): Face swelling, skin irritation/irritation, urticaria
Frequency not reported: Depigmentation, exacerbation of recurrent herpes labialis, hypertrichosis, keratosis pilaris, reddening, skin discoloration, small depigmented spots, temporary skin depigmentation, vitiligo[Ref]
Skin irritation usually regressed during the course of treatment.[Ref]
Common (1% to 10%): Edema[Ref]
Uncommon (0.1% to 1%): Cheilitis[Ref]
Rare (0.01% to 0.1%): Drug hypersensitivity
Postmarketing reports: Hypersensitivity
Rare (0.01% to 0.1%): Angioedema, hypersensitivity
Very rare (less than 0.01%): Allergic skin reactions[Ref]
Rare (0.01% to 0.1%): Worsening of asthma
Postmarketing reports: Worsening of asthma
Rare (0.01% to 0.1%): Dyspnea, worsening of asthma
Postmarketing reports: Wheezing[Ref]
Iridocyclitis occurred with accidental administration to the eyes.[Ref]
Frequency not reported: Eye swelling
Frequency not reported: Eye irritation
Rare (0.01% to 0.1%): Eye swelling
Postmarketing reports: Iridocyclitis[Ref]
1. "Product Information. Azelex (azelaic acid)." Allergan Inc, Irvine, CA.
2. "Product Information. Finacea (azelaic acid topical)." Berlex Laboratories, Richmond, CA.
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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More about Azelex (azelaic acid topical)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 9 Reviews
- Drug class: topical acne agents
- FDA Alerts (1)
- Other brands
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.