Skip to Content

Azelex Side Effects

Generic Name: azelaic acid topical

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

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:

More common
  • Burning, stinging, or tingling of the skin
  • dryness, itching, peeling, or redness of the skin
Less common
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • scaling, severe redness, soreness, or swelling of the skin
Incidence not known
  • Fast heartbeat
  • fever
  • hives, itching, or skin rash
  • hoarseness
  • irritation
  • 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

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:

Rare
  • Change in skin color at treated areas
Incidence not known
  • Blurred vision
  • eye pain
  • eye redness
  • tearing

For Healthcare Professionals

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

General

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]

Local

Cream:
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

Foam:
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

Gel:
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
Uncommon (0.1% to 1%): Application site exfoliation, application site warmth, application site discoloration, application site discomfort, application site urticaria[Ref]

Skin irritation usually resolved during continued treatment.[Ref]

Dermatologic

Skin irritation usually regressed during the course of treatment.[Ref]

Cream:
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

Foam:
Frequency not reported: Hypopigmentation
Postmarketing reports: Rash

Gel:
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]

Cardiovascular

Gel:
Common (1% to 10%): Edema[Ref]

Gastrointestinal

Cream:
Uncommon (0.1% to 1%): Cheilitis[Ref]

Hypersensitivity

Cream:
Rare (0.01% to 0.1%): Drug hypersensitivity
Frequency not reported: Allergic reactions, angioedema, hypersensitivity

Foam:
Postmarketing reports: Hypersensitivity

Gel:
Rare (0.01% to 0.1%): Angioedema, hypersensitivity
Very rare (less than 0.01%): Allergic skin reactions[Ref]

Respiratory

Cream:
Rare (0.01% to 0.1%): Worsening of asthma

Foam:
Postmarketing reports: Worsening of asthma

Gel:
Rare (0.01% to 0.1%): Dyspnea, worsening of asthma
Postmarketing reports: Wheezing[Ref]

Ocular

Iridocyclitis occurred with accidental administration to the eyes.[Ref]

Cream:
Frequency not reported: Eye swelling

Foam:
Frequency not reported: Eye irritation

Gel:
Rare (0.01% to 0.1%): Eye swelling
Postmarketing reports: Iridocyclitis[Ref]

References

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

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

4. Cerner Multum, Inc. "Australian Product Information." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide