Note: This document contains side effect information about azelaic acid topical. Some dosage forms listed on this page may not apply to the brand name Finacea.

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

Serious side effects of Finacea

Along with its needed effects, azelaic acid topical (the active ingredient contained in Finacea) 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

• Blurred vision
• eye pain, redness, or swelling
• 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
• tearing
• tightness in the chest
• trouble breathing or swallowing

Other side effects of Finacea

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

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

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]

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