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Azelaic Acid

    DEA Class; Rx

    Common Brand Names; Azelex, Finacea

    •  Acne Agents, Topical

    Treatment for acne vulgaris and rosacea associated with inflammatory pustules and papules
    Only topical formulations (cream, gel, foam) are marketed in the United States
    Azelaic acid is a naturally occurring dietary constituent and can be formed endogenously

    Indicated for the treatment of mild-to-moderate inflammatory acne vulgaris.

    For the treatment of inflammatory pustules and papules of mild-to-moderate acne rosacea.
    For the treatment of melasma.
    For the treatment of lentigo maligna in which surgery is contraindicated.
    For the treatment of cutaneous malignant melanoma.

    Hypersensitivity to azelaic acid, propylene glycol or any of its components

    • Burning/ stinging/ tingling (4-16%)
    • Pruritus (1-6%)
    • Scaling/ dry skin/ xerosis (1-5%)
    • Erythema/ irritation (1-2%)
    • Contact dermatitis
    • Edema
    • Acne

    In case of known hypersensitivity to any component of the gel, avoid the use of gel dosage form; if hypersensitivity develops during treatment, discontinue and institute appropriate therapy

    For dermatologic use only

    Therapy has been reported to cause irritation of eyes; avoid contact with eyes and mucous membranes; if medication comes in contact with eyes, wash eyes with large amounts of water and consult a physician if eye irritation persists

    Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation

    Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during first few weeks of treatment; if sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy

    Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)

    Avoid any foods and beverages that provoke erythema, flushing, and blushing (eg, alcoholic beverages, spicy food, hot drinks such as hot coffee and tea)

    Report any abnormal changes in skin color to physician

    Avoid use of occlusive dressings or wrappings

    Wash hands after applying the cream

    Worsening of asthma reported; consult a physician if asthma is exacerbated with therapy

    Azelaic acid is minimally absorbed systemically following topical route of administration; maternal use not expected to result in fetal exposure to drug

    Azelaic acid is naturally present in human milk; when used as prescribed, azelaic acid is unlikely to be absorbed through skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of infant to drug

    No maximum dosage information is available.

    Azelaic Acid


    • 20% (Azelex)


    • 15% (Finacea)


    • 15% (Finacea)