AZELEX
Generic: AZELAIC ACID
Basic Information
Manufacturer
Almirall, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
CUTANEOUS
FDA Set ID
ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75
Indications & Usage
INDICATIONS AND USAGE AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Warnings
WARNINGS AZELEX ® cream is for dermatologic use only and not for ophthalmic use.
There have been isolated reports of hypopigmentation after use of azelaic acid.
Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.
There have been isolated reports of hypopigmentation after use of azelaic acid.
Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.
Adverse Reactions
ADVERSE REACTIONS During U.S.
clinical trials with AZELEX ® cream, adverse reactions were generally mild and transient in nature.
The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling.
Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects.
There is the potential for experiencing allergic reactions with use of AZELEX ® cream.
In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
clinical trials with AZELEX ® cream, adverse reactions were generally mild and transient in nature.
The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling.
Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects.
There is the potential for experiencing allergic reactions with use of AZELEX ® cream.
In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.