Azelaic Acid Information
Pronunciation
(a zeh LAY ik AS id)
What is this drug used for?
• It is used to treat pimples (acne).
• It is used to treat rosacea.
Frequently reported side effects of this drug
• Itching
• Burning
• Stinging
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Shortness of breath
• Severe skin irritation
• Skin discoloration
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Storage/Stability
Store at 15°C to 30°C (59°F to 86°F); do not freeze. Store cream on its side. Discard the gel pump 8 weeks after opening.
Foam: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Flammable; avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 49°C (120°F). Discard 8 weeks after opening.
Adverse Reactions
>10%: Dermatologic: Burning sensation of skin (≤16%), stinging of skin (≤16%), tingling of skin (≤16%)
1% to 10%:
Dermatologic: Pruritus (1% to 6%), erythema (≤2%), skin irritation (≤2%), acne (gel: ≤1%), contact dermatitis (≤1%), desquamation (≤1%), xeroderma (≤1%), xerosis (≤1%)
Local: Application site pain (6%), application site pruritus (3%)
<1%, postmarketing, and/or case reports: Angioedema, application site erythema, dermatitis, dyspnea, edema, exacerbation of asthma, exacerbation of herpes labialis, facial edema, hypersensitivity reaction, hypertrichosis, hypopigmentation, iridocyclitis, local dryness, skin depigmentation (small spots), skin rash, swelling of eye, urticaria, vitiligo, wheezing
