azelex
Azelex (Azelaic Acid) is a medication used to treat Acne Vulgaris, Rosacea.
Azelaic Acid · by Almirall
Key facts
- Active ingredient
- Azelaic Acid
- Form
- Topical
- Strength
- Azelaic Acid 20%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- acne vulgaris, rosacea
- Manufacturer
- Almirall
- What the pharmacy pays
- ~$0.46 per gm — not your price
- FDA application
- NDA020428
What is Azelex?
From the FDA label:AZELEX ® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Structural Formula: HOOC-(CH 2 ) 7 -COOH Chemical Name: 1,7-heptanedicarboxylic acid Empirical Formula: C 9 H 16 O 4 Molecular Weight: 188.22 Active Ingredient: Each gram of AZELEX ® contains azelaic acid......... 0.2 g (20% w/w). Inactive Ingredients: cetearyl octanoate; cetostearyl alcohol; glycerin; glyceryl mono and dipalmitostearate; glyceryl monostearate; isopropyl myristate; PEG-30 stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.
How to use
After the skin is thoroughly washed and patted dry, a thin film of AZELEX ® cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX ® cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.
Side effects
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.
Warnings
Important safety information
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.
Who should not take Azelex
AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Azelex treat?
- Azelex (Azelaic Acid) may be used to treat acne vulgaris, rosacea, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Azelex cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.46 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Azelex?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Azelex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Azelex?
- Azelex is marketed by Almirall. You can see Almirall's full profile, rating, and other products on pharmaranks.
- Is Azelex a brand-name or generic drug?
- Azelex is a brand-name product with the active ingredient Azelaic Acid.
- Is Azelex available over the counter?
- No. Azelex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Azelex come in?
- Azelex is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Azelex FDA-registered?
- Azelex is on record with the U.S. FDA under application number NDA020428. You can verify this on its official FDA label.
- Has Azelex been recalled by the FDA?
- Azelex has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Azelex safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Azelex. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Azelex?
- Azelex's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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