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AZELEX

Generic: azelaic acid

Verified·Apr 23, 2026
Manufacturer
Almirall
NDC
16110-869
RxCUI
1041520
Route
CUTANEOUS
ICD-10 indication
L70.0

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About AZELEX

What is this medication?

Azelex is a prescription topical cream containing 20 percent azelaic acid, which is primarily used to treat mild-to-moderate inflammatory acne vulgaris. It belongs to a class of medications known as dicarboxylic acids and is intended for patients who need a targeted treatment for skin blemishes and inflammation. This medication is typically applied to the skin twice a day as part of a regular dermatological routine to improve the overall appearance and health of the skin.

This medication works by inhibiting the growth of acne-causing bacteria and decreasing the production of keratin, a protein that can block pores and lead to breakouts. By reducing the concentration of these bacteria and preventing the buildup of skin cells, the cream helps to clear up existing acne and prevent new pimples or blackheads from forming. It is considered an effective option for managing skin clarity and reducing the inflammatory response associated with common acne conditions.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for AZELEX. Official source: DailyMed (NLM) · Label effective Mar 4, 2024

Indications and usage
INDICATIONS AND USAGE AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Dosage and administration
DOSAGE AND ADMINISTRATION 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.
Contraindications
CONTRAINDICATIONS AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
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.
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.
Use in pregnancy
Pregnancy Teratogenic Effects Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How AZELEX appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

3%

175 of 5,509 plans

Most common tier

Tier 4

On 78% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)4
17%
Tier 3 (preferred brand)1
4%
Tier 4 (non-preferred brand)18
78%

Step therapy: 9% of formularies

Quantity limits: 4% of formularies

Coverage breadth: 23 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.