Azelaic Acid
Azelaic acid is a topical medication used to treat acne and rosacea. It works by reducing bacteria on the skin and decreasing inflammation. This prescription and over-the-counter medication is suitable for various skin types and is often recommended as an alternative for those who cannot tolerate other acne treatments.
Azelaic acid is a topical treatment for acne and rosacea that works by reducing skin bacteria and inflammation.
Key facts at a glance
- RxNorm
- 18602
- Generic
- Azelaic Acid
- Class
- pin-variant
- Brands
- NicAzel, Azelex, Finacea
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- —
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesterno_adjustment_required
use only if clearly needed, topical application poses minimal systemic absorption
standard prenatal care
pregnancy
second trimesterno_adjustment_required
continue as prescribed for acne or rosacea treatment
standard prenatal care
pregnancy
third trimesterno_adjustment_required
safe for continued use
standard prenatal care
lactation
generalavoid_application_on_breast_area
do not apply to breasts before nursing, wash hands thoroughly before handling infant
monitor infant for skin irritation
Use with caution and monitor for adverse effects.
pediatric_age
adolescents 12 and olderno_adjustment_required
approved for use in patients 12 years and older for acne treatment
monitor for skin irritation
geriatric
generalno_adjustment_required
no specific dose adjustment needed for elderly patients
standard monitoring
renal_impairment
mild to moderateno_adjustment_required
topical application results in minimal systemic absorption, no dose adjustment needed
standard monitoring
hepatic_impairment
mild to moderateno_adjustment_required
topical application results in minimal systemic absorption, no dose adjustment needed
standard monitoring
Statistics and clinical data
FDA Approval Year
FDA approval for azelaic acid topical formulation
Drug class
ATC classification for azelaic acid
Primary indications
FDA-approved therapeutic indications
Common formulations
Available pharmaceutical formulations
Azelaic acid is primarily used to treat mild to moderate acne vulgaris and inflammatory papulopustular rosacea. It may also help with post-inflammatory hyperpigmentation and is sometimes prescribed for other dermatological conditions as determined by a healthcare provider.
Azelaic acid exhibits antibacterial properties against acne-causing bacteria and has anti-inflammatory effects that help reduce redness and swelling. It also helps normalize the skin cell turnover process and may reduce keratinocyte proliferation.
Common side effects include mild skin irritation, burning, or dryness especially during the initial treatment period. It is generally considered safe for most adults but should be used as directed. Pregnant or breastfeeding individuals should consult their healthcare provider before use. Results typically become visible after several weeks of consistent application.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy