Azelaic Acid Topical
Azelaic acid is a topical skin treatment used for the inflammatory bumps and pimples of mild to moderate rosacea.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Azelaic Acid Topical: Patient Information Guide
A plain-language walkthrough of Azelaic Acid Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Azelaic acid topical products are used to treat rosacea on the face. Specific approvals depend on the product:
- Azelaic Acid Gel 15% is indicated for the topical treatment of the inflammatory papules and pustules (red bumps and pimples) of mild to moderate rosacea.
- Finacea Foam is also indicated for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
- Neither product has been evaluated for treating the general facial redness (erythema) of rosacea when bumps and pimples are absent, even though some redness reduction was observed in clinical studies when both types of symptoms were present.
⚙️How it works▾
Azelaic acid works locally within the skin, though its exact mechanism in rosacea is not fully known. It has demonstrated antimicrobial activity against bacteria like Propionibacterium acnes and Staphylococcus epidermidis, possibly by interfering with their protein production. It may also help normalize how skin cells grow and shed, reducing the formation of clogged pores. Studies with Azelex cream showed a reduction in the thickness of the outer skin layer and key proteins involved in pore-clogging.
💊How it's taken▾
Azelaic acid is applied directly to the skin — never taken by mouth. The general schedule is twice daily, morning and evening. Cleanse the affected area with a gentle, mild cleanser and pat dry before applying a thin layer. Wash your hands right after use.
- Finacea Foam should be shaken before use and applied to the entire facial area
- Avoid occlusive (airtight) dressings, harsh cleansers, astringents, and exfoliating products
- Cosmetics may be applied after the product has dried
- Follow your prescriber's instructions and your specific product's label for complete guidance
🤒Side effects — in detail▾
The most common side effects with azelaic acid gel affect the skin at the application site:
- Burning, stinging, or tingling (reported in about 29% of users in clinical trials)
- Itching (pruritus) — about 11%
- Dry, flaking, or scaling skin — about 8%
- Redness or irritation — about 4%
These reactions are usually mild and most common in the first few weeks of treatment. If you develop severe or persistent irritation, stop using the product and contact your doctor. Serious allergic reactions — including facial swelling, difficulty breathing, or hives — are rare but require immediate medical attention.
⚠️Warnings & precautions▾
- Serious allergic reactions: Cases of angioedema (deep swelling under the skin), facial and eye swelling, difficulty breathing, and hives have been reported. Stop use immediately and get medical help if these occur.
- Skin irritation: Burning, stinging, and itching are common early in treatment. If irritation is severe or lasting, discontinue use and talk to your doctor.
- Skin lightening (hypopigmentation): Rare cases of lightened skin have been reported. Patients with darker complexions should be monitored closely for early signs.
- Eye and mucous membrane irritation: Keep the product away from your eyes and mouth. If it contacts your eyes, rinse well with water and see a doctor if irritation persists.
- Asthma worsening: Worsening of asthma has been reported. If you notice your asthma getting worse, consult your physician.
🔀What it interacts with▾
The FDA label for azelaic acid topical does not identify specific drug, food, or supplement interactions. However, certain skin product combinations may increase irritation:
- Alcoholic cleansers, tinctures, and astringents — may worsen skin irritation; avoid while using azelaic acid
- Abrasive cleansers and peeling agents — may increase skin sensitivity; avoid during treatment
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy: Do not use if you are allergic to azelaic acid or any ingredient in the product
- Asthma: Tell your doctor if you have asthma; worsening has been reported with azelaic acid use
- Darker skin tones: Rare skin lightening (hypopigmentation) has been reported — your doctor should monitor for early signs
- Pregnancy: Topical azelaic acid is minimally absorbed and not expected to reach the baby in meaningful amounts, but discuss with your healthcare provider before use
- Breastfeeding: Azelaic acid is naturally found in human milk; topical use is not expected to meaningfully change milk concentration or expose the infant — discuss with your doctor
- Children: The safety and effectiveness of Finacea Foam have not been established in pediatric patients
- Older adults: Clinical studies included adults 65 and older with no overall differences in safety or effectiveness, though some older individuals may be more sensitive
📡Pharmacodynamics — effects in the body▾
Azelaic acid works through local effects within the skin. Clinical studies of Finacea Foam indicate that its effectiveness in reducing rosacea symptoms is driven by these local skin-level actions rather than by systemic (whole-body) effects. After topical application, plasma concentrations and urinary excretion of azelaic acid are not meaningfully different from normal background levels.
🔬Pharmacokinetics — how your body processes it▾
Only a small amount of azelaic acid is absorbed through the skin after topical use — approximately 3–5% reaches the outer skin layer (stratum corneum) and up to 10% penetrates into deeper skin layers, with about 4% absorbed into the bloodstream. The body processes and eliminates it mainly through the urine, largely unchanged. The half-life (time for the body to clear half the absorbed amount) is roughly 12 hours after topical dosing, compared to about 45 minutes after oral dosing — meaning absorption through the skin is the rate-limiting step. Azelaic acid is also a natural dietary component found in whole grains and animal products, and the body produces small amounts on its own.
📦How to store it▾
Store at 25 ◦ C (77 ◦ F); excursions permitted between 15–30 ◦ C (59–86 ◦ F) . store at temperatures above 120°F (49°C).
📄 Written from Azelaic Acid Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Azelaic Acid Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is azelaic acid used for? ▾
My skin is burning and stinging after I apply it — is that normal? ▾
How do I apply Finacea Foam correctly? ▾
Can I use this if I'm pregnant or breastfeeding? ▾
I have asthma — should I be worried about using azelaic acid? ▾
How long does it take to see results, and how long do I need to use it? ▾
Is Azelaic Acid Topical available over the counter? ▾
When was Azelaic Acid Topical first available? ▾
Who makes Azelaic Acid Topical? ▾
💬 Answers drafted from Azelaic Acid Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Azelaic Acid Topical comes
Azelaic Acid Topical is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Azelaic Acid Gel 15% is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea
- Azelex cream: clinical studies showed antimicrobial activity and reduction of skin-layer changes associated with rosacea and acne-related conditions
- Apply to affected skin areas twice daily (morning and evening) in a thin layer
- Cleanse skin gently and pat dry before applying; avoid alcoholic cleansers, astringents, abrasives, and peeling agents
- Avoid contact with eyes, mouth, and mucous membranes — rinse with plenty of water if contact occurs
- For external use only — not for oral, eye, or intravaginal use
Inhaler
How this form is used
- Finacea Foam is used for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
- Finacea Foam: Shake well before use
- Finacea Foam: Cleanse the face with a mild soap or soapless cleanser and pat dry before applying
- Finacea Foam: Apply a thin layer twice daily (morning and evening) to the full face — cheeks, chin, forehead, and nose
- Finacea Foam: Wash hands immediately after applying; cosmetics may be applied once the foam has dried
📊 Azelaic Acid Topical across the U.S. market
How Azelaic Acid Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Azelaic Acid Topical is used
A general measure of how commonly Azelaic Acid Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Azelaic Acid Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Azelaic Acid Topical prescribed? Of the 1,596 medications we measure, Azelaic Acid Topical ranks #519 by Medicaid prescriptions — more than 67% of them.
Utilization by Azelaic Acid Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
azelaic acid 0.15 MG/MG Topical Gel
Summed across the 5 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1041518
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azelaic Acid Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 6 listed Azelaic Acid Topical NDCs with Medicaid activity.
🔍 Compare Azelaic Acid Topical products
A representative set of FDA-listed product records for Azelaic Acid Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhaler | ||||
| 0.15 g/g | Topical | LEO Pharma Inc. | NDA | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 0.15 g/g | Topical | A-S Medication Solutions × 3 listings | NDA | View NDC → |
| 0.15 g/g | Topical | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 0.2 g/g | Cutaneous | Almirall, LLC × 3 listings | NDA | View NDC → |
| 0.15 g/g | Topical | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 0.15 g/g | Topical | Bryant Ranch Prepack | ANDA | View NDC → |
| 0.15 g/g | Topical | Encube Ethicals, Inc. | ANDA | View NDC → |
| 0.15 g/g | Topical | Encube Ethicals Private Limited | ANDA | View NDC → |
| 0.15 g/g | Topical | Glenmark Pharmaceuticals Inc., USA × 2 listings | ANDA | View NDC → |
| 14 g/100 g | Topical | Guangdong Bisutang Biotechnology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 10 g/100 g | Topical | Guangzhou Ariel Medical Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 14 g/100 g | Topical | Guangzhou Ariel Medical Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 0.15 g/g | Topical | LEO Pharma Inc. | NDA | View NDC → |
| 0.15 g/g | Topical | Sandoz Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 0.15 g/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 0.15 g/g | Topical | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
Showing 22 of 22 products — FDA National Drug Code Directory. See every product, package size and price: browse all 22 Azelaic Acid Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Azelaic Acid Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Azelaic Acid Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Azelaic Acid Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 618278 3 dose forms · 5 strengths
-
Dose form (SCDF) Topical Cream RxCUI 618280In current FDA listingsClinical drug / strength (SCD) azelaic acid 100 MG/MLRxCUI 2746493azelaic acid 140 MG/MLRxCUI 2738813azelaic acid 200 MG/MLRxCUI 1041520 -
Dose form (SCDF) Topical Foam RxCUI 1659799In current FDA listingsClinical drug / strength (SCD) azelaic acid 150 MG/MLRxCUI 1659800 -
Dose form (SCDF) Topical Gel RxCUI 618283In current FDA listingsClinical drug / strength (SCD) azelaic acid 0.15 MG/MGRxCUI 1041518
Look up RxCUI 618278 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Azelaic Acid Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Azelaic Acid Topical belongs to the Other anti-acne preparations for topical use class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 10 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.