azelaic acid

Name: azelaic acid — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

Verify with FDA → · CMS NADAC pricing →

Brand names: Finacea, Azelex

Topical Dicarboxylic Acid Rx

Azelaic acid gel is a topical medicine that helps treat rosacea. It reduces redness and bumps on your face.

Drug Pricing (NADAC)

Brand Price

$8.36/unit

Generic Price

$0.56/unit

Generic Savings

93%

Generic Available

Yes (4 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

This medicine treats mild to moderate rosacea.

Common side effects

Burning, stinging, or tingling, Itching, Dry or scaling skin

Key warnings

If you have a known allergy to any ingredient in this gel, do not use it.

How It Works

Azelaic acid is a naturally occurring acid. It works by reducing inflammation. It also slows the growth of skin cells that can block pores.

How to Take It

Before applying, gently clean the affected skin with a mild soap or soapless cleanser. Pat your skin dry with a soft towel. Apply a thin layer of azelaic acid gel to the affected areas of your face twice a day, once in the morning and once in the evening. Wash your hands right after using the gel. You can put on makeup after the gel dries.

Pregnancy & Breastfeeding

Azelaic acid is not likely to harm your unborn baby. It is also not expected to pass into breast milk in amounts that could harm a nursing baby. Talk to your doctor if you are pregnant or breastfeeding.

Missed Dose

Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature, between 68°F to 77°F.

Side Effects (from patient reports)

Based on 922 FDA adverse event reports.

The medicine did not work

140

Pain

109

Using the medicine for a condition it is not approved for

101

Throwing up

Upper stomach pain

Acid reflux

Migraine headache

Numbness or tingling

Using the product for a condition it is not approved for

Reduced sense of touch

FDA Adverse Event Report Analysis

Detailed analysis of 826 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

826

Death-Related Reports

Hospitalization Reports

150

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 589 (84%)

Male 110 (16%)

Age Distribution

0–17 23

18–44 246

45–64 134

65–74 63

75+ 43

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
1	DRUG INEFFECTIVE	140
2	PAIN	109
3	OFF LABEL USE	101
4	VOMITING	91
5	ABDOMINAL PAIN UPPER	84
6	GASTROOESOPHAGEAL REFLUX DISEASE	83
7	MIGRAINE	81
8	PARAESTHESIA	78
9	PRODUCT USE IN UNAPPROVED INDICATION	78
10	HYPOAESTHESIA	77
11	MEMORY IMPAIRMENT	77
12	RASH	75
13	DRUG INTOLERANCE	74
14	BLEPHAROSPASM	73
15	EPILEPSY	73

Reactions in Death Reports

GASTROOESOPHAGEAL REFLUX DISEASE 28

DRUG INEFFECTIVE 27

HYPOAESTHESIA 27

VOMITING 27

PARAESTHESIA 26

RHEUMATIC FEVER 26

ABDOMINAL PAIN UPPER 25

BLEPHAROSPASM 25

EPILEPSY 25

MEMORY IMPAIRMENT 25

Reactions in Hospitalization Reports

VOMITING 34

PAIN 32

RASH 32

DRUG INEFFECTIVE 31

GASTROOESOPHAGEAL REFLUX DISEASE 31

ABDOMINAL PAIN UPPER 30

OFF LABEL USE 30

HYPOAESTHESIA 29

MIGRAINE 29

MEMORY IMPAIRMENT 28

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

If you have a known allergy to any ingredient in this gel, do not use it. Stop using this medicine and get medical help if you have a severe allergic reaction. This medicine can cause skin irritation, eye irritation, and may worsen asthma. Watch for changes in skin color, especially if you have dark skin.

Common Questions

Can I use other skincare products with this gel?

Yes, you can use cosmetics after the gel has dried.

How long does it take to see results?

If you do not see improvement after 12 weeks, talk to your doctor.

Can I use this gel on other parts of my body?

This gel is for topical use on the face only. Do not use it in your mouth, eyes, or vagina.

What should I avoid while using this gel?

Avoid using harsh cleansers, alcohol-based products, and abrasive or peeling agents.

What if I get the gel in my eyes?

Wash your eyes with plenty of water. If irritation continues, see a doctor.

Can this gel make my asthma worse?

Yes, it can. Talk to your doctor if your asthma gets worse.

Will this gel change my skin color?

In rare cases, it can cause skin lightening. If you have dark skin, watch for this.

What should I do if my skin gets very irritated?

Stop using the gel and talk to your doctor.

Is it okay to use a bandage over the gel?

No, avoid using bandages or wraps over the treated area.

How often should I apply this gel?

Apply a thin layer to the affected areas twice a day, in the morning and evening.

What are the common side effects of azelaic acid?

The most commonly reported side effects of azelaic acid include Burning, stinging, or tingling, Itching, Dry or scaling skin, Redness or irritation. Based on 922 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

What drug class is azelaic acid?

azelaic acid belongs to the Topical Dicarboxylic Acid drug class. It requires a prescription (Rx). This medicine treats mild to moderate rosacea.

Is there a generic version of azelaic acid?

Yes, generic azelaic acid is available from 4 manufacturers. The generic costs $0.56 per unit compared to $8.36 for the brand version, saving approximately 93%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.

Is azelaic acid safe during pregnancy?

Azelaic acid is not likely to harm your unborn baby. It is also not expected to pass into breast milk in amounts that could harm a nursing baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has azelaic acid been recalled?

There is 1 recall associated with azelaic acid products. CGMP Deviations: Market complaints received for gritty texture (grainy). Check the recalls section below for full details and affected products.

Active Recalls

Class II September 17, 2025

CGMP Deviations: Market complaints received for gritty texture (grainy)

Glenmark Pharmaceuticals Inc., USA

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What the FDA Data Shows for azelaic acid

The FDA label for azelaic acid (sold under brand names such as Finacea, Azelex) classifies it as a prescription-only medication in the Topical Dicarboxylic Acid class. This medicine treats mild to moderate rosacea. Official labeling lists 4 commonly reported side effects, including Burning, stinging, or tingling, Itching, Dry or scaling skin.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 922 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.56 versus $8.36 for the brand — a 93% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 23, 2021

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages