Prescription medication · Topical Dicarboxylic Acid
azelaic acid
Also sold as Finacea, Azelex. This medicine treats mild to moderate rosacea.
Data updated 2026-05-15
- 826
- FDA reportsRarely reported
- 93% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
azelaic acid (Finacea) is a prescription Topical Dicarboxylic Acid, among the least-reported drugs the FDA tracks (826 FDA reports), whose generic costs a fraction of the brand (about 93% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
azelaic acid (Finacea) is a prescription Topical Dicarboxylic Acid. This medicine treats mild to moderate rosacea.
Azelaic acid gel is a topical medicine that helps treat rosacea. It reduces redness and bumps on your face.
Verify with FDA → · CMS NADAC pricing →
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 →
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.
The sections below are summarized in plain English from azelaic acid's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 826 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for azelaic acid, by number of reports
- Pain
Pain
109 reports
- Vomiting
Vomiting
91 reports
- Abdominal Pain Upper
Abdominal Pain Upper
84 reports
- Gastrooesophageal Reflux Disease
Gastrooesophageal Reflux Disease
83 reports
- Migraine
Migraine
81 reports
- Paraesthesia
Paraesthesia
78 reports
- Hypoaesthesia
Hypoaesthesia
77 reports
- Memory Impairment
Memory Impairment
77 reports
- Rash
Rash
75 reports
- Blepharospasm
Blepharospasm
73 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for azelaic acid each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where azelaic acid sits
azelaic acid has more FDA adverse-event reports than 5% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is azelaic acid; the line is the median (50th percentile).
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
Reports Mentioning Death
55
6.7% of reports — not proof of cause
Hospitalization Reports
150
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PAIN | 109 |
| 4 | VOMITING | 91 |
| 5 | ABDOMINAL PAIN UPPER | 84 |
| 6 | GASTROOESOPHAGEAL REFLUX DISEASE | 83 |
| 7 | MIGRAINE | 81 |
| 8 | PARAESTHESIA | 78 |
| 10 | HYPOAESTHESIA | 77 |
| 11 | MEMORY IMPAIRMENT | 77 |
| 12 | RASH | 75 |
| 14 | BLEPHAROSPASM | 73 |
| 15 | EPILEPSY | 73 |
| 16 | TASTE DISORDER | 72 |
| 17 | CONDITION AGGRAVATED | 49 |
| 18 | NAUSEA | 48 |
| 19 | DIARRHOEA | 45 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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?
How long does it take to see results?
Can I use this gel on other parts of my body?
What should I avoid while using this gel?
What if I get the gel in my eyes?
Can this gel make my asthma worse?
Will this gel change my skin color?
What should I do if my skin gets very irritated?
Is it okay to use a bandage over the gel?
How often should I apply this gel?
What are the common side effects of azelaic acid?
What drug class is azelaic acid?
Is there a generic version of azelaic acid?
What pregnancy or breastfeeding source fields are listed for azelaic acid?
Has azelaic acid been recalled?
Active Recalls
CGMP Deviations: Market complaints received for gritty texture (grainy)
Glenmark Pharmaceuticals Inc., USA
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for azelaic acid: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 826.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.66%.
- cefixime Δ 0.00 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- ibuprofen Δ 0.01 pts · 262,453 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 6.66%death share
- ketoconazole Δ 0.01 pts · 16,231 reports · Azole Antifungal 6.65%death share
- polyethylene glycol 3350 Δ 0.01 pts · 91,655 reports · Osmotic Laxative 6.65%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 826 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: December 23, 2021
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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