azelaic acid Side Effects
Also known as: Finacea, Azelex
Analysis of 826 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
826
Death-Related
55
6.7% of reports
Hospitalizations
150
18.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 55 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | 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 |
| RASH | 25 |
| STOMATITIS | 25 |
| DRUG INTOLERANCE | 24 |
| OFF LABEL USE | 24 |
| PAIN | 24 |
| PRODUCT USE IN UNAPPROVED INDICATION | 24 |
| RHEUMATOID ARTHRITIS | 24 |
| SYNOVITIS | 24 |
| TASTE DISORDER | 24 |
| MIGRAINE | 23 |
Reactions in Hospitalization Reports
Top reactions in 150 reports where hospitalization was an outcome.
| Reaction | 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 |
| PARAESTHESIA | 28 |
| RHEUMATIC FEVER | 28 |
| BLEPHAROSPASM | 27 |
| EPILEPSY | 27 |
| RHEUMATOID ARTHRITIS | 27 |
| STOMATITIS | 27 |
| DRUG INTOLERANCE | 26 |
| DYSPNOEA | 26 |
| SWELLING | 26 |
| SYNOVITIS | 26 |
Nearby — Related Medications
What the FAERS Data Reveals About azelaic acid Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 826 voluntary reports linked to azelaic acid and its brand equivalents (Finacea, Azelex), spanning 2004 through 2025. Of those, 55 (6.7%) listed death as an outcome and 150 (18.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 84% were female and 16% male; age distribution skews toward 18-44, with 246 reports in that bracket. The single most reported reaction is drug ineffective with 140 submissions, followed by pain and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.