tretinoin Side Effects
Also known as: Retin-A
Analysis of 7,629 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
7,629
Death-Related
804
10.5% of reports
Hospitalizations
1,549
20.3% 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 804 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| MATERNAL EXPOSURE DURING PREGNANCY | 212 |
| OFF LABEL USE | 179 |
| DRUG INEFFECTIVE | 172 |
| PRODUCT USE IN UNAPPROVED INDICATION | 153 |
| PNEUMONIA | 147 |
| DRUG INTOLERANCE | 145 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 144 |
| TASTE DISORDER | 144 |
| CONDITION AGGRAVATED | 143 |
| VOMITING | 143 |
| EPILEPSY | 139 |
| SYNOVITIS | 139 |
| PRODUCT USE ISSUE | 137 |
| TREATMENT FAILURE | 135 |
| PRODUCT QUALITY ISSUE | 134 |
| RHEUMATOID ARTHRITIS | 134 |
| ABDOMINAL PAIN UPPER | 131 |
| WEIGHT INCREASED | 131 |
| PAIN | 130 |
| PSORIATIC ARTHROPATHY | 129 |
Reactions in Hospitalization Reports
Top reactions in 1,549 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 241 |
| PAIN | 198 |
| VOMITING | 195 |
| DRUG INEFFECTIVE | 185 |
| NAUSEA | 174 |
| DIARRHOEA | 173 |
| PNEUMONIA | 150 |
| ARTHRALGIA | 144 |
| DEPRESSION | 138 |
| HEADACHE | 138 |
| DYSPNOEA | 132 |
| FATIGUE | 132 |
| RASH | 132 |
| DIZZINESS | 131 |
| DRUG INTOLERANCE | 131 |
| PYREXIA | 130 |
| ASTHENIA | 128 |
| WEIGHT INCREASED | 124 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 122 |
| ABDOMINAL PAIN UPPER | 120 |
Nearby — Related Medications
What the FAERS Data Reveals About tretinoin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 7,629 voluntary reports linked to tretinoin and its brand equivalents (Retin-A), spanning 2004 through 2025. Of those, 804 (10.5%) listed death as an outcome and 1,549 (20.3%) 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, 76% were female and 23% male; age distribution skews toward 18-44, with 2,071 reports in that bracket. The single most reported reaction is off label use with 897 submissions, followed by drug ineffective and pain.
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.