Drug side effects
isotretinoin Side Effects
The reactions most often reported to the FDA for isotretinoin (also sold as Accutane, Absorica), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 47,513
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2000 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of isotretinoin come from 47,513 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 47,513 reports to the FDA Adverse Event Reporting System (FAERS) for isotretinoin (Accutane): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
47,513
Reports Mentioning Death
878
1.8% of reports — not proof the medicine caused the death
Hospitalizations
4,281
9.0% of reports
Top Indication
Acne
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 878 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 258 |
| COMPLETED SUICIDE | 254 |
| DEPRESSION | 71 |
| ROAD TRAFFIC ACCIDENT | 29 |
| SUICIDAL IDEATION | 28 |
| DRY SKIN | 27 |
| LIP DRY | 27 |
| DISEASE PROGRESSION | 26 |
| ADVERSE EVENT | 24 |
| ANXIETY | 21 |
| INFLAMMATORY BOWEL DISEASE | 21 |
| NEUROBLASTOMA | 21 |
| FATIGUE | 20 |
| GUN SHOT WOUND | 19 |
| ACUTE MYELOID LEUKAEMIA | 18 |
| COLITIS ULCERATIVE | 18 |
| MALIGNANT NEOPLASM PROGRESSION | 18 |
| CARDIOVASCULAR DISORDER | 17 |
| CARDIAC ARREST | 16 |
Reactions in Hospitalization Reports
Top reactions in 4,281 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| INFLAMMATORY BOWEL DISEASE | 1,650 |
| DEPRESSION | 1,238 |
| COLITIS ULCERATIVE | 1,146 |
| CROHN^S DISEASE | 612 |
| IRRITABLE BOWEL SYNDROME | 564 |
| CROHN'S DISEASE | 461 |
| SUICIDAL IDEATION | 452 |
| COLITIS | 418 |
| ANXIETY | 397 |
| DRY SKIN | 375 |
| RECTAL HAEMORRHAGE | 368 |
| INTESTINAL OBSTRUCTION | 365 |
| ABDOMINAL PAIN | 346 |
| INTESTINAL HAEMORRHAGE | 337 |
| LIP DRY | 310 |
| GASTROINTESTINAL INJURY | 297 |
| HEADACHE | 286 |
| ARTHRALGIA | 281 |
| GASTROINTESTINAL DISORDER | 275 |
| ANAEMIA | 267 |
Nearby, Related Medications
What the FAERS Data Reveals About isotretinoin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 47,513 voluntary reports linked to isotretinoin and its brand equivalents (Accutane, Absorica), spanning 2000 through 2025. Of those, 878 (1.8%) listed death as an outcome and 4,281 (9.0%) involved hospitalization. The most common indication reported alongside adverse events was Acne.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 63% were female and 36% male; age distribution skews toward 18-44, with 14,158 reports in that bracket. The single most reported reaction is depression with 5,699 submissions, followed by inflammatory bowel disease and colitis ulcerative.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to isotretinoin's 47,513.
Read our methodology - how this data is sourced, computed, and verified.