HIGH-VOLUME · SEX-BALANCED
isotretinoin Side Effects
isotretinoin (also sold as Accutane, Absorica) is HIGH-VOLUME in this FAERS book #146 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 64% of sex-coded reports are female (25,112 F / 14,173 M).
Data updated 2026-05-15
- 47,513
- FAERS reports
FAERS voluntary reports, 2000 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
isotretinoin reporting skew - 64% of sex-coded reports are female (25,112 F / 14,173 M). Volume band HIGH-VOLUME #146 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for isotretinoin (Accutane): 47,513 FAERS rows (2000-2025). Top named reactions: DEPRESSION, INFLAMMATORY BOWEL DISEASE, COLITIS ULCERATIVE. Outcome stamps DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2000–2025). Stamps CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
DEPRESSION leads 5,699 of 47,513 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (14,158 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 878 reports (1.8% - MARKED). Reactions below co-occur in those rows only.
| 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
Hospitalization is lighter here (4,281). Reactions in that subset:
| 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 |
How to read isotretinoin FAERS figures (CASELOAD · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 47,513 voluntary reports linked to isotretinoin (Accutane, Absorica), 2000-2025. Death is listed on 878 (1.8%). Hospitalization appears on 4,281 (9.0%). Top co-reported indication: Acne.
CASELOAD books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with isotretinoin
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 47,426 FAERS cases (Δ 87 lighter vs isotretinoin); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 47,788 FAERS cases (Δ 275 heavier vs isotretinoin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 47,215 FAERS cases (Δ 298 lighter vs isotretinoin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 47,843 FAERS cases (Δ 330 heavier vs isotretinoin); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 60.3 pp vs isotretinoin's DEATH-MARKED): CASELOAD · HOSP-MID.
isotretinoin sits in CASELOAD; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.