HIGH-VOLUME · SEX-BALANCED
apremilast Side Effects
apremilast (also sold as Otezla) is HIGH-VOLUME in this FAERS book #45 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 66% of sex-coded reports are female (90,394 F / 46,320 M).
Data updated 2026-05-15
- 143,174
- FAERS reports
FAERS voluntary reports, 2012 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
apremilast reporting skew - 66% of sex-coded reports are female (90,394 F / 46,320 M). Volume band HIGH-VOLUME #45 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for apremilast (Otezla): 143,174 FAERS rows (2012-2025). Top named reactions: DIARRHOEA, NAUSEA, PSORIASIS. Outcome stamps DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2012–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
DIARRHOEA leads 24,315 of 143,174 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (40,417 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 5,453 reports (3.8% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,750 |
| TYPE 2 DIABETES MELLITUS | 1,746 |
| PSORIATIC ARTHROPATHY | 1,731 |
| GLOSSODYNIA | 1,729 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,721 |
| RASH | 1,714 |
| SYNOVITIS | 1,712 |
| HYPOAESTHESIA | 1,707 |
| INFUSION RELATED REACTION | 1,704 |
| HYPERTENSION | 1,703 |
| RHEUMATOID ARTHRITIS | 1,695 |
| WOUND | 1,677 |
| HAND DEFORMITY | 1,667 |
| JOINT SWELLING | 1,630 |
| HEPATIC ENZYME INCREASED | 1,621 |
| FIBROMYALGIA | 1,617 |
| SWELLING | 1,607 |
| HELICOBACTER INFECTION | 1,580 |
| DUODENAL ULCER PERFORATION | 1,578 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (10,932). Reactions in that subset:
| Reaction | Reports |
|---|---|
| PSORIATIC ARTHROPATHY | 2,086 |
| RASH | 2,053 |
| FATIGUE | 2,009 |
| DIARRHOEA | 1,929 |
| RHEUMATOID ARTHRITIS | 1,924 |
| HEADACHE | 1,920 |
| NAUSEA | 1,917 |
| SYNOVITIS | 1,894 |
| PAIN | 1,893 |
| JOINT SWELLING | 1,834 |
| ARTHRALGIA | 1,822 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,798 |
| VOMITING | 1,795 |
| INFUSION RELATED REACTION | 1,779 |
| HYPERTENSION | 1,774 |
| ARTHROPATHY | 1,769 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,718 |
| MALAISE | 1,716 |
How to read apremilast FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 143,174 voluntary reports linked to apremilast (Otezla), 2012-2025. Death is listed on 5,453 (3.8%). Hospitalization appears on 10,932 (7.6%). Top co-reported indication: Psoriasis.
MEGA-CASE books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with apremilast
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 140,497 FAERS cases (Δ 2,677 lighter vs apremilast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 150,998 FAERS cases (Δ 7,824 heavier vs apremilast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 134,536 FAERS cases (Δ 8,638 lighter vs apremilast); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 134,198 FAERS cases (Δ 8,976 lighter vs apremilast); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 58.3 pp vs apremilast's DEATH-MARKED): CASELOAD · HOSP-MID.
apremilast sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.