HIGH-VOLUME · FEMALE-LED
etanercept Side Effects
etanercept (also sold as Enbrel) is HIGH-VOLUME in this FAERS book #2 of 524 by FAERS report count. Signature opener: FEMALE-LED - 75% of sex-coded reports are female (407,745 F / 139,055 M).
Data updated 2026-05-15
- 591,578
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
etanercept reporting skew - 75% of sex-coded reports are female (407,745 F / 139,055 M). Volume band HIGH-VOLUME #2 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for etanercept (Enbrel): 591,578 FAERS rows (2004-2025). Top named reactions: INJECTION SITE PAIN, RHEUMATOID ARTHRITIS, ARTHRALGIA. Outcome stamps DEATH-MARKED · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
INJECTION SITE PAIN leads 56,664 of 591,578 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (75% of sex-coded rows)
Age peak 45-64 (205,107 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 16,504 reports (2.8% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 6,230 |
| FATIGUE | 2,250 |
| RHEUMATOID ARTHRITIS | 2,104 |
| JOINT SWELLING | 2,030 |
| ARTHRALGIA | 2,003 |
| PAIN | 1,998 |
| RASH | 1,975 |
| HYPERTENSION | 1,973 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,935 |
| INFUSION RELATED REACTION | 1,928 |
| HEPATIC ENZYME INCREASED | 1,903 |
| HEADACHE | 1,879 |
| GLOSSODYNIA | 1,869 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,867 |
| HAND DEFORMITY | 1,856 |
| DIARRHOEA | 1,836 |
| PNEUMONIA | 1,819 |
| TYPE 2 DIABETES MELLITUS | 1,818 |
| VOMITING | 1,811 |
Reactions in Hospitalization Reports
Hospitalization mid-share (65,552, 11.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 8,061 |
| ARTHRALGIA | 7,585 |
| PAIN | 7,345 |
| PNEUMONIA | 5,567 |
| FATIGUE | 5,526 |
| CONDITION AGGRAVATED | 5,316 |
| JOINT SWELLING | 5,191 |
| ARTHROPATHY | 4,798 |
| RASH | 4,702 |
| NAUSEA | 4,305 |
| INFECTION | 4,275 |
| HEADACHE | 4,133 |
| MALAISE | 4,057 |
| DYSPNOEA | 4,028 |
| PYREXIA | 4,016 |
| SYNOVITIS | 3,999 |
| PAIN IN EXTREMITY | 3,991 |
| HYPERSENSITIVITY | 3,974 |
How to read etanercept FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-MID)
FAERS holds 591,578 voluntary reports linked to etanercept (Enbrel), 2004-2025. Death is listed on 16,504 (2.8%). Hospitalization appears on 65,552 (11.1%). Top co-reported indication: Rheumatoid Arthritis.
MEGA-CASE books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with etanercept
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 518,554 FAERS cases (Δ 73,024 lighter vs etanercept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 695,825 FAERS cases (Δ 104,247 heavier vs etanercept); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 482,856 FAERS cases (Δ 108,722 lighter vs etanercept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 417,458 FAERS cases (Δ 174,120 lighter vs etanercept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.3 pp vs etanercept's DEATH-MARKED): CASELOAD · HOSP-MID.
etanercept sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.