HIGH-VOLUME · FEMALE-LED
abatacept Side Effects
abatacept (also sold as Orencia) is HIGH-VOLUME in this FAERS book #51 of 524 by FAERS report count. Signature opener: FEMALE-LED - 85% of sex-coded reports are female (102,151 F / 17,902 M).
Data updated 2026-05-15
- 133,227
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
abatacept reporting skew - 85% of sex-coded reports are female (102,151 F / 17,902 M). Volume band HIGH-VOLUME #51 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for abatacept (Orencia): 133,227 FAERS rows (2004-2025). Top named reactions: RHEUMATOID ARTHRITIS, PAIN, ARTHRALGIA. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
RHEUMATOID ARTHRITIS leads 23,596 of 133,227 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (85% of sex-coded rows)
Age peak 45-64 (37,860 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (8,659 reports, 6.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 3,005 |
| JOINT SWELLING | 2,016 |
| RHEUMATOID ARTHRITIS | 2,013 |
| INFUSION RELATED REACTION | 1,966 |
| PAIN | 1,954 |
| RASH | 1,943 |
| FATIGUE | 1,892 |
| HYPERTENSION | 1,886 |
| GLOSSODYNIA | 1,883 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,857 |
| TYPE 2 DIABETES MELLITUS | 1,857 |
| HEPATIC ENZYME INCREASED | 1,853 |
| SYNOVITIS | 1,832 |
| WOUND | 1,824 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,820 |
| HAND DEFORMITY | 1,814 |
| FIBROMYALGIA | 1,813 |
| PSORIATIC ARTHROPATHY | 1,785 |
| HYPOAESTHESIA | 1,776 |
Reactions in Hospitalization Reports
Hospitalization mid-share (24,589, 18.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 5,521 |
| PAIN | 4,980 |
| ARTHRALGIA | 4,253 |
| ARTHROPATHY | 4,191 |
| FATIGUE | 4,089 |
| RASH | 4,069 |
| SYNOVITIS | 3,911 |
| JOINT SWELLING | 3,897 |
| HYPERSENSITIVITY | 3,446 |
| DRUG HYPERSENSITIVITY | 3,391 |
| CONDITION AGGRAVATED | 3,328 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 3,293 |
| INFECTION | 3,189 |
| NAUSEA | 3,172 |
| PERIPHERAL SWELLING | 3,114 |
| INFUSION RELATED REACTION | 3,080 |
| DIARRHOEA | 3,018 |
How to read abatacept FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 133,227 voluntary reports linked to abatacept (Orencia), 2004-2025. Death is listed on 8,659 (6.5%). Hospitalization appears on 24,589 (18.5%). 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 abatacept
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 133,513 FAERS cases (Δ 286 heavier vs abatacept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 133,996 FAERS cases (Δ 769 heavier vs abatacept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 134,198 FAERS cases (Δ 971 heavier vs abatacept); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 134,536 FAERS cases (Δ 1,309 heavier vs abatacept); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.6 pp vs abatacept's DEATH-HEAVY): CASELOAD · HOSP-MID.
abatacept stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.