HIGH-VOLUME · FEMALE-LED
golimumab Side Effects
golimumab (also sold as Simponi) is HIGH-VOLUME in this FAERS book #92 of 524 by FAERS report count. Signature opener: FEMALE-LED - 77% of sex-coded reports are female (55,570 F / 16,936 M).
Data updated 2026-05-15
- 82,622
- FAERS reports
FAERS voluntary reports, 2006 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
golimumab reporting skew - 77% of sex-coded reports are female (55,570 F / 16,936 M). Volume band HIGH-VOLUME #92 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for golimumab (Simponi): 82,622 FAERS rows (2006-2025). Top named reactions: RHEUMATOID ARTHRITIS, PAIN, FATIGUE. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2006–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
RHEUMATOID ARTHRITIS leads 14,100 of 82,622 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (77% of sex-coded rows)
Age peak 45-64 (20,890 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (5,919 reports, 7.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| GLOSSODYNIA | 1,922 |
| WOUND | 1,909 |
| RASH | 1,889 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,889 |
| TYPE 2 DIABETES MELLITUS | 1,882 |
| HAND DEFORMITY | 1,878 |
| JOINT SWELLING | 1,876 |
| SYNOVITIS | 1,875 |
| RHEUMATOID ARTHRITIS | 1,866 |
| INFUSION RELATED REACTION | 1,864 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,853 |
| FATIGUE | 1,820 |
| PSORIATIC ARTHROPATHY | 1,797 |
| SWELLING | 1,793 |
| HEPATIC ENZYME INCREASED | 1,788 |
| HYPERTENSION | 1,780 |
| FIBROMYALGIA | 1,777 |
| HYPOAESTHESIA | 1,773 |
| PAIN | 1,735 |
Reactions in Hospitalization Reports
Hospitalization mid-share (19,695, 23.8%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 3,963 |
| ARTHRALGIA | 3,579 |
| PAIN | 3,569 |
| JOINT SWELLING | 3,363 |
| FATIGUE | 3,259 |
| RASH | 3,210 |
| SYNOVITIS | 3,089 |
| HYPERSENSITIVITY | 2,988 |
| PNEUMONIA | 2,945 |
| ARTHROPATHY | 2,920 |
| ALOPECIA | 2,858 |
| SWELLING | 2,815 |
| ABDOMINAL DISCOMFORT | 2,805 |
| INFECTION | 2,803 |
| INFUSION RELATED REACTION | 2,791 |
| CONDITION AGGRAVATED | 2,764 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,724 |
How to read golimumab FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 82,622 voluntary reports linked to golimumab (Simponi), 2006-2025. Death is listed on 5,919 (7.2%). Hospitalization appears on 19,695 (23.8%). Top co-reported indication: Rheumatoid Arthritis.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with golimumab
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 82,165 FAERS cases (Δ 457 lighter vs golimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 83,476 FAERS cases (Δ 854 heavier vs golimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 83,781 FAERS cases (Δ 1,159 heavier vs golimumab); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 84,725 FAERS cases (Δ 2,103 heavier vs golimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.9 pp vs golimumab's DEATH-HEAVY): CASELOAD · HOSP-MID.
golimumab stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.