MID-VOLUME · FEMALE-LED
sarilumab Side Effects
sarilumab (also sold as Kevzara) sits MID-VOLUME #217 of 524 by FAERS report count. Lead signal: FEMALE-LED - 84% of sex-coded reports are female (17,963 F / 3,459 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 23,683
- FAERS reports
FDA Adverse Event Reporting System extract for sarilumab. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
sarilumab reporting skew - 84% of sex-coded reports are female (17,963 F / 3,459 M). Volume band MID-VOLUME #217 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for sarilumab (Kevzara) (23,683 reports). Signature FEMALE-LED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2015–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
PAIN leads 5,313 of 23,683 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (84% of sex-coded rows)
Age peak 45-64 (7,520 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (2,313 reports, 9.8%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,016 |
| DUODENAL ULCER PERFORATION | 1,014 |
| ABDOMINAL DISCOMFORT | 994 |
| PEMPHIGUS | 978 |
| TYPE 2 DIABETES MELLITUS | 975 |
| PERICARDITIS | 971 |
| RHEUMATOID ARTHRITIS | 966 |
| ALOPECIA | 950 |
| HAND DEFORMITY | 943 |
| BLOOD CHOLESTEROL INCREASED | 938 |
| ARTHRALGIA | 937 |
| GLOSSODYNIA | 929 |
| PSORIATIC ARTHROPATHY | 928 |
| HELICOBACTER INFECTION | 927 |
| HEPATIC ENZYME INCREASED | 914 |
| ARTHROPATHY | 913 |
| BLISTER | 910 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 909 |
| HYPERTENSION | 907 |
Reactions in Hospitalization Reports
Hospitalization mid-share (4,047, 17.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 1,464 |
| ABDOMINAL DISCOMFORT | 1,402 |
| ALOPECIA | 1,321 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,319 |
| ARTHRALGIA | 1,297 |
| HEPATIC ENZYME INCREASED | 1,293 |
| DUODENAL ULCER PERFORATION | 1,288 |
| FATIGUE | 1,263 |
| PERICARDITIS | 1,263 |
| HELICOBACTER INFECTION | 1,256 |
| PAIN | 1,249 |
| PEMPHIGUS | 1,242 |
| ARTHROPATHY | 1,240 |
| BLISTER | 1,221 |
| HAND DEFORMITY | 1,213 |
| RASH | 1,199 |
| GLOSSODYNIA | 1,198 |
| JOINT SWELLING | 1,191 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,165 |
| SWELLING | 1,162 |
How to read sarilumab FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 23,683 voluntary reports linked to sarilumab (Kevzara), 2015-2025. Death is listed on 2,313 (9.8%). Hospitalization appears on 4,047 (17.1%). Top co-reported indication: Rheumatoid Arthritis.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 84% of sex-coded reports are female (17,963 F / 3,459 M).
Read with sarilumab
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 23,495 FAERS cases (Δ 188 lighter vs sarilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 23,902 FAERS cases (Δ 219 heavier vs sarilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 24,014 FAERS cases (Δ 331 heavier vs sarilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 23,287 FAERS cases (Δ 396 lighter vs sarilumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.3 pp vs sarilumab's DEATH-HEAVY): CASELOAD · HOSP-MID.
sarilumab stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.