HIGH-VOLUME · FEMALE-LED
tofacitinib Side Effects
tofacitinib (also sold as Xeljanz) is HIGH-VOLUME in this FAERS book #34 of 524 by FAERS report count. Signature opener: FEMALE-LED - 80% of sex-coded reports are female (138,558 F / 33,777 M).
Data updated 2026-05-15
- 181,998
- FAERS reports
FAERS voluntary reports, 2008 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
tofacitinib reporting skew - 80% of sex-coded reports are female (138,558 F / 33,777 M). Volume band HIGH-VOLUME #34 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for tofacitinib (Xeljanz): 181,998 FAERS rows (2008-2025). Top named reactions: PAIN, ARTHRALGIA, CONDITION AGGRAVATED. Outcome stamps DEATH-MARKED · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2008–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
PAIN leads 25,737 of 181,998 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (80% of sex-coded rows)
Age peak 45-64 (69,765 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 8,655 reports (4.8% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 3,491 |
| JOINT SWELLING | 1,969 |
| RHEUMATOID ARTHRITIS | 1,950 |
| PAIN | 1,933 |
| RASH | 1,899 |
| INFUSION RELATED REACTION | 1,889 |
| FATIGUE | 1,860 |
| SYNOVITIS | 1,848 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,844 |
| GLOSSODYNIA | 1,840 |
| TYPE 2 DIABETES MELLITUS | 1,836 |
| WOUND | 1,826 |
| HEPATIC ENZYME INCREASED | 1,796 |
| HYPERTENSION | 1,796 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,768 |
| HAND DEFORMITY | 1,768 |
| PSORIATIC ARTHROPATHY | 1,732 |
| HYPOAESTHESIA | 1,729 |
| SWELLING | 1,719 |
Reactions in Hospitalization Reports
Hospitalization mid-share (24,557, 13.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PAIN | 5,294 |
| RHEUMATOID ARTHRITIS | 4,484 |
| CONDITION AGGRAVATED | 4,373 |
| ARTHRALGIA | 4,344 |
| FATIGUE | 4,196 |
| RASH | 3,865 |
| JOINT SWELLING | 3,732 |
| ARTHROPATHY | 3,429 |
| SYNOVITIS | 3,310 |
| PERIPHERAL SWELLING | 3,152 |
| PNEUMONIA | 3,053 |
| MALAISE | 3,046 |
| DRUG HYPERSENSITIVITY | 3,037 |
| HYPERSENSITIVITY | 3,027 |
| ABDOMINAL DISCOMFORT | 2,985 |
| INFECTION | 2,974 |
| HEADACHE | 2,923 |
How to read tofacitinib FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-MID)
FAERS holds 181,998 voluntary reports linked to tofacitinib (Xeljanz), 2008-2025. Death is listed on 8,655 (4.8%). Hospitalization appears on 24,557 (13.5%). 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 tofacitinib
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 180,422 FAERS cases (Δ 1,576 lighter vs tofacitinib); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 185,533 FAERS cases (Δ 3,535 heavier vs tofacitinib); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 178,147 FAERS cases (Δ 3,851 lighter vs tofacitinib); DEATH-RARE · HOSP-LIGHT · FEMALE-LED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 174,469 FAERS cases (Δ 7,529 lighter vs tofacitinib); 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 57.4 pp vs tofacitinib's DEATH-MARKED): CASELOAD · HOSP-MID.
tofacitinib sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.