HIGH-VOLUME · FEMALE-LED
leflunomide Side Effects
leflunomide (also sold as Arava) is HIGH-VOLUME in this FAERS book #77 of 524 by FAERS report count. Signature opener: FEMALE-LED - 82% of sex-coded reports are female (74,653 F / 16,529 M).
Data updated 2026-05-15
- 102,095
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
leflunomide reporting skew - 82% of sex-coded reports are female (74,653 F / 16,529 M). Volume band HIGH-VOLUME #77 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for leflunomide (Arava): 102,095 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 24,923 of 102,095 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (82% of sex-coded rows)
Age peak 45-64 (29,335 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (8,456 reports, 8.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 2,231 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,196 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,146 |
| GLOSSODYNIA | 2,120 |
| TYPE 2 DIABETES MELLITUS | 2,093 |
| RASH | 2,072 |
| JOINT SWELLING | 2,064 |
| HAND DEFORMITY | 2,063 |
| FATIGUE | 2,058 |
| PSORIATIC ARTHROPATHY | 2,051 |
| SYNOVITIS | 2,040 |
| DUODENAL ULCER PERFORATION | 2,017 |
| HYPOAESTHESIA | 2,017 |
| FIBROMYALGIA | 2,013 |
| INFUSION RELATED REACTION | 1,993 |
| HEPATIC ENZYME INCREASED | 1,990 |
| HYPERTENSION | 1,985 |
| SWELLING | 1,983 |
| HELICOBACTER INFECTION | 1,976 |
Reactions in Hospitalization Reports
Hospitalization mid-share (27,652, 27.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 6,005 |
| PAIN | 5,662 |
| ARTHRALGIA | 5,457 |
| FATIGUE | 4,987 |
| RASH | 4,745 |
| JOINT SWELLING | 4,576 |
| ARTHROPATHY | 4,339 |
| DRUG HYPERSENSITIVITY | 4,027 |
| SYNOVITIS | 3,959 |
| CONDITION AGGRAVATED | 3,941 |
| NAUSEA | 3,826 |
| ABDOMINAL DISCOMFORT | 3,823 |
| DIARRHOEA | 3,729 |
| HEADACHE | 3,715 |
| HYPERSENSITIVITY | 3,657 |
| INFUSION RELATED REACTION | 3,604 |
| VOMITING | 3,534 |
How to read leflunomide FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 102,095 voluntary reports linked to leflunomide (Arava), 2004-2025. Death is listed on 8,456 (8.3%). Hospitalization appears on 27,652 (27.1%). 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 leflunomide
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 102,306 FAERS cases (Δ 211 heavier vs leflunomide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 103,354 FAERS cases (Δ 1,259 heavier vs leflunomide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 103,356 FAERS cases (Δ 1,261 heavier vs leflunomide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 104,378 FAERS cases (Δ 2,283 heavier vs leflunomide); DEATH-MARKED · HOSP-MID · 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 53.8 pp vs leflunomide's DEATH-HEAVY): CASELOAD · HOSP-MID.
leflunomide 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.