HIGH-VOLUME · FEMALE-LED
methotrexate Side Effects
methotrexate (also sold as Trexall, Otrexup) is HIGH-VOLUME in this FAERS book #7 of 524 by FAERS report count. Signature opener: FEMALE-LED - 71% of sex-coded reports are female (259,708 F / 107,132 M).
Data updated 2026-05-15
- 410,053
- FAERS reports
FAERS voluntary reports, 1999 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
methotrexate reporting skew - 71% of sex-coded reports are female (259,708 F / 107,132 M). Volume band HIGH-VOLUME #7 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for methotrexate (Trexall): 410,053 FAERS rows (1999-2025). Top named reactions: RHEUMATOID ARTHRITIS, ARTHRALGIA, PAIN. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (1999–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
RHEUMATOID ARTHRITIS leads 38,053 of 410,053 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (71% of sex-coded rows)
Age peak 45-64 (105,081 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (32,502 reports, 7.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 4,939 |
| PNEUMONIA | 3,509 |
| SEPSIS | 2,515 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,444 |
| PYREXIA | 2,393 |
| DIARRHOEA | 2,379 |
| RHEUMATOID ARTHRITIS | 2,344 |
| INFECTION | 2,338 |
| VOMITING | 2,324 |
| RASH | 2,272 |
| FATIGUE | 2,247 |
| PAIN | 2,244 |
| HYPERTENSION | 2,159 |
| CONDITION AGGRAVATED | 2,094 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,084 |
| DYSPNOEA | 2,077 |
| TYPE 2 DIABETES MELLITUS | 2,044 |
Reactions in Hospitalization Reports
Hospitalization mid-share (115,535, 28.2%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| ARTHRALGIA | 9,790 |
| PAIN | 9,473 |
| PYREXIA | 9,136 |
| RHEUMATOID ARTHRITIS | 9,082 |
| PNEUMONIA | 8,949 |
| FATIGUE | 8,109 |
| NAUSEA | 8,009 |
| VOMITING | 7,344 |
| DIARRHOEA | 7,185 |
| HEADACHE | 6,745 |
| DYSPNOEA | 6,592 |
| CONDITION AGGRAVATED | 6,490 |
| RASH | 6,108 |
| MALAISE | 5,986 |
| JOINT SWELLING | 5,837 |
| INFECTION | 5,269 |
| PAIN IN EXTREMITY | 5,218 |
| FALL | 5,211 |
How to read methotrexate FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 410,053 voluntary reports linked to methotrexate (Trexall, Otrexup), 1999-2025. Death is listed on 32,502 (7.9%). Hospitalization appears on 115,535 (28.2%). 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 methotrexate
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 411,692 FAERS cases (Δ 1,639 heavier vs methotrexate); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 417,458 FAERS cases (Δ 7,405 heavier vs methotrexate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 387,984 FAERS cases (Δ 22,069 lighter vs methotrexate); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 366,491 FAERS cases (Δ 43,562 lighter vs methotrexate); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.2 pp vs methotrexate's DEATH-HEAVY): CASELOAD · HOSP-MID.
methotrexate 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.