HIGH-VOLUME · SEX-BALANCED
adalimumab Side Effects
adalimumab (also sold as Humira) is HIGH-VOLUME in this FAERS book #1 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 68% of sex-coded reports are female (446,643 F / 209,782 M).
Data updated 2026-05-15
- 695,825
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
adalimumab reporting skew - 68% of sex-coded reports are female (446,643 F / 209,782 M). Volume band HIGH-VOLUME #1 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for adalimumab (Humira): 695,825 FAERS rows (2004-2025). Top named reactions: PAIN, ARTHRALGIA, INJECTION SITE PAIN. Outcome stamps DEATH-MARKED · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
PAIN leads 49,062 of 695,825 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (160,251 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 28,962 reports (4.2% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 11,907 |
| PNEUMONIA | 2,626 |
| FATIGUE | 2,586 |
| RHEUMATOID ARTHRITIS | 2,547 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,440 |
| HYPERTENSION | 2,402 |
| PAIN | 2,389 |
| ARTHRALGIA | 2,303 |
| JOINT SWELLING | 2,292 |
| MALAISE | 2,285 |
| DIARRHOEA | 2,245 |
| INFUSION RELATED REACTION | 2,234 |
| RASH | 2,228 |
| VOMITING | 2,224 |
| HEADACHE | 2,212 |
| HYPOAESTHESIA | 2,194 |
| GLOSSODYNIA | 2,176 |
| DYSPNOEA | 2,171 |
| HEPATIC ENZYME INCREASED | 2,163 |
Reactions in Hospitalization Reports
Hospitalization mid-share (146,638, 21.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PAIN | 12,371 |
| ARTHRALGIA | 11,485 |
| DIARRHOEA | 9,534 |
| CROHN^S DISEASE | 9,448 |
| FATIGUE | 9,183 |
| PNEUMONIA | 8,880 |
| PYREXIA | 8,750 |
| NAUSEA | 8,539 |
| VOMITING | 8,458 |
| RHEUMATOID ARTHRITIS | 8,161 |
| MALAISE | 8,066 |
| ABDOMINAL PAIN | 7,488 |
| FALL | 7,057 |
| DYSPNOEA | 6,942 |
| HEADACHE | 6,931 |
| ASTHENIA | 6,421 |
| WEIGHT DECREASED | 6,403 |
| JOINT SWELLING | 6,218 |
How to read adalimumab FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-MID)
FAERS holds 695,825 voluntary reports linked to adalimumab (Humira), 2004-2025. Death is listed on 28,962 (4.2%). Hospitalization appears on 146,638 (21.1%). Top co-reported indication: Rheumatoid Arthritis.
MEGA-CASE books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with adalimumab
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 591,578 FAERS cases (Δ 104,247 lighter vs adalimumab); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 518,554 FAERS cases (Δ 177,271 lighter vs adalimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 482,856 FAERS cases (Δ 212,969 lighter vs adalimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 417,458 FAERS cases (Δ 278,367 lighter vs adalimumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.9 pp vs adalimumab's DEATH-MARKED): CASELOAD · HOSP-MID.
adalimumab sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.