HIGH-VOLUME · HOSP-MID
infliximab Side Effects
infliximab (also sold as Remicade) is HIGH-VOLUME in this FAERS book #25 of 524 by FAERS report count. Signature opener: HOSP-MID - 29.5% mention hospitalization (62,267 reports).
Data updated 2026-05-15
- 211,136
- FAERS reports
FAERS voluntary reports, 2002 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
infliximab: 29.5% mention hospitalization (62,267 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #25 of 524 by FAERS report count.
High-report extract for infliximab (Remicade): 211,136 FAERS rows (2002-2025). Top named reactions: INFUSION RELATED REACTION, CONDITION AGGRAVATED, RHEUMATOID ARTHRITIS. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2002–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
INFUSION RELATED REACTION leads 18,648 of 211,136 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (42,296 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (12,983 reports, 6.1%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 2,334 |
| JOINT SWELLING | 2,149 |
| INFUSION RELATED REACTION | 2,141 |
| FATIGUE | 2,109 |
| RHEUMATOID ARTHRITIS | 2,104 |
| HYPERTENSION | 2,102 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,067 |
| GLOSSODYNIA | 2,042 |
| HEPATIC ENZYME INCREASED | 2,038 |
| RASH | 2,031 |
| PAIN | 1,995 |
| HAND DEFORMITY | 1,960 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,945 |
| SYNOVITIS | 1,922 |
| TYPE 2 DIABETES MELLITUS | 1,908 |
| WOUND | 1,900 |
| FIBROMYALGIA | 1,898 |
| HYPOAESTHESIA | 1,860 |
Reactions in Hospitalization Reports
Hospitalization mid-share (62,267, 29.5%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| CONDITION AGGRAVATED | 6,209 |
| INFUSION RELATED REACTION | 5,806 |
| ARTHRALGIA | 5,666 |
| PAIN | 5,511 |
| FATIGUE | 5,020 |
| RHEUMATOID ARTHRITIS | 4,834 |
| NAUSEA | 4,762 |
| PYREXIA | 4,712 |
| DIARRHOEA | 4,699 |
| VOMITING | 4,503 |
| RASH | 4,458 |
| MALAISE | 4,076 |
| HEADACHE | 4,057 |
| JOINT SWELLING | 4,009 |
| DYSPNOEA | 3,958 |
| PNEUMONIA | 3,935 |
| CROHN^S DISEASE | 3,925 |
How to read infliximab FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-MID)
FAERS holds 211,136 voluntary reports linked to infliximab (Remicade), 2002-2025. Death is listed on 12,983 (6.1%). Hospitalization appears on 62,267 (29.5%). Top co-reported indication: Rheumatoid Arthritis.
MEGA-CASE books overweight common drugs and loud reporting cultures; HOSP-MID is the page opener, not a per-patient risk.
Read with infliximab
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 203,269 FAERS cases (Δ 7,867 lighter vs infliximab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 200,719 FAERS cases (Δ 10,417 lighter vs infliximab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 197,405 FAERS cases (Δ 13,731 lighter vs infliximab); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 197,074 FAERS cases (Δ 14,062 lighter vs infliximab); DEATH-RARE · HOSP-LIGHT · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.0 pp vs infliximab's DEATH-HEAVY): CASELOAD · HOSP-MID.
infliximab 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.