infliximab Side Effects
Also known as: Remicade
Analysis of 211,136 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
211,136
Death-Related
12,983
6.1% of reports
Hospitalizations
62,267
29.5% of reports
Top Indication
Rheumatoid Arthritis
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 12,983 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 2,839 |
| 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 |
| DRUG INEFFECTIVE | 1,959 |
| 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
Top reactions in 62,267 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 10,372 |
| DRUG INEFFECTIVE | 8,981 |
| 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 |
| PRODUCT USE ISSUE | 3,780 |
Nearby — Related Medications
What the FAERS Data Reveals About infliximab Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 211,136 voluntary reports linked to infliximab and its brand equivalents (Remicade), spanning 2002 through 2025. Of those, 12,983 (6.1%) listed death as an outcome and 62,267 (29.5%) involved hospitalization. The most common indication reported alongside adverse events was Rheumatoid Arthritis.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 63% were female and 37% male; age distribution skews toward 18-44, with 42,296 reports in that bracket. The single most reported reaction is drug ineffective with 38,908 submissions, followed by off label use and infusion related reaction.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.