Drug side effects
infliximab Side Effects
The reactions most often reported to the FDA for infliximab (also sold as Remicade), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 211,136
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2002 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of infliximab come from 211,136 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 211,136 reports to the FDA Adverse Event Reporting System (FAERS) for infliximab (Remicade): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
211,136
Reports Mentioning Death
12,983
6.1% of reports — not proof the medicine caused the death
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 |
|---|---|
| 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
Top reactions in 62,267 reports where hospitalization was an outcome.
| 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 |
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 infusion related reaction with 18,648 submissions, followed by condition aggravated and rheumatoid arthritis.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to infliximab's 211,136.
Read our methodology - how this data is sourced, computed, and verified.