Remicade

N/A

Manufactured by Janssen Biotech, Inc.

781,021 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Remicade

Remicade is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. The most commonly reported adverse reactions for Remicade include DRUG INEFFECTIVE, OFF LABEL USE, CONDITION AGGRAVATED, INFUSION RELATED REACTION, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Remicade.

Top Adverse Reactions

DRUG INEFFECTIVE39,146 reports
OFF LABEL USE37,606 reports
CONDITION AGGRAVATED19,094 reports
INFUSION RELATED REACTION18,780 reports
RHEUMATOID ARTHRITIS18,263 reports
PAIN18,243 reports
ARTHRALGIA17,204 reports
FATIGUE16,275 reports
RASH13,033 reports
PRODUCT USE ISSUE12,953 reports
INTENTIONAL PRODUCT USE ISSUE12,342 reports
DRUG INTOLERANCE12,282 reports
NAUSEA11,928 reports
ALOPECIA11,692 reports
JOINT SWELLING11,421 reports
HEADACHE10,879 reports
SYSTEMIC LUPUS ERYTHEMATOSUS10,545 reports
ABDOMINAL DISCOMFORT10,525 reports
DIARRHOEA10,390 reports
DYSPNOEA10,271 reports
HYPERSENSITIVITY10,100 reports
CONTRAINDICATED PRODUCT ADMINISTERED9,955 reports
MALAISE9,767 reports
ARTHROPATHY9,591 reports
TREATMENT FAILURE9,377 reports
CROHN^S DISEASE9,180 reports
DRUG HYPERSENSITIVITY9,166 reports
PYREXIA9,165 reports
WEIGHT INCREASED8,951 reports
SYNOVITIS8,841 reports
SWELLING8,735 reports
VOMITING8,675 reports
PEMPHIGUS8,656 reports
GLOSSODYNIA8,182 reports
PNEUMONIA8,010 reports
HEPATIC ENZYME INCREASED7,792 reports
ABDOMINAL PAIN7,725 reports
HYPERTENSION7,493 reports
INFECTION7,461 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION7,457 reports
HAND DEFORMITY7,346 reports
WEIGHT DECREASED7,204 reports
THERAPEUTIC PRODUCT EFFECT DECREASED7,186 reports
WOUND7,051 reports
PRURITUS6,895 reports
MATERNAL EXPOSURE DURING PREGNANCY6,726 reports
NASOPHARYNGITIS6,647 reports
PERIPHERAL SWELLING6,499 reports
GENERAL PHYSICAL HEALTH DETERIORATION6,289 reports
MUSCULOSKELETAL STIFFNESS6,260 reports
PERICARDITIS6,129 reports
DISCOMFORT5,963 reports
DIZZINESS5,896 reports
COLITIS ULCERATIVE5,871 reports
PAIN IN EXTREMITY5,836 reports
URTICARIA5,711 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE5,577 reports
PSORIATIC ARTHROPATHY5,370 reports
ASTHENIA5,174 reports
SINUSITIS4,993 reports
PRODUCT USE IN UNAPPROVED INDICATION4,950 reports
PSORIASIS4,817 reports
HELICOBACTER INFECTION4,727 reports
DUODENAL ULCER PERFORATION4,547 reports
MOBILITY DECREASED4,543 reports
GASTROINTESTINAL DISORDER4,501 reports
STOMATITIS4,384 reports
C REACTIVE PROTEIN INCREASED4,308 reports
BLISTER4,270 reports
CONFUSIONAL STATE4,267 reports
LOWER RESPIRATORY TRACT INFECTION4,263 reports
IMPAIRED HEALING4,261 reports
INFLAMMATION4,248 reports
CHEST PAIN4,189 reports
HYPOAESTHESIA4,175 reports
COVID 194,144 reports
ARTHRITIS4,135 reports
EXPOSURE DURING PREGNANCY4,134 reports
HAEMATOCHEZIA4,075 reports
ABDOMINAL PAIN UPPER4,067 reports
RHEUMATOID FACTOR POSITIVE4,030 reports
FOLLICULITIS3,970 reports
ERYTHEMA3,937 reports
IRRITABLE BOWEL SYNDROME3,899 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE3,863 reports
DECREASED APPETITE3,796 reports
BLOOD PRESSURE INCREASED3,791 reports
BLOOD CHOLESTEROL INCREASED3,693 reports
BACK PAIN3,633 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES3,617 reports
COUGH3,607 reports
FIBROMYALGIA3,546 reports
INSOMNIA3,503 reports
TYPE 2 DIABETES MELLITUS3,477 reports
DEPRESSION3,411 reports
ILL DEFINED DISORDER3,401 reports
GAIT DISTURBANCE3,292 reports
LUPUS LIKE SYNDROME3,276 reports
MUSCLE INJURY3,267 reports
ADVERSE EVENT3,233 reports

Report Outcomes

Out of 212,244 classified reports for Remicade:

  • Serious: 187,771 reports (88.5%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 24,473 reports (11.5%)
Serious 88.5%Non-Serious 11.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female116,659 (63.1%)
Male67,589 (36.5%)
Unknown754 (0.4%)

Reports by Age

Age 433,698 reports
Age 443,626 reports
Age 402,669 reports
Age 532,504 reports
Age 602,504 reports
Age 592,478 reports
Age 542,263 reports
Age 162,258 reports
Age 582,251 reports
Age 172,239 reports
Age 562,209 reports
Age 452,108 reports
Age 572,093 reports
Age 632,033 reports
Age 502,009 reports
Age 511,993 reports
Age 521,968 reports
Age 651,962 reports
Age 551,960 reports
Age 621,901 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Remicade?

This profile reflects 781,021 FDA FAERS reports that mention Remicade. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Remicade?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, CONDITION AGGRAVATED, INFUSION RELATED REACTION, RHEUMATOID ARTHRITIS, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Remicade?

Labeling and FAERS entries often list Janssen Biotech, Inc. in connection with Remicade. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Janssen Biotech, Inc.

Explore other medications manufactured by Janssen Biotech, Inc. and compare their safety profiles:

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with Remicade:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)ABEMACICLIB (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)

View all drugs reporting DRUG INEFFECTIVE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsJanssen Biotech, Inc. PortfolioDRUG INEFFECTIVE in Other DrugsOFF LABEL USE in Other DrugsCONDITION AGGRAVATED in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.