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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

REMICADE: 3,195 Adverse Event Reports & Safety Profile

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3,195
Total FAERS Reports
129 (4.0%)
Deaths Reported
1,324
Hospitalizations
3,195
As Primary/Secondary Suspect
123
Life-Threatening
53
Disabilities

First Report: 1998 · Latest Report: 20140627

What Are the Most Common REMICADE Side Effects?

#1 Most Reported
Infusion related reaction
313 reports (9.8%)
#2 Most Reported
Crohn's disease
193 reports (6.0%)
#3 Most Reported
Drug ineffective
157 reports (4.9%)

All REMICADE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infusion related reaction 313 9.8% 5 79
Crohn's disease 193 6.0% 2 143
Drug ineffective 157 4.9% 4 67
Dyspnoea 141 4.4% 2 38
Exposure during pregnancy 96 3.0% 0 19
Arthralgia 95 3.0% 1 33
Nausea 85 2.7% 1 29
Pain 84 2.6% 0 33
Vomiting 81 2.5% 0 45
Malaise 80 2.5% 3 38
Pyrexia 77 2.4% 5 54
Off label use 75 2.4% 6 29
Diarrhoea 72 2.3% 1 40
Fistula 71 2.2% 1 19
Abdominal pain 70 2.2% 1 42
Headache 69 2.2% 2 29
Pneumonia 66 2.1% 7 48
Weight decreased 65 2.0% 2 32
Chest discomfort 63 2.0% 0 11
Fatigue 59 1.9% 3 17

Who Reports REMICADE Side Effects? Age & Gender Data

Average age: 42.9 years. Most reports from: CA. View detailed demographics →

Is REMICADE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 1
2001 3 2 1
2002 1 0 1
2003 3 1 3
2004 3 1 2
2005 7 1 4
2006 13 2 6
2007 17 4 8
2008 20 1 9
2009 39 2 14
2010 73 5 38
2011 92 6 57
2012 224 15 108
2013 1,011 31 484
2014 980 20 463

View full timeline →

What Is REMICADE Used For?

IndicationReports
Crohn's disease 1,383
Rheumatoid arthritis 523
Colitis ulcerative 433
Product used for unknown indication 240
Ankylosing spondylitis 199
Psoriatic arthropathy 168
Psoriasis 115
Inflammatory bowel disease 101
Colitis 29
Arthritis 21

REMICADE vs Alternatives: Which Is Safer?

REMICADE vs REMIFENTANIL REMICADE vs REMIMAZOLAM REMICADE vs REMODULIN REMICADE vs REPAGLINIDE REMICADE vs REPOTRECTINIB REMICADE vs REQUIP REMICADE vs RESLIZUMAB REMICADE vs RESMETIROM REMICADE vs RESTASIS REMICADE vs RETINOL

Official FDA Label for REMICADE

Official prescribing information from the FDA-approved drug label.