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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.

INFLIXIMAB, RECOMBINANT: 255 Adverse Event Reports & Safety Profile

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255
Total FAERS Reports
16 (6.3%)
Deaths Reported
93
Hospitalizations
255
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities

First Report: 200606 · Latest Report: 20140404

What Are the Most Common INFLIXIMAB, RECOMBINANT Side Effects?

#1 Most Reported
Pneumocystis jirovecii pneumonia
29 reports (11.4%)
#2 Most Reported
Off label use
21 reports (8.2%)
#3 Most Reported
Infusion related reaction
18 reports (7.1%)

All INFLIXIMAB, RECOMBINANT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pneumocystis jirovecii pneumonia 29 11.4% 1 22
Off label use 21 8.2% 2 6
Infusion related reaction 18 7.1% 0 5
Histoplasmosis disseminated 16 6.3% 0 12
Tuberculosis 15 5.9% 0 0
Lupus-like syndrome 13 5.1% 1 2
Pulmonary tuberculosis 12 4.7% 0 3
Drug ineffective 11 4.3% 0 2
Pneumonia 11 4.3% 1 7
Crohn's disease 9 3.5% 0 6
Disseminated tuberculosis 7 2.8% 0 2
Immune reconstitution inflammatory syndrome 7 2.8% 0 5
Infection 6 2.4% 3 1
Drug ineffective for unapproved indication 5 2.0% 1 1
Neoplasm malignant 5 2.0% 1 1
Psoriasis 5 2.0% 0 2
Rash 5 2.0% 0 1
Therapeutic response decreased 5 2.0% 0 0

Who Reports INFLIXIMAB, RECOMBINANT Side Effects? Age & Gender Data

Average age: 44.2 years. Most reports from: US. View detailed demographics →

Is INFLIXIMAB, RECOMBINANT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2007 2 0 0
2008 2 0 0
2009 2 0 1
2010 3 0 1
2011 7 0 6
2012 8 2 6
2013 13 0 9
2014 9 0 7

View full timeline →

What Is INFLIXIMAB, RECOMBINANT Used For?

IndicationReports
Crohn's disease 66
Rheumatoid arthritis 63
Psoriasis 23
Colitis ulcerative 21
Ankylosing spondylitis 20
Inflammatory bowel disease 13
Behcet's syndrome 12
Uveitis 11
Juvenile idiopathic arthritis 10
Product used for unknown indication 10

INFLIXIMAB, RECOMBINANT vs Alternatives: Which Is Safer?

INFLIXIMAB, RECOMBINANT vs INFLUENZA A VIRUS A/CALIFORNIA/7/2009 LIVE ANTIGEN\INFLUENZA A VIRUS A/TEXAS/50/2012 LIVE ANTIGEN\INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE ANTIGEN\INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 LIVE ANTIGEN INFLIXIMAB, RECOMBINANT vs INFLUENZA VIRUS VACCINE INFLIXIMAB, RECOMBINANT vs INFLUENZA VIRUS VACCINE QUADRIVALENT TYPE A+B INFLIXIMAB, RECOMBINANT vs INGENOL MEBUTATE INFLIXIMAB, RECOMBINANT vs INLYTA INFLIXIMAB, RECOMBINANT vs INOTERSEN INFLIXIMAB, RECOMBINANT vs INOTUZUMAB OZOGAMICIN INFLIXIMAB, RECOMBINANT vs INSULIN INFLIXIMAB, RECOMBINANT vs INSULIN ASPART INFLIXIMAB, RECOMBINANT vs INSULIN ASPART\INSULIN DEGLUDEC

Official FDA Label for INFLIXIMAB, RECOMBINANT

Official prescribing information from the FDA-approved drug label.