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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-QBTX: 289 Adverse Event Reports & Safety Profile

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289
Total FAERS Reports
13 (4.5%)
Deaths Reported
68
Hospitalizations
289
As Primary/Secondary Suspect
7
Life-Threatening
Prescription
Status

FDA Application: 761072 ·

First Report: 20170324 · Latest Report: 20250924

What Are the Most Common INFLIXIMAB-QBTX Side Effects?

#1 Most Reported
Off label use
123 reports (42.6%)
#2 Most Reported
Condition aggravated
57 reports (19.7%)
#3 Most Reported
Arthralgia
28 reports (9.7%)

All INFLIXIMAB-QBTX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 123 42.6% 5 32
Condition aggravated 57 19.7% 0 18
Arthralgia 28 9.7% 0 6
Intentional product use issue 25 8.7% 0 9
Uveitis 20 6.9% 0 2
Nausea 15 5.2% 1 11
Drug ineffective 13 4.5% 2 4
Nephrolithiasis 12 4.2% 0 4
Fatigue 11 3.8% 1 4
Fistula 10 3.5% 0 2
Malaise 10 3.5% 1 5
Pain 10 3.5% 0 3
Diarrhoea 9 3.1% 0 4
Back pain 8 2.8% 0 3
Cough 8 2.8% 0 1
Dyspnoea 8 2.8% 0 2
Headache 8 2.8% 0 2
Pyoderma gangrenosum 8 2.8% 0 0
Weight decreased 8 2.8% 0 1
Chest pain 7 2.4% 0 4

Who Reports INFLIXIMAB-QBTX Side Effects? Age & Gender Data

Gender: 58.4% female, 41.6% male. Average age: 48.7 years. Most reports from: CA. View detailed demographics →

Is INFLIXIMAB-QBTX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 1 0 1
2022 6 0 1
2023 13 0 1
2024 12 0 4
2025 182 4 51

View full timeline →

What Is INFLIXIMAB-QBTX Used For?

IndicationReports
Crohn's disease 120
Colitis ulcerative 74
Ankylosing spondylitis 27
Rheumatoid arthritis 17
Psoriatic arthropathy 10

INFLIXIMAB-QBTX vs Alternatives: Which Is Safer?

INFLIXIMAB-QBTX vs INFLIXIMAB, RECOMBINANT INFLIXIMAB-QBTX vs INFLUENZA VIRUS VACCINE INFLIXIMAB-QBTX vs INSULIN DEGLUDEC INFLIXIMAB-QBTX vs INSULIN GLARGINE INFLIXIMAB-QBTX vs INSULIN GLARGINE\LIXISENATIDE INFLIXIMAB-QBTX vs INSULIN HUMAN INFLIXIMAB-QBTX vs INSULIN LISPRO INFLIXIMAB-QBTX vs INSULIN NOS INFLIXIMAB-QBTX vs INTERFERON INFLIXIMAB-QBTX vs INTERFERON ALFA-2A OR INTERFERON ALFA-2B

Official FDA Label for INFLIXIMAB-QBTX

Official prescribing information from the FDA-approved drug label.