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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-ABDA: 1,810 Adverse Event Reports & Safety Profile

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1,810
Total FAERS Reports
18 (1.0%)
Deaths Reported
452
Hospitalizations
1,810
As Primary/Secondary Suspect
51
Life-Threatening
21
Disabilities
Prescription
Status

FDA Application: 761054 ·

First Report: 20171201 · Latest Report: 20250918

What Are the Most Common INFLIXIMAB-ABDA Side Effects?

#1 Most Reported
Off label use
493 reports (27.2%)
#2 Most Reported
Product use issue
272 reports (15.0%)
#3 Most Reported
Dyspnoea
145 reports (8.0%)

All INFLIXIMAB-ABDA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 493 27.2% 6 178
Product use issue 272 15.0% 3 86
Dyspnoea 145 8.0% 0 44
Nausea 142 7.9% 1 34
Crohn's disease 133 7.4% 0 54
Arthralgia 131 7.2% 2 56
Diarrhoea 118 6.5% 4 49
Drug ineffective 111 6.1% 1 44
Headache 111 6.1% 2 32
Malaise 111 6.1% 3 50
Abdominal pain 107 5.9% 0 36
Fatigue 107 5.9% 3 32
Pruritus 107 5.9% 0 35
Vomiting 102 5.6% 1 35
Rash 101 5.6% 1 37
Chest discomfort 88 4.9% 0 18
Pain 88 4.9% 1 19
Colitis ulcerative 86 4.8% 0 15
Flushing 84 4.6% 0 8
Infusion related reaction 84 4.6% 1 18

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

Gender: 61.0% female, 39.0% male. Average age: 46.3 years. Most reports from: CA. View detailed demographics →

Is INFLIXIMAB-ABDA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 1 0 1
2018 19 0 3
2019 66 0 15
2020 98 2 22
2021 127 1 22
2022 100 1 18
2023 162 3 34
2024 262 4 83
2025 160 2 62

View full timeline →

What Is INFLIXIMAB-ABDA Used For?

IndicationReports
Crohn's disease 703
Colitis ulcerative 371
Product used for unknown indication 246
Rheumatoid arthritis 144
Ankylosing spondylitis 87
Psoriatic arthropathy 61
Hidradenitis 35
Sarcoidosis 28
Colitis 22
Behcet's syndrome 17

INFLIXIMAB-ABDA vs Alternatives: Which Is Safer?

INFLIXIMAB-ABDA vs INFLIXIMAB-AXXQ INFLIXIMAB-ABDA vs INFLIXIMAB-DYYB INFLIXIMAB-ABDA vs INFLIXIMAB-QBTX INFLIXIMAB-ABDA vs INFLIXIMAB, RECOMBINANT INFLIXIMAB-ABDA 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-ABDA vs INFLUENZA VIRUS VACCINE INFLIXIMAB-ABDA vs INFLUENZA VIRUS VACCINE QUADRIVALENT TYPE A+B INFLIXIMAB-ABDA vs INGENOL MEBUTATE INFLIXIMAB-ABDA vs INLYTA INFLIXIMAB-ABDA vs INOTERSEN

Official FDA Label for INFLIXIMAB-ABDA

Official prescribing information from the FDA-approved drug label.