85/100 · Critical
Manufactured by Janssen Biotech, Inc.
High Seriousness of Adverse Reactions for Infliximab
769,608 FDA adverse event reports analyzed
Last updated: 2026-05-12
INFLIXIMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 769,608 FDA adverse event reports, INFLIXIMAB has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for INFLIXIMAB include DRUG INEFFECTIVE, OFF LABEL USE, INFUSION RELATED REACTION, CONDITION AGGRAVATED, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INFLIXIMAB.
Infliximab has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 769,608 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Infusion Related Reaction. Of classified reports, 88.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reactions are serious, with 88.3% of reports being serious events.
A wide range of reactions are reported, indicating diverse safety concerns. The most common reactions include infusion-related reactions and conditions aggravated by the drug.
Patients taking Infliximab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Infliximab can cause serious infusion-related reactions, and patients should be monitored closely during and after administration. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Infliximab received a safety concern score of 85/100 (high concern). This is based on a 88.3% serious event ratio across 211,106 classified reports. The score accounts for 769,608 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 116,761, Male: 67,689, Unknown: 754. The most frequently reported age groups are age 43 (3,596 reports), age 44 (3,522 reports), age 40 (2,619 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 211,106 classified reports for INFLIXIMAB:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Infliximab can cause serious infusion-related reactions, and patients should be monitored closely during and after administration.
If you are taking Infliximab, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, infusion related reaction, condition aggravated, rheumatoid arthritis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any adverse reactions to their healthcare provider immediately. Follow the prescribed treatment plan and do not alter the schedule without consulting a healthcare professional. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of infliximab and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 769,608 adverse event reports associated with Infliximab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Infliximab include Drug Ineffective, Off Label Use, Infusion Related Reaction, Condition Aggravated, Rheumatoid Arthritis. By volume, the top reported reactions are: Drug Ineffective (38,907 reports), Off Label Use (36,963 reports), Infusion Related Reaction (18,649 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Infliximab.
Out of 211,106 classified reports, 186,475 (88.3%) were classified as serious and 24,631 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Infliximab break down by patient sex as follows: Female: 116,761, Male: 67,689, Unknown: 754. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Infliximab adverse events are: age 43: 3,596 reports, age 44: 3,522 reports, age 40: 2,619 reports, age 53: 2,494 reports, age 60: 2,487 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Infliximab adverse event reports is Janssen Biotech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Infliximab include: Pain, Arthralgia, Fatigue, Product Use Issue, Rash. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Infliximab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Infliximab has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of reactions are serious, with 88.3% of reports being serious events.
Key safety signals identified in Infliximab's adverse event data include: Infusion-related reactions are a significant safety signal, with 18,649 reports.. Conditions aggravated by the drug are also a key safety signal, with 18,303 reports.. There is a notable increase in serious reactions, with 186,475 serious events reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Infliximab can cause serious infusion-related reactions, and patients should be monitored closely during and after administration. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Infliximab.
Patients should report any adverse reactions to their healthcare provider immediately. Follow the prescribed treatment plan and do not alter the schedule without consulting a healthcare professional.
Infliximab has 769,608 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Infliximab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of infliximab and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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