Infliximab
According to the FDA label: Infliximab is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
55,550 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Infliximab in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 19,435 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Condition Aggravated 12,325 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Drug Ineffective 11,868 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Intentional Product Use Issue 9,395 reports
A report that the medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Full definition in the glossary →Arthralgia 7,752 reports
Fatigue 6,253 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pain 6,068 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Inappropriate Schedule of Product Administration 5,523 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Nausea 5,196 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Weight Increased 5,179 reports
Headache 5,054 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Malaise 4,961 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Rheumatoid Arthritis 4,911 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Diarrhoea 4,898 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Rash 4,571 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 26,041 |
| Male | 16,035 |
| Unknown | 63 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,441 |
| 18-34 | 7,471 |
| 35-49 | 10,864 |
| 50-64 | 9,068 |
| 65-74 | 4,278 |
| 75+ | 1,741 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Infliximab. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 45,292 |
| Hospitalization | 19,896 |
| Death | 6,500 |
| Life-Threatening | 5,490 |
| Disability | 5,364 |
| Non-Serious | 1,637 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Infliximab. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 1 |
| 2003 | 11 |
| 2004 | 271 |
| 2005 | 759 |
| 2006 | 336 |
| 2007 | 524 |
| 2008 | 480 |
| 2009 | 723 |
| 2010 | 477 |
| 2011 | 404 |
| 2012 | 787 |
| 2013 | 258 |
| 2014 | 260 |
| 2015 | 387 |
| 2016 | 568 |
| 2017 | 879 |
| 2018 | 1,673 |
| 2019 | 3,484 |
| 2020 | 5,414 |
| 2021 | 4,601 |
| 2022 | 8,261 |
| 2023 | 8,506 |
| 2024 | 6,795 |
| 2025 | 8,216 |
| 2026 (partial) | 1,475 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Infliximab
In FDA adverse event reports that mention Infliximab, these medications appeared most often in the same report.
- Methotrexate (18,999 reports)
- Prednisone (16,561 reports)
- Adalimumab (15,100 reports)
- Adalimumab-adaz (10,163 reports)
- Etanercept (9,752 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026