Infliximab: adverse event reports filed with FDA

52,582

reports as suspect product

0.3% of all reports · about 2,338 a year

7,092

reports, 12 months to June 2026

6,469 in the 12 months before

97.3%

marked serious by the reporter

56.2% across the class

11.9%

record death among outcomes, as reported

6,245 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Infliximab reports recording the termmedian drug in tumor necrosis factor blocker

1. Off label useused for a purpose or in a way not on the label37.1%19,488
2. Condition aggravatedthe condition being treated got worse23.6%12,397
3. Drug ineffectivethe medicine did not work as expected20.5%10,774
4. Intentional product use issuedeliberate use not as intended18.8%9,906
5. Arthralgiajoint pain14.4%7,586
6. Fatiguetiredness11.5%6,032
7. Inappropriate schedule of product administrationthe product was taken at the wrong times10.9%5,712
8. Painpain, site not specified10.8%5,702
9. Weight increasedweight gain9.8%5,141
10. Nauseafeeling sick9.4%4,927
11. Headachehead pain9.3%4,868
12. Malaisegeneral feeling of being unwell9.2%4,820
13. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease8.7%4,556
14. Diarrhoealoose or frequent stools8.6%4,517
15. Rashskin rash8.3%4,363
16. Drug intolerancethe medicine was not tolerated8%4,191
17. Weight decreasedweight loss7.6%4,020
18. Infusion related reactiona reaction during or soon after an infusion7.6%3,984
19. Pyrexiafever7.2%3,803
20. Hypertensionhigh blood pressure7.1%3,710
21. Hypersensitivityan allergic-type reaction7%3,699
22. Treatment failurethe treatment did not work7%3,686
23. Product use issuea problem in how the product was used7%3,666
24. Joint swellinga swollen joint7%3,664
25. Synovitis6.7%3,547
26. Vomitingbeing sick6.6%3,480
27. Dyspnoeashortness of breath6.6%3,461
28. Alopeciahair loss6.3%3,320
29. Abdominal discomfortstomach discomfort6.3%3,317
30. Nasopharyngitisa cold6.3%3,315

Top 30 of 3,883 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 17 drugs in the tumor necrosis factor blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 1,064,042 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 13.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 52,582 reports.

Drugs most often listed in the same reports

Other products listed in reports where Infliximab is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the tumor necrosis factor blocker class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Infliximab as a suspect or interacting product; reports listing it only as a concomitant medication (6,171) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.