Infliximab-dyyb: adverse event reports filed with FDA

2,027

reports as suspect product

0% of all reports · about 234 a year

1,394

reports, 12 months to June 2026

307 in the 12 months before

86.3%

marked serious by the reporter

56.2% across the class

3.5%

record death among outcomes, as reported

70 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-dyyb reports recording the termmedian drug in tumor necrosis factor blocker

1. Intentional dose omission28.8%584
2. Off label useused for a purpose or in a way not on the label27.2%552
3. Inappropriate schedule of product administrationthe product was taken at the wrong times25.9%525
4. Product dose omission issuea dose was missed11.1%226
5. Intentional product use issuedeliberate use not as intended11.1%224
6. Overdosea dose above the recommended amount10.4%211
7. Arthralgiajoint pain8.6%174
8. Fatiguetiredness8.5%172
9. Diarrhoealoose or frequent stools8%163
10. Therapy interrupted7.8%159
11. Weight decreasedweight loss7.8%158
12. Weight increasedweight gain7.7%157
13. Harvey-Bradshaw index increased7.7%156
14. Crohn's disease7.6%155
15. Headachehead pain6.9%140
16. Abdominal painstomach or belly pain6.7%136
17. Suspected off label use6.7%135
18. Condition aggravatedthe condition being treated got worse6.4%130
19. Colitis ulcerative6.3%127
20. Malaisegeneral feeling of being unwell6.1%124
21. Nauseafeeling sick6%121
22. Painpain, site not specified5.9%120
23. Drug ineffectivethe medicine did not work as expected5.6%114
24. Influenzaflu5.6%113
25. Nasopharyngitisa cold5.5%112
26. Haematocheziablood in the stool5.3%108
27. Underdoseless than the intended dose5.3%108
28. Injection site painpain where the injection was given5.1%104
29. Pyrexiafever4.5%91
30. Dizzinesslight-headedness or unsteadiness3.6%73

Top 30 of 688 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. 15.1% 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 2,027 reports.

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-dyyb as a suspect or interacting product; reports listing it only as a concomitant medication (27) 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.