Entyvio: adverse event reports filed with FDA

23,511

reports as suspect product

0.1% of all reports · about 1,754 a year

2,171

reports, 12 months to June 2026

2,453 in the 12 months before

57.5%

marked serious by the reporter

48.8% across the class

5.8%

record death among outcomes, as reported

1,355 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 Entyvio reports recording the termmedian drug in integrin receptor antagonist

1. Off label useused for a purpose or in a way not on the label14.1%3,315
2. Drug ineffectivethe medicine did not work as expected11.9%2,799
3. No adverse eventno adverse event was reported9.5%2,243
4. Colitis ulcerative9.5%2,237
5. Fatiguetiredness7.9%1,850
6. Arthralgiajoint pain6.8%1,594
7. Headachehead pain6.7%1,583
8. Diarrhoealoose or frequent stools6.7%1,564
9. Crohn's disease6.6%1,553
10. Nauseafeeling sick5.4%1,275
11. Pyrexiafever5.1%1,195
12. Abdominal painstomach or belly pain4.8%1,132
13. Condition aggravatedthe condition being treated got worse4.7%1,108
14. Painpain, site not specified4.5%1,069
15. Rashskin rash4.5%1,069
16. Weight decreasedweight loss4.5%1,052
17. Frequent bowel movements4.2%991
18. Haematocheziablood in the stool3.6%856
19. Malaisegeneral feeling of being unwell3.6%846
20. Dyspnoeashortness of breath3.5%814
21. Pain in extremitypain in an arm or leg3.4%800
22. Pregnancypregnancy3.3%783
23. Nasopharyngitisa cold3.2%764
24. Alopeciahair loss3.2%745
25. Vomitingbeing sick3.1%721
26. Infusion related reactiona reaction during or soon after an infusion3%697
27. Pneumonialung infection3%696
28. Pruritusitching2.9%676
29. Abdominal discomfortstomach discomfort2.8%670
30. Dizzinesslight-headedness or unsteadiness2.8%653

Top 30 of 1,784 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 4 drugs in the integrin receptor antagonist 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 258,020 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. 55.2% 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 23,511 reports.

Drugs most often listed in the same reports

Other products listed in reports where Entyvio 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 integrin receptor antagonist 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 Entyvio as a suspect or interacting product; reports listing it only as a concomitant medication (2,252) 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.