OpenClaim

Vedolizumab Side Effects

The most commonly reported side effects of vedolizumab include off label use, colitis ulcerative, and crohn^s disease, based on 80,227 FDA adverse event reports from 2012 to 2025. 11.7% of reports found the drug to be ineffective.

Vedolizumab side effects

Percentages show how often each reaction appears relative to total reports for vedolizumab.

1
Off Label Use27.2%21,828
2
Colitis Ulcerative18.1%14,518
3
Crohn^s Disease13.3%10,635
4
Drug Ineffective11.7%9,420
5
Diarrhoea10.2%8,173
6
Abdominal Pain8.7%6,953
7
Fatigue7.5%5,981
8
Haematochezia7.1%5,657
9
Frequent Bowel Movements6.1%4,907
10
Arthralgia5.5%4,447
11
Malaise5.1%4,084
12
Nausea4.9%3,969
13
Headache4.9%3,919
14
Inappropriate Schedule Of Product Administration4.5%3,647
15
Product Dose Omission Issue4.2%3,409

These are voluntary reports and do not establish that vedolizumab caused these reactions.

Report severity

86.4%Serious69,324 reports
29.7%Hospitalizations23,813 reports
4.9%Fatal3,916 reports

Seriousness is determined by the reporter, not by OpenClaim.

Vedolizumab drug interactions

Other drugs that appear in adverse event reports alongside vedolizumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Infliximab6.0%4,850
2
Adalimumab5.5%4,448
3
Mesalamine3.3%2,631
4
Prednisone3.1%2,479
5
Methotrexate2.7%2,206
6
Ustekinumab2.7%2,134
7
Pantoprazole-sodium2.5%2,008
8
Azathioprine2.0%1,632
9
Hydrocortisone2.0%1,569
10
Tofacitinib1.7%1,351
11
Acetaminophen1.5%1,227
12
Golimumab1.5%1,165
13
Sulfasalazine1.3%1,061
14
Certolizumab-pegol1.3%1,055
15
Etanercept1.2%983

Taken alongside

1
Prednisone16.5%13,202
2
Mesalamine12.3%9,898
3
Ergocalciferol7.1%5,731
4
Budesonide5.6%4,508
5
Azathioprine5.2%4,179
6
Acetaminophen4.3%3,418
7
Pantoprazole-sodium3.9%3,145
8
Calcium3.8%3,025
9
Methotrexate3.2%2,596
10
Levothyroxine-sodium3.2%2,567
11
Cyanocobalamin3.1%2,472
12
Buspirone-hydrochloride2.9%2,320
13
Aspirin2.7%2,173
14
Folic-acid2.7%2,134
15
Hydrocortisone2.6%2,098

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports vedolizumab side effects

51.9% of vedolizumab adverse event reports involve female patients and 40.7% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.9%
Male40.7%
Unknown7.4%

Age group

< 20.4%
2–111.0%
12–172.3%
18–6472.6%
65+23.7%

What is vedolizumab used for

Conditions and purposes for which patients were taking vedolizumab when the adverse event was reported.

Abdominal AbscessAbdominal PainAbdominal Pain UpperAbscessAbscess IntestinalAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In SkinAcute Haemorrhagic Ulcerative ColitisAcute SinusitisAdenocarcinoma Of ColonAdverse Drug ReactionAnaemiaAnal FissureAnal Fistula

Showing 15 of 558 indications

Vedolizumab brand names and reporting trend

Vedolizumab is sold under the brand name Entyvio.

Brand names

Entyvio156,760

Quarterly reports (20122025)

20122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking vedolizumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.