For adults with moderate to severe ulcerative colitis (UC).
†Quarterly analysis of claims data from January 2023–December 2025.
What are the most common side effects with ENTYVIO?
In clinical trials, the 5 most common side effects of ENTYVIO included cold symptoms, headache, joint pain, nausea, and fever. Please see table below for additional common side effects.
Possible side effects with ENTYVIO
These side effects were experienced by 3% or more of people taking ENTYVIO IV and 1% or more of people taking placebo in clinical trials.
ENTYVIO (out of 1434 people) | Placebo (out of 297 people) | |
|---|---|---|
| Cold symptoms | 13% | 7% |
| Headache | 12% | 11% |
| Joint pain | 12% | 10% |
| Nausea | 9% | 8% |
| Fever | 9% | 7% |
| Infections of the nose & throat | 7% | 6% |
| Tiredness | 6% | 3% |
| Cough | 5% | 3% |
| Bronchitis | 4% | 3% |
| Flu | 4% | 2% |
| Back pain | 4% | 3% |
| Rash | 3% | 2% |
| Itching | 3% | 1% |
| Sinus infection | 3% | 1% |
| Throat pain | 3% | 1% |
| Pain in extremities | 3% | 1% |
Some patients using the ENTYVIO Pen experienced a range of injection site reactions, including pain, swelling, itching, hives, bruising, rash, or redness at the injection site. In trials for UC, injection site reactions were reported in 10% (11/106) of patients using the ENTYVIO Pen. In trials for Crohn’s, injection site reactions were reported in 3% (8/275) of patients using the ENTYVIO Pen.
These are not all the possible side effects of ENTYVIO. Please see the full Important Safety Information below, or talk to your healthcare provider for more information.
ENTYVIO has a proven safety record*
*4 clinical trials, each lasting 52 weeks, evaluated safety vs placebo in more than 3300 adults (UC, Crohn's, and healthy volunteers).
It’s important to have a conversation with your doctor about the safety of any medication you might take. Make sure to ask about the safety information of ENTYVIO, and see the full Important Safety Information below.
“Safety is always important to me, so I talked with my doctor about ENTYVIO and its possible side effects.”
– KRISTA, real ENTYVIO patient
What you should know about ENTYVIO (vedolizumab)
Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients. ENTYVIO may cause serious side effects, including infusion-related and serious allergic reactions, while receiving ENTYVIO or several hours after treatment. ENTYVIO may increase your risk of serious infections. If your healthcare provider feels that you are at risk for tuberculosis (TB), you may be treated with medicine for TB before you begin treatment with ENTYVIO. Although unlikely, progressive multifocal leukoencephalopathy (PML), a rare, serious brain infection caused by a virus, cannot be ruled out. Liver problems can occur with ENTYVIO.
Talk to your healthcare provider and see the full Important Safety Information below for more information about the possible side effects of ENTYVIO.
Additional questions
Additional questions
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