Vedolizumab: Uses & Side Effects

Vedolizumab (Entyvio) reduces the effects of a substance in the body that can cause inflammation.

Vedolizumab is used in adults with moderate to severe ulcerative colitis (UC), or moderate to severe Crohn’s disease.

Vedolizumab treats active disease and may help keep UC or Crohn’s symptoms under control long term. Vedolizumab may also reduce the need for steroid medicines in helping to control symptoms long term.

Vedolizumab is usually given after other medicines have been tried without success.

Before taking this medicine

You should not use vedolizumab if you are allergic to it.

To make sure vedolizumab is safe for you, tell your doctor if you have:

  • an active or recent infection;
  • tuberculosis (or if you have close contact with someone who has tuberculosis);
  • signs of infection such as fever, cough, or flu symptoms;
  • open sores or skin wounds;
  • weak immune system (caused by disease or by using certain medicine); or
  • if you are scheduled to receive any vaccines.

You should be up to date with all needed vaccinations before receiving vedolizumab.

FDA pregnancy category B. Vedolizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of vedolizumab on the baby.

It is not known whether vedolizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give vedolizumab to anyone under 18 years old without medical advice.

Side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel warm or tingly, or if you have a severe headache, fast heart rate, pounding in your neck or ears, chest tightness, or trouble breathing.

Some people using a medicine similar to vedolizumab have developed a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Stop using vedolizumab and call your doctor at once if you have:

  • fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;
  • pain, warmth, swelling, or oozing around your anal area;
  • nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;
  • cough, pain when swallowing; or
  • liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • fever, sore throat, flu symptoms;
  • cold symptoms such as stuffy nose, sinus pain, sneezing, cough;
  • pain in your arms or legs;
  • tired feeling;
  • headache, joint pain, back pain;
  • rash, itching; or
  • nausea.


Keywords: Vedolizumab; Entyvio.

* The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.