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Generic Name: vedolizumab (VE doe LIZ ue mab)
Brand Names: Entyvio
Entyvio (vedolizumab) is used to treat ulcerative colitis and Crohn's disease. Includes Entyvio side effects, interactions and indications.
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Drug Information:
Entyvio (vedolizumab) reduces the effects of a substance in the body that can cause inflammation. Entyvio is used in adults with moderate to severe ulcerative colitis (UC), or moderate to severe Crohn's disease. Entyvio 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. Entyvio is usually given after other medicines have been tried without success. You should not use Entyvio if you are allergic to vedolizumab. Learn more

Entyvio Side Effects

Entyvio Side Effects

Note: This document contains side effect information about vedolizumab. Some of the dosage forms listed on this page may not apply to the brand name Entyvio.

In Summary

Common side effects of Entyvio include: nasopharyngitis. Other side effects include: upper respiratory tract infection and fatigue. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to vedolizumab: intravenous powder for solution

Along with its needed effects, vedolizumab (the active ingredient contained in Entyvio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking vedolizumab:

More common

  • Body aches or pain
  • chills
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Back pain
  • chest tightness
  • flushing
  • nausea and vomiting
  • weakness


  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest

Incidence not known

  • Abdominal or stomach pain
  • blurred vision
  • clay-colored stools
  • confusion
  • convulsions
  • dark urine
  • drowsiness
  • headache
  • loss of appetite
  • lower back or side pain
  • painful or difficult urination
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some side effects of vedolizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Difficulty with moving
  • muscle pain or stiffness
  • pain in the joints

For Healthcare Professionals

Applies to vedolizumab: intravenous powder for injection


The most common adverse reactions were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.


Common (1% to 10%): Rash, pruritus, eczema, erythema, night sweats, acne

Uncommon (0.1% to 1%): Folliculitis


Common (1% to 10%): Nausea, oropharyngeal pain, gastroenteritis, anal abscess, anal fissure, dyspepsia, constipation, abdominal distension, flatulence, hemorrhoids


Frequency not reported: Urinary tract infection


Frequency not reported: Elevations of transaminase, elevations of bilirubin, hepatitis, ALT elevations, AST elevations


Common (1% to 10%): Infusion related reactions (e.g., infusion site reaction, infusion site pain, infusion site irritation)

Very rare (less than 0.01%): Anaphylactic reaction (e.g., dyspnea, bronchospasm, urticaria, flushing, rash, increased blood pressure, increased heart rate)


Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Bacterial sepsis, septic shock

Frequency not reported: Sepsis, tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, cytomegaloviral colitis


Very common (10% or more): Arthralgia (12%)

Common (1% to 10%): Back pain, pain in extremities

Nervous system

Very common (10% or more): Headache (12%)

Common (1% to 10%): Paresthesia


Rare (less than 0.1%): Transitional cell carcinoma, carcinoid tumor of the appendix

Frequency not reported: B-cell lymphoma, breast cancer, colon cancer, malignant hepatic neoplasm, malignant lung neoplasm, malignant melanoma, lung cancer of primary neuroendocrine carcinoma, renal cancer, squamous cell carcinoma


Common (1% to 10%): Pyrexia, fatigue


Very common (10% or more): Nasopharyngitis (13%)

Common (1% to 10%): Upper respiratory tract infection, cough, bronchitis, influenza, sinusitis

Very rare (less than 0.01%): Pneumonia


Uncommon (0.1% to 1%): Infusion site reaction (e.g., infusion site pain, infusion site irritation), infusion related reaction, chills, feeling cold


Common (1% to 10%): Hypertension

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Entyvio