Vedolizumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 17, 2025.

Applies to vedolizumab: powder for solution, solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Vedolizumab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.

Your body's ability to fight an infection may be reduced with this medicine. Avoid being near people who are sick and wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of getting a rare brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, a fever or headache, seizures, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

While you are being treated with vedolizumab, do not have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive vedolizumab.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of vedolizumab

Along with its needed effects, vedolizumab 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:

Other side effects of vedolizumab

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:

For healthcare professionals

Applies to vedolizumab: intravenous powder for injection, subcutaneous solution.

General adverse events

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.^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus, eczema, erythema, night sweats, acne
• Uncommon (0.1% to 1%): Folliculitis^[Ref]

Gastrointestinal

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

Genitourinary

• Frequency not reported: Urinary tract infection^[Ref]

Hepatic

• Frequency not reported: Elevations of transaminase, elevations of bilirubin, hepatitis, ALT elevations, AST elevations^[Ref]

Hypersensitivity

• 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)^[Ref]

Immunologic

• 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^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (12%)
• Common (1% to 10%): Back pain, pain in extremities^[Ref]

Nervous system

• Very common (10% or more): Headache (12%)
• Common (1% to 10%): Paresthesia^[Ref]

Oncologic

• 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^[Ref]

Other

• Common (1% to 10%): Pyrexia, fatigue^[Ref]

Respiratory

• 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^[Ref]

Local

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

Cardiovascular

• Common (1% to 10%): Hypertension^[Ref]

See also:

Frequently asked questions

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Further information

Vedolizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer