Vedolizumab Side Effects

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

Applies to vedolizumab: powder for solution, solution.

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:

More common side effects

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

Less common side effects

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

Rare side effects

• 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

Incidence not known

• bloating
• blurred vision
• clay-colored stools
• confusion
• constipation
• dark urine
• drowsiness
• headache
• indigestion
• loss of appetite
• lower back or side pain
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• seizures
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

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:

More common side effects

• difficulty with moving
• joint pain
• muscle pain or stiffness

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]

Frequently asked questions

• How much does Entyvio cost per month?
• Is Entyvio an immunosuppressant or a biologic?
• Can I take antibiotics while on Entyvio?
• How long has Entyvio been on the market?
• Does Medicaid cover Entyvio?
• Is Entyvio used to treat Crohn’s disease?

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