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Entyvio Side Effects

Generic name: vedolizumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 27, 2023.

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


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

Applies to vedolizumab: parenteral diluted solution, parenteral powder for iv infusion, parenteral reconstituted solution.

Side effects include:

Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: Nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities.

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.[Ref]


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

Uncommon (0.1% to 1%): Folliculitis[Ref]


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


Frequency not reported: Urinary tract infection[Ref]


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


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]


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]


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]


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]


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


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]


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


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

Frequently asked questions


1. Product Information. Entyvio (vedolizumab). Takeda Pharmaceuticals America. 2014.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.