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

Summary

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.

General

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]