Entyvio Side Effects

Generic Name: vedolizumab

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:

• 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

• 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

• 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:

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

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^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, oropharyngeal pain
Frequency not reported: Anal abscess^[Ref]

Genitourinary

Frequency not reported: Urinary tract infection

Hepatic

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

Hypersensitivity

Infusion related reactions were nausea, headache, pruritus, dizziness, fatigue, pyrexia, urticaria and vomiting.
Anaphylaxis symptoms were dyspnea, bronchospasm, urticaria, flushing, rash and increased blood pressure and heart rate, and were managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.^[Ref]

Common (1% to 10%): Infusion related reaction
Rare (less than 0.1%): Anaphylaxis^[Ref]

Immunologic

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%)^[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^[Ref]

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.

Medical Disclaimer