Entyvio Side Effects

Generic Name: vedolizumab

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

For the Consumer

Applies to vedolizumab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by vedolizumab (the active ingredient contained in Entyvio). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking vedolizumab, check with your doctor or nurse immediately:

• 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

Minor Side Effects

Some of the side effects that can occur with vedolizumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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]

Not all side effects for Entyvio may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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