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Vedolizumab Side Effects

In Summary

Commonly reported side effects of vedolizumab 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 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
  • 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
Less common
  • Back pain
  • chest tightness
  • flushing
  • nausea and vomiting
  • weakness
Rare
  • 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
Incidence not known
  • 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:

More common
  • 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]

References

1. "Product Information. Entyvio (vedolizumab)." Takeda Pharmaceuticals America, Lincolnshire, IL.

Some side effects of vedolizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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