Vedolizumab Side Effects
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
Side effects requiring immediate medical attention
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:
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- difficulty with swallowing
- 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
- dark urine
- loss of appetite
- lower back or side pain
- painful or difficult urination
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Side effects not requiring immediate medical attention
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
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]
Uncommon (0.1% to 1%): Folliculitis[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)
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Bacterial sepsis, septic shock
Very common (10% or more): Arthralgia (12%)
Common (1% to 10%): Back pain, pain in extremities[Ref]
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
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
- Is Entyvio an immunosuppressant or a biologic?
- How much does Entyvio cost per month?
- Can I take antibiotics while on Entyvio?
- How long has Entyvio been on the market?
- Does Medicaid cover Entyvio?
More about vedolizumab
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (136)
- En español
- Drug class: selective immunosuppressants
Related treatment guides
1. "Product Information. Entyvio (vedolizumab)." Takeda Pharmaceuticals America (2014):
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.