Side Effects of Entyvio: What You Need to Know

Key takeaways

• More common side effects of Entyvio (vedolizumab) include headache, fatigue, nausea, fever, and infections such as the common cold.
• Entyvio may lead to long-term side effects that can continue even after treatment has been discontinued. Examples include progressive multifocal leukoencephalopathy (a serious brain infection) and sepsis (a life threatening complication of this infection).
• If side effects from Entyvio become hard to manage, speak with your doctor about coping strategies or alternative treatment options.

Entyvio long-term side effects are an important consideration for people using this medication to manage Crohn’s disease or ulcerative colitis (UC). Entyvio works by lowering inflammation, which helps reduce symptoms of these conditions. Crohn’s disease and UC are autoimmune diseases, meaning the immune system mistakenly attacks healthy tissue and causes ongoing inflammation in the digestive tract.

Entyvio is supplied as a solution that a healthcare professional administers into a vein over approximately 30 minutes. After your first two doses, you may continue with intravenous infusions, or your doctor may transition you to a subcutaneous injection (an injection given under the skin). In some cases, a healthcare professional gives the injection, or you may be trained to self-inject at home.

Because Entyvio is a biologic drug made from living cells, it works in a targeted way within the immune system. If it effectively controls your symptoms, your doctor will usually recommend ongoing, long-term treatment. Understanding both short-term reactions and potential Entyvio long-term side effects can help you make informed decisions about your care.

What are the more common side effects of Entyvio?

Some individuals may experience mild or serious side effects while receiving Entyvio. Commonly reported mild side effects include:

• infection, such as the common cold or a respiratory infection
• headache
• fatigue (lack of energy)
• nausea
• fever

These effects are generally manageable and often improve as your body adjusts to treatment. However, monitoring symptoms closely is essential, especially during the first few infusions.

What are the mild side effects of Entyvio?

Mild side effects reported with Entyvio include:

• itchy skin and rash
• joint pain
• infections, such as a cold or respiratory infection
• headache
• nausea
• fever
• fatigue (lack of energy)
• cough
• back pain
• mouth pain
• pain in your arms or legs

For additional details about certain reactions, see the “Side effects explained” section below.

These symptoms are typically temporary and may be easier to manage with supportive care. If any side effect persists or becomes bothersome, consult your doctor or pharmacist. Do not stop using Entyvio unless your healthcare provider advises you to do so.

This summary does not include every possible side effect. Review Entyvio’s prescribing information for complete details, including safety data and clinical trial findings.

What are the serious side effects of Entyvio?

Serious side effects reported in people receiving Entyvio include:

• infusion-related reactions
• progressive multifocal leukoencephalopathy (a serious brain infection)
• other serious infections, such as salmonella
• sepsis (a life threatening complication of infection)
• liver problems

To better understand these risks, review the “Side effects explained” section.

If you notice serious side effects during treatment, contact your doctor immediately. If symptoms appear life threatening or you believe you are experiencing a medical emergency, call 911 or your local emergency number right away.

Note: Once the Food and Drug Administration (FDA) approves a medication, it continues to monitor reported side effects. If you experience a side effect while taking Entyvio and would like to report it, visit MedWatch or call 800-FDA-1088.

Allergic reaction

Entyvio may trigger an allergic reaction in some people.

Allergic symptoms can range from mild to severe.

What might help?

If you develop mild allergic symptoms, such as a slight rash, contact your doctor promptly. They may recommend treatment to ease symptoms and advise whether you can continue using Entyvio.

If severe symptoms occur, such as swelling or trouble breathing, call 911 or your local emergency number immediately. These reactions can be life threatening and require urgent medical attention.

If your doctor determines you experienced a serious allergic reaction to Entyvio, they may switch you to a different therapy.

What are Entyvio’s long-term side effects?

Entyvio long-term side effects may continue even after the medication has been stopped. While uncommon, they are important to recognize early.

Long-term side effects reported with Entyvio include:

• back pain
• liver problems
• progressive multifocal leukoencephalopathy (a serious brain infection)
• sepsis, a life threatening complication of infection

Because Entyvio (vedolizumab) works by modifying immune system activity, there is a potential for lasting immune-related complications. You can learn more about broader Vedolizumab side effects and how they are monitored during long-term therapy. Regular follow-up appointments and laboratory testing help detect complications early.

FAQ about Entyvio’s side effects

How long do Entyvio’s side effects last?

The duration varies depending on the specific side effect. For instance, a mild infection like a cold or flu is usually short lived. In contrast, some Entyvio long-term side effects, such as liver problems or persistent back pain, may last longer.

Your doctor may monitor you for signs of prolonged side effects, especially if you are on extended treatment. Early detection allows for timely management and may prevent complications.

If you experience troubling symptoms, speak with your doctor. They can suggest symptom-relief strategies or adjust your treatment plan if necessary.

Can Entyvio cause hair loss or weight gain?

No, hair loss and weight gain were not reported in studies of Entyvio.

However, other drugs used to manage UC or Crohn’s disease, such as prednisone, may cause hair loss or weight gain. If you notice these symptoms while receiving Entyvio, your doctor can help determine the underlying cause and suggest appropriate interventions.

Is anxiety one of Entyvio’s side effects?

Anxiety was not reported as a side effect in studies of Entyvio.

That said, anxiety may occur in people living with Crohn’s disease or UC. A 2021 systematic review suggests a possible connection between inflammatory bowel disease (IBD) and higher anxiety levels, particularly during flare-ups. If you feel increased anxiety during treatment, discuss it with your doctor to explore supportive care options.

How do Entyvio’s side effects compare with the side effects of Humira?

Entyvio and Humira (adalimumab) are both prescribed for UC and Crohn’s disease but act differently within the immune system. As a result, their side effect profiles overlap in some areas and differ in others.

Both medications may cause:

• infections
• rash
• headache
• nausea
• fever
• back pain

Entyvio may additionally cause fatigue, cough, and mouth, arm, or leg pain.

Injection site reactions, including itching, pain, and swelling, are more common with Humira.

Both drugs may lead to serious side effects such as allergic reaction and liver problems. Entyvio can cause progressive multifocal leukoencephalopathy (PML), whereas Humira has been associated with other neurological conditions, such as multiple sclerosis. For more insight into neurological risks, see Entyvio side effects brain.

Discuss with your doctor which medication aligns best with your medical history and treatment goals.

Can Entyvio cause eye-related side effects?

Although rare, eye-related side effects may occur with Entyvio.

Vision changes can signal progressive multifocal leukoencephalopathy (PML), a serious brain infection. Symptoms may include blurry vision, vision loss, weakness, confusion, and personality changes.

Liver problems linked to Entyvio may also cause jaundice (yellowing of the whites of your eyes).

If you notice any changes in vision or eye appearance during treatment, inform your doctor promptly. Diagnostic testing can help identify the cause and guide treatment.

Side effects explained

Below is more detailed information about certain side effects associated with Entyvio.

Progressive multifocal leukoencephalopathy, a serious brain infection

Although uncommon, progressive multifocal leukoencephalopathy (PML) is a potentially life threatening brain infection associated with Entyvio.

Possible symptoms include:

• neurological (nerve-related) side effects, such as confusion or changes in speech
• balance problems
• weakness
• blurry vision
• loss of vision

Seek immediate medical attention if you develop any of these symptoms.

What might help

Your doctor will monitor you for neurological symptoms throughout treatment. If PML is suspected, you will likely be advised to stop Entyvio and receive specialized care right away.

Itchy skin and rash

Itchy skin or rash can occur and are relatively common.

What might help

If a rash appears, contact your doctor to rule out an allergic or infusion-related reaction. Treatment may include topical creams or oral medications to relieve discomfort.

Joint pain

Joint pain is among the more frequently reported side effects.

What might help

Your doctor may recommend over-the-counter options such as Tylenol (acetaminophen) or other therapies to reduce discomfort. Always consult your healthcare provider before starting new medications.

Liver problems

Entyvio can cause liver problems, including elevated liver enzymes that may signal liver damage. Though rare, this reaction can be serious.

Watch for:

• jaundice (yellowing of the eyes or skin)
• belly pain
• nausea

What might help

Report symptoms immediately. Your doctor may order blood tests to evaluate liver function and determine whether treatment adjustments are necessary.

Keeping track of side effectsDuring your Entyvio treatment, consider recording any side effects you experience. Share these notes with your doctor, particularly when beginning a new medication or combination therapy. Include details such as:what dose you were takingwhen the side effect beganyour specific symptomshow it affected daily activitiesother medications you were usingany additional relevant informationTracking this information can help your doctor refine your treatment plan if needed.

Warnings for Entyvio

Before starting Entyvio, review your medical history with your doctor. Entyvio may not be appropriate if you have certain conditions or risk factors. Inform your doctor if you have:

• active or reoccurring infection, such as tuberculosis (TB)
• liver problems
• plans to receive a live vaccine, such as the nasal spray flu vaccine (FluMist)
• previous allergic reaction to this or a similar drug
• pregnancy or breastfeeding
• alcohol consumption

Disclaimer: HealthEH has made every effort to ensure that all information is accurate, comprehensive, and current. However, this content should not replace the guidance of a licensed healthcare professional. Always consult your doctor or another qualified healthcare provider before starting or stopping any medication. Drug information may change and may not include all possible uses, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of specific warnings does not mean a drug or combination is safe or appropriate for every individual.

Article resources

• Dubinsky MC, et al. (2021). Burden of comorbid anxiety and depression in patients with inflammatory bowel disease: A systematic literature review. https://www.tandfonline.com/doi/full/10.1080/17474124.2021.1911644
• Entyvio (vedolizumab) for injection, for intravenous use, Entyvio (vedolizumab) injection, for subcutaneous use,
• Entyvio pen (vedolizumab) injection, for subcutaneous use. (2024). https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&documentnumber=1
• Humira (adalimumab) injection, for subcutaneous use. (2024). https://www.rxabbvie.com/pdf/humira.pdf