Key takeaways

  • More common side effects of Entyvio (vedolizumab) include headache, fatigue, nausea, fever, and infection, such as the common cold.
  • Entyvio may cause long-term side effects, which may last even after you have stopped treatment. Examples include progressive multifocal leukoencephalopathy (a serious brain infection) and sepsis (a life threatening complication of this infection).
  • If side effects from Entyvio become difficult to manage, talk with your doctor about coping tips or other treatment options.

Entyvio is a brand-name prescription drug used to treat Crohn’s disease and ulcerative colitis in adults.

Entyvio comes as a liquid solution administered by a healthcare professional via intravenous (IV) infusion. This is an injection into a vein given over time — in this case, over the course of about 30 minutes.

After your first two doses, you may continue to receive Entyvio as an infusion, or your doctor may have you switch to a subcutaneous injection (under your skin). A healthcare professional can administer it, or you may self-inject the medication at home.

Note: This article is based on the United States prescribing information for Entyvio. Outside of the United States, forms of this medication may vary.

Some people may have mild to serious side effects during Entyvio treatment. The following lists do not include all possible side effects of this medication. See Entyvio’s prescribing information for details.

Examples of mild side effects that people receiving Entyvio have reported include:

Experiencing side effects? After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking this drug and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Examples of mild side effects that have been reported with Entyvio include:

To learn more about some of these side effects, see the “Side effects explained” section.

Most of these side effects should be temporary, and some may be easily managed. But if you have any ongoing or bothersome symptoms, talk with your doctor or pharmacist. And do not stop using Entyvio unless your doctor recommends it.

Serious side effects that people receiving Entyvio have reported include:

To learn more about some of these side effects, see the “Side effects explained” section.

If you develop serious side effects during Entyvio treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Allergic reaction

For some people, Entyvio can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious.

What might help?

If you have mild symptoms of an allergic reaction, such as a mild skin rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep using Entyvio.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Entyvio, they may have you switch to a different treatment.

Entyvio may cause long-term side effects, which may last even after you’ve stopped treatment.

Long-term side effects that people receiving Entyvio have reported include:

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

It varies depending on the type of side effect. For example, an infection such as a cold or flu likely won’t be long term. But other side effects, such as liver problems or back pain, may last much longer.

Talk with your doctor about monitoring for side effects. They can provide early treatment or adjust your prescription as needed.

No, Entyvio doesn’t typically cause hair loss or weight gain. People receiving Entyvio in studies didn’t report either of these side effects.

Other medications used to help treat ulcerative colitis (UC) or Crohn’s disease may cause hair loss or weight gain. For example, prednisone may be used to treat flare-ups of either of these conditions and can cause both hair loss and weight gain.

If you experience either of these side effects during Entyvio treatment, talk with your doctor. They can help determine the cause and recommend ways to manage them.

Although uncommon, it’s possible for Entyvio to cause eye-related side effects.

Vision changes may be a sign of a serious condition called progressive multifocal leukoencephalopathy. This is a rare but serious infection in your brain that can cause blurry vision and loss of vision. It can also result in other serious side effects, such as weakness, confusion, and changes in personality or memory.

In addition, liver problems can occur with Entyvio and a symptom of liver disease is jaundice (which involves yellowing of the whites of your eyes).

If you notice any eye-related side effects during Entyvio treatment, tell your doctor right away. They’ll likely order tests to determine what’s causing your eye problems. Based on what they find out, they may be able to recommend ways to treat your eye-related side effects.

Learn more about some of the side effects Entyvio may cause.

Progressive multifocal leukoencephalopathy (PML), a serious brain infection

Although rare, it’s possible to develop PML from Entyvio. This condition is a serious, potentially life threatening infection that affects your brain.

Even though PML is rare, you should be aware of its possible symptoms, including:

If you develop symptoms of PML, let your doctor know right away.

What might help

Throughout your Entyvio treatment, your doctor will monitor you for symptoms of PML. If you develop any symptoms of this condition, go to the hospital or contact your doctor right away.

Itchy skin and rash

Entyvio can cause itchiness or a skin rash. These are common side effects of the drug.

What might help

If you develop itchy skin or a rash during Entyvio treatment, contact your doctor. A rash can be a sign of an allergic reaction or an infusion-related reaction, though this is rare.

Your doctor will determine if the rash is serious and whether it needs treatment. If it does, they can recommend a cream or medication to soothe your itchy skin or rash.

Liver problems

Entyvio may cause liver problems. Some people who received this medication had increased liver enzymes, which may indicate liver damage. Although this side effect is rare, it can be very serious or even life threatening.

What might help

Call your doctor right away if you experience symptoms of liver damage such as jaundice (yellowing of your skin or the whites of your eyes), abdominal pain, or nausea. Your doctor can order blood tests to determine whether there’s a problem with your liver. If there is, they’ll work with you to develop an appropriate treatment plan, which may include stopping Entyvio.

Before receiving Entyvio, discuss your health history with your doctor. This drug may not be right for you if you have certain medical conditions or other factors affecting your health.

Be sure to tell your doctor if any of the following apply to you:

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