Entyvio’s Side Effects: What to Know

Entyvio is a brand-name prescription drug. It’s a type of drug called an integrin receptor antagonist. It contains the active drug vedolizumab.

Entyvio comes as a powder that’s made into a solution, and it’s given by IV infusion.

Entyvio is approved by the Food and Drug Administration (FDA) to treat the conditions below in adults:

• moderate to severe Crohn’s disease 
• moderate to severe ulcerative colitis

Doctors can prescribe Entyvio for long-term use. Similar to other drugs, Entyvio may cause side effects. Read below for information about possible side effects, including common, mild, and serious ones.

For a general overview of Entyvio, including details about its uses, see this article.

If you’d like to receive Entyvio, search here to find a healthcare professional who might prescribe it.

Some of Entyvio’s side effects may be more common than others. These side effects may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about any side effects with Entyvio.

In Entyvio’s clinical studies, these were some side effects that occurred more often:

• fever
• nasopharyngitis (inflammation of the throat and sinuses)
• nausea
• pain in the joints
• headache*

* For more information about this side effect, see “Entyvio: Side effects explained” below.

Entyvio can cause mild side effects, which are listed below. However, this list doesn’t include all possible mild side effects. To learn more about Entyvio’s side effects, view the drug’s prescribing information.

Entyvio’s mild side effects include:

• cough
• fatigue
• fever
• mild infections, such as the common cold, influenza (the flu), or a sinus infection
• nasopharyngitis (inflammation of the throat and sinuses)
• nausea
• pain in the joints, legs, arms, back, or throat 
• skin side effects, such as rash or itchiness*
• headache*
• bronchitis (inflammation of the airways)*

The side effects listed above may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about side effects with Entyvio.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while receiving Entyvio and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Entyvio: Side effects explained” below.

It’s possible to have serious side effects with Entyvio. Serious side effects are listed below, but this list may not include all possibilities. To learn more about Entyvio’s side effects, view the drug’s prescribing information.

Call your doctor right away if you have serious side effects with Entyvio. However, if you think you’re having a medical emergency or have life threatening side effects, call 911 or your local emergency number.

Serious side effects of Entyvio and their possible symptoms include:

• Serious infection, such as tuberculosis, which may lead to sepsis (a serious, life threatening response to infection that can cause organ damage). Symptoms of infection can include:
  • cough
  • chills
  • fatigue
  • fever
• Liver problems, such as hepatitis (inflammation of the liver). Symptoms can include:
  • abdominal pain
  • diarrhea, nausea, or vomiting
  • loss of appetite
  • jaundice
• Infusion side effects.*
• Certain cancers.*
• Allergic reaction.*

* For more information about this side effect, see “Entyvio: Side effects explained” below.

Here are some common questions about the drug’s side effects and answers to them. Talk with your doctor if you have other questions about this drug.

In rare cases, Entyvio may cause a certain brain-related side effect.

Specifically, Entyvio may cause a brain infection called progressive multifocal leukoencephalopathy (PML). PML wasn’t reported as a side effect in clinical studies of the drug. However, there has been at least one report of PML with Entyvio since the drug’s initial studies were completed.

PML is a rare but serious and life threatening infection. It’s caused by a virus that attacks the central nervous system. Possible symptoms of PML include:

• confusion
• vision problems, such as vision loss
• trouble using your arms and legs, which may cause problems with balance

During Entyvio treatment, your doctor will monitor you for symptoms of PML. If you have any of the symptoms listed above while receiving Entyvio, call 911 or your local emergency number immediately.

Doctors typically will not prescribe Entyvio in combination with other drugs that increase the risk of PML. An example is the Crohn’s disease drug natalizumab (Tysabri). If you receive natalizumab, your doctor will recommend a different treatment option other than Entyvio.

It’s not likely. Weight gain wasn’t reported as a side effect in clinical studies of Entyvio.

However, symptoms of Crohn’s disease and ulcerative colitis may lead to weight loss. Keep in mind that Entyvio is approved to treat these conditions. So you may gain weight over time while receiving Entyvio as symptoms of your condition ease.

To learn more about weight gain and Entyvio, talk with your doctor or pharmacist.

Although rare, long-term side effects are possible with Entyvio.

Examples of long-term side effects that can happen with Entyvio include:

• serious infection, which may lead to sepsis (a serious, life threatening response to infection that can cause organ damage)
• liver problems, such as hepatitis (inflammation of the liver)
• certain cancers*

Your doctor or pharmacist can advise on your risk of long-term side effects with Entyvio. They’ll also recommend what to do if these side effects occur.

* For more information about this side effect, see “Entyvio: Side effects explained” below.

Entyvio isn’t likely to cause hair loss. This side effect wasn’t reported in clinical studies of the drug.

However, inflammatory bowel disease (IBD) can cause hair loss. Entyvio is prescribed to treat Crohn’s disease and ulcerative colitis, which are two types of IBD. So you could have hair loss while receiving Entyvio to treat these conditions. However, your hair loss isn’t likely to be caused by Entyvio itself.

If you’re concerned about hair loss with Entyvio, talk with your doctor or pharmacist.

You may have certain side effects after receiving an Entyvio infusion. (Keep in mind that the drug is given by IV infusion.) These are sometimes called “infusion side effects.”

Infusion side effects can happen during or shortly after an Entyvio infusion. However, these side effects weren’t common in clinical studies of the drug. Examples include:

• headache
• itching
• shortness of breath

For more information about infusion side effects, see “Entyvio: Side effects explained” below.

Here’s detailed information about some of Entyvio’s side effects.

Entyvio may cause infusion side effects. These are side effects that happen during or shortly after an infusion of Entyvio. (Keep in mind that the drug is given by IV infusion.) However, these side effects weren’t common in clinical studies of the drug.

Below are examples of infusion side effects that can happen with Entyvio:

• headache
• fatigue
• dizziness
• nausea or vomiting
• fever
• shortness of breath 
• high blood pressure
• swollen throat, face, or lips

Other infusion side effects with Entyvio are similar to those of allergic reaction. For more information, see “Allergic reaction” below.

Entyvio infusions are typically given in an infusion center, hospital, or clinic. The healthcare professional who gives the infusion will monitor you for side effects. However, these side effects can happen up to several hours after an infusion ends. So it’s important to let your healthcare professional know if you have any of the symptoms listed above after your infusion.

If you’re concerned about having infusion side effects with Entyvio, talk with your doctor.

Certain skin side effects may occur with Entyvio. Examples include rash and itchiness, which were common in clinical studies of the drug.

It’s important to remember that rash and itching are also symptoms of other possible side effects of Entyvio. These include infusion side effects (see “Infusion side effects” above) and allergic reaction (see “Allergic reaction” below).

If you have skin side effects while receiving Entyvio, talk with your doctor. However, if your symptoms seem severe or life threatening, call 911 or your local emergency number right away.

You’ll receive Entyvio infusions from a healthcare professional in an infusion center, hospital, or clinic. They’ll monitor you for infusion side effects, including skin side effects, during your infusions. Keep in mind that infusion side effects can happen up to several hours after your infusion ends. Tell your healthcare professional if you have any skin side effects within a few hours after your infusion ends.

If you have rash, itching, or other infusion side effects, your doctor will recommend whether you should continue receiving Entyvio infusions.

Headache may occur with Entyvio. This was a common side effect in clinical studies of the drug.

Keep in mind that headache is also a possible infusion side effect with Entyvio. For details about these side effects, see “Infusion side effects” above.

If you have headaches with Entyvio, talk with your doctor. They can suggest ways to help ease your discomfort.

A healthcare professional will give you Entyvio infusions in an infusion center, hospital, or clinic. Headache and other infusion side effects can happen during your infusion or up to several hours after it ends. Your healthcare professional will monitor you for side effects, such as headache, while they administer your infusion. Be sure to let them know if you have a headache within a few hours after your infusion ends.

If you have a headache or other infusion side effects, your doctor will recommend whether you should continue receiving Entyvio infusions.

Certain cancers may occur with Entyvio. However, these cancers were very rare in clinical studies of the drug. It isn’t known for certain whether these cancers were related to Entyvio treatment.

Below are cancers that have been reported with Entyvio, along with possible symptoms of each.

Tell your doctor right away if you have symptoms of cancer while receiving Entyvio. They can order certain tests to check for cancer, if needed. Your doctor can also recommend whether you should continue receiving Entyvio or switch to a different treatment.

Bronchitis (inflammation of the airways) can occur with Entyvio. This was one of the more common side effects in clinical studies of the drug.

Common symptoms of bronchitis include:

• chest pain or congestion
• cough, with or without phlegm
• fatigue
• shortness of breath
• wheezing

If you have symptoms of bronchitis with Entyvio, talk with your doctor. They can recommend ways to ease your symptoms. For example, they may suggest you use a humidifier to ease chest congestion or a cough. Or, they may prescribe certain breathing treatments, such as an inhaler or nebulizer. Examples include albuterol (Proair, Ventolin HFA) and levalbuterol (Xopenex).

Be sure to talk with your doctor about your health history before you start Entyvio. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health.

The conditions and factors to consider include those described below.

Infections. Before starting Entyvio treatment, tell your doctor if you currently have an infection or if you have an infection that keeps coming back. Entyvio may increase your risk of serious infection, including tuberculosis (TB). Be sure your doctor knows whether you have TB now or had it in the past. They may test you for TB before you start Entyvio treatment. If you have TB or another infection, your doctor is likely to treat it before you start this medication. Or, they’ll advise whether a treatment other than Entyvio is a better option for you.

Liver problems. Entyvio may cause liver problems, such as hepatitis (inflammation of the liver). Before starting treatment with Entyvio, tell your doctor if you have any liver problems. The drug may worsen your condition. If you have liver problems, your doctor can advise whether Entyvio is safe for you to receive.

Allergic reaction. If you’ve had an allergic reaction to Entyvio or any of its ingredients, your doctor will likely not prescribe Entyvio. Ask your doctor what other medications may be better options for you.

There isn’t a known interaction between alcohol and Entyvio.

However, alcohol could worsen symptoms of Crohn’s disease and ulcerative colitis. So doctors may advise people with these conditions to avoid alcohol. Because Entyvio is prescribed to treat Crohn’s disease and ulcerative colitis, your doctor may suggest you avoid drinking alcohol during Entyvio treatment.

If you drink alcohol, talk with your doctor. They can recommend how much alcohol may be safe for you to drink while receiving Entyvio.

Below is important information about pregnancy and breastfeeding during Entyvio treatment.

It’s not known for certain whether Entyvio is safe to receive while pregnant. If you’re pregnant or planning a pregnancy, talk with your doctor before starting Entyvio. They can recommend whether Entyvio is the right treatment option for you.

If you receive Entyvio while pregnant, your doctor might advise you to enroll in the drug’s pregnancy registry. Pregnancy registries collect important information about the safety of a drug when received during pregnancy. To learn more, call 877-825-3327, or talk with your doctor.

Entyvio may pass into breast milk. However, it’s not known whether the drug causes side effects in a child who is breastfed. If you’re breastfeeding or planning to do so, talk with your doctor before starting Entyvio. They can discuss the risks and benefits of receiving the drug while breastfeeding.

Talk with your doctor or pharmacist to find out more information about Entyvio. If you have questions about the drug’s side effects, your pharmacist or healthcare professional can help answer them for you.

In addition to discussing Entyvio with your doctor, you may find the following articles helpful in learning more.

• Overview of Entyvio. To read an overview of Entyvio, see this article.
• Drug comparison. To learn how Entyvio compares with Remicade, read this article. And to learn how Entyvio compares with Humira, read this article.
• Details about the conditions Entyvio is prescribed to treat. Learn about Crohn’s disease and ulcerative colitis.

Disclaimer: Healthgrades has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.