If you have a certain type of inflammatory bowel disease (IBD), your doctor might suggest Entyvio (vedolizumab) as a treatment option for you. Along with other questions you may have about the drug, you could be wondering about its side effects.
Entyvio is a prescription medication that’s used to treat the following types of IBD in adults:
These conditions are autoimmune diseases, which means that your immune system attacks your body and causes inflammation to occur. You may wonder what Entyvio does to your body to treat your symptoms. It reduces your symptoms of Crohn’s disease or ulcerative colitis by decreasing inflammation.
Entyvio is available as a solution that a healthcare professional injects into your vein over about 30 minutes. Entyvio is a biologic drug, which means that it’s made from living cells. If this medication works for you, your doctor will likely recommend that you use it long term.
For more information about Entyvio, see this in-depth article on the drug.
Like other drugs, Entyvio can cause mild or serious side effects. Keep reading to learn more.
Some people may have mild or serious side effects during Entyvio treatment. Examples of Entyvio’s commonly reported side effects include:
Examples of mild side effects that have been reported with Entyvio include:
- itchy skin and rash*
- joint pain*
- infections, such as a cold or respiratory infection
- fatigue (lack of energy)
- back pain
- mouth pain
- pain in your arms or legs
* To learn more about this side effect, see “Side effects explained” below.
In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop using Entyvio unless your doctor recommends it.
The list above doesn’t include all side effects of Entyvio. See the Entyvio medication guide for details.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Entyvio, visit MedWatch.
Serious side effects that have been reported with Entyvio include:
- progressive multifocal leukoencephalopathy, a serious brain infection*
- allergic reaction*
- infusion-related reactions
- liver problems*
* To learn more about this side effect, see “Side effects explained” below.
If you develop serious side effects during Entyvio treatment, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Get answers to some frequently asked questions about Entyvio’s side effects.
How long do Entyvio’s side effects last? Are any side effects long term?
It varies. How long Entyvio’s side effects last depends on what side effects you’re experiencing. 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 be long term.
Talk with your doctor about your risk of developing long-term side effects. They might monitor you for symptoms of side effects that could be long term. As a result, your doctor may be able to treat these side effects earlier.
If you do develop side effects that are bothersome to you, talk with your doctor. They can suggest ways to treat the side effects or recommend other medications to treat your condition.
Can Entyvio cause hair loss or weight gain?
Other medications that can be used to treat ulcerative colitis or Crohn’s disease may cause hair loss or weight gain. For example, prednisone can be used to treat flare-ups of either of these conditions. This drug can cause both hair loss and weight gain.
If you have hair loss or weight gain while receiving Entyvio, talk with your doctor. They’ll try to determine the cause. They may also recommend ways to decrease the side effect.
Is anxiety one of Entyvio’s side effects?
But it’s possible that you may develop anxiety relating to your Crohn’s disease or ulcerative colitis. There is
If you have anxiety during Entyvio treatment, talk with your doctor. They can help determine what may be causing it and the best way to treat it.
How do Entyvio’s side effects compare with Humira’s?
Entyvio and Humira are both medications used to treat ulcerative colitis and Crohn’s disease. The drugs work differently in your body to treat these conditions. As a result, these medications have some similar and some different side effects.
Both Entyvio and Humira can cause mild side effects, such as:
- back pain
In addition, Entyvio may also cause fatigue (lack of energy), cough, and mouth, arm, or leg pain.
Injection site reactions are common with Humira. These may include symptoms such as itching, pain, and swelling in the area of the injection.
Serious side effects, such as allergic reaction and liver problems, are possible with both Entyvio and Humira.
Entyvio can cause progressive multifocal leukoencephalopathy (PML), which is a serious and possibly life threatening infection. While Humira doesn’t cause PML, other neurological (nerve-related) side effects can occur with this drug. An example is multiple sclerosis.
If you’re interested in learning more about how Entyvio compares with Humira, talk with your doctor. They can discuss which drug may be better for you based on your medical conditions and other medications you take.
Can Entyvio cause eye-related side effects?
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 (PML). PML 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, changes in personality or memory, and confusion.
In addition, liver problems can occur with Entyvio. A symptom of liver disease is 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 do some 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, a serious brain infection
Although rare, it’s possible to develop progressive multifocal leukoencephalopathy (PML) from Entyvio. This condition is a serious, potentially life threatening infection that affects your brain.
Even though PML is very rare, you should be aware of its possible symptoms. This way, if you develop symptoms of PML, you can let your doctor know right away. Symptoms include:
- neurological (nerve-related) side effects, such as confusion or changes in the way that you talk
- balance problems
- blurry vision
- loss of vision
What might help
Throughout your Entyvio treatment, your doctor will watch for symptoms of PML. If you develop any symptoms of this condition, go to the hospital or contact your doctor right away. They’ll offer care for PML and recommend that you stop receiving Entyvio.
If you have additional questions about the possibility of PML occurring from Entyvio, talk with your doctor.
Itchy skin and rash
Entyvio can cause itchy skin or a rash. These are common side effects of the drug.
What might help
If you develop itchy skin or a rash during Entyvio treatment, you should contact your doctor. In rare cases, a rash can be a sign of an allergic reaction or an infusion-related reaction.
Your doctor will determine if the rash is serious and whether it needs treatment. If it does need treatment, they can recommend a cream or medication to soothe your itchy skin or rash.
You may have joint pain from Entyvio. Joint pain was one of the most common side effects reported in people receiving Entyvio.
What might help
If you have joint pain from Entyvio, tell your doctor. They may be able to recommend over-the-counter medications, such as Tylenol (acetaminophen), or other treatment options for this side effect.
If you’re concerned about developing joint pain from Entyvio, talk with your doctor or pharmacist.
Entyvio may cause liver problems. Some people who received this medication have had increased liver enzymes, which may indicate liver damage. Although this side effect is rare, it can be very serious or even life threatening.
You should watch for symptoms of liver problems while you’re receiving Entyvio. If you develop any, report them to your doctor right away. Symptoms of liver problems include:
- yellowing of the eyes or skin
- belly pain
What might help
If you develop any symptoms of liver problems while receiving Entyvio, tell your doctor right away. They can order blood tests to determine whether there is an issue with your liver. If there is, they’ll work with you to come up with the best treatment plan for you. They may also recommend that you stop receiving Entyvio.
Like most drugs, Entyvio can cause an allergic reaction in some people.
Symptoms can be mild or serious and can include:
- skin rash
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. To manage your symptoms, they may suggest an over-the-counter antihistamine that you take by mouth, such as Benadryl (diphenhydramine). Or they may recommend a product that you apply to your skin, such as hydrocortisone cream.
If your doctor confirms that you had a mild allergic reaction to Entyvio, they’ll decide if you should continue using it.
If you have symptoms of a severe allergic reaction, such as swelling or trouble 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 that you had a serious allergic reaction to Entyvio, they may have you switch to a different treatment.
Keeping track of side effects
During your Entyvio treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.
Your side effect notes can include things such as:
- what dose of drug you were taking when you had the side effect
- how soon after starting that dose you had the side effect
- what your symptoms were from the side effect
- how it affected your daily activities
- what other medications you were also taking
- any other information you feel is important
Keeping notes and sharing them with your doctor will help your doctor learn more about how Entyvio affects you. And your doctor can use this information to adjust your treatment plan if needed.
Entyvio may not be right for you if you have certain medical conditions or other factors that affect your health. Before you start Entyvio treatment, talk with your doctor about your health history. The list below includes factors to consider.
Active infections or tuberculosis (TB). If you have an active infection or have had TB, tell your doctor before you receive Entyvio. This medication can increase your risk of infection and decrease your body’s ability to fight off an infection. Before you start Entyvio treatment, your doctor will likely treat any infection you have. They’ll also give you a test for TB to make sure you don’t have it.
Allergic reaction. If you’ve had an allergic reaction to Entyvio or any of its ingredients, you shouldn’t receive Entyvio. Ask your doctor what other medications are better options for you.
Liver conditions. It’s possible that Entyvio can cause liver problems. If you already have a liver condition, receiving Entyvio can make your liver condition worse. Before you start Entyvio treatment, tell your doctor about any liver conditions that you have. They’ll be able to find out if Entyvio is a safe option for you.
Alcohol use and Entyvio
There are no known interactions between Entyvio and alcohol. But some of the side effects of Entyvio may become worse with alcohol consumption. For example, both alcohol and Entyvio can cause:
- liver problems
Since both Entyvio and alcohol cause these symptoms, drinking alcohol during Entyvio treatment may make such side effects even worse.
Pregnancy and breastfeeding while receiving Entyvio
It’s not known if Entyvio may be safe to receive during pregnancy.
If you do become pregnant while receiving Entyvio, consider signing up for a pregnancy registry. This registry is a collection of data taken from pregnant people who have used Entyvio. This data can help determine whether the drug may be safe to use or what side effects it might cause during pregnancy. You can sign up for the registry by calling 877-TAKEDA7 (877-825-3327).
If you’re pregnant or planning to become pregnant, talk with your doctor about treatment options that are right for you.
Entyvio is present in breast milk, so a child breastfed by someone receiving the drug would be exposed to it. But it isn’t known what effects Entyvio may have on a breastfed child. If you’re breastfeeding or planning to breastfeed, talk with your doctor about safe ways to feed your child during Entyvio treatment.
Most often, side effects from Entyvio are mild and manageable. But sometimes Entyvio may cause serious side effects. Before starting Entyvio treatment, you should discuss your risk of side effects with your doctor. Here are some questions to get your conversation started:
- What side effects am I at highest risk of based on my medications and other medical conditions?
- What happens if I become pregnant during Entyvio treatment?
- How can I best manage side effects that I have from Entyvio?
Disclaimer: Healthline 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.