7 Entyvio Side Effects You Should Know About

Millions of U.S. adults live, work with, and manage inflammatory bowel disease (IBD) every day. IBD is a term that mainly describes two inflammatory gastrointestinal (GI) conditions: Crohn’s disease (CD) and ulcerative colitis (UC).

It’s unclear what the exact cause of IBD is. But it’s thought to be due to the immune system overreacting to triggers along the GI tract — causing excess inflammation. This can lead to stiff abdominal pain and frequent diarrhea, among other symptoms. Medications are often required to help get these symptoms under control. But sometimes it takes some trial and error to find a medication that’s effective and tolerable for you.

In this article, we’ll talk about a specific medication used to treat IBD — Entyvio (vedolizumab). We’ll also highlight seven noteworthy Entyvio side effects and how to manage them.

What is Entyvio?

Entyvio is FDA-approved to treat moderate to severe CD and UC. It’s a type of biologic medication. Biologics are complex medications that come from natural or living sources instead of chemicals. They’re often used to manage hard-to-treat health conditions.

Entyvio is given through a vein once every 8 weeks (2 months). It’s an IV infusion that’s usually given at a hospital, clinic, or infusion center. Each infusion takes about 30 minutes to complete.

Is Entyvio a high-risk medication?

Potentially. Some people consider Entyvio to be a high-risk medication, but this isn’t an official description. That’s because it may contribute to rare but serious effects among people who take it. Some of the top risks are highlighted below.

Good to know: Entyvio doesn’t have any boxed warnings. This is the most serious medication warning that the FDA can assign to a medication. It’s reserved for especially risky medications.

1. Mild to moderate infection

Entyvio treats IBD by lowering inflammation in the GI tract. It does this by calming your immune system. This helps improve IBD symptoms, but it can also put people at a higher risk of infection.

Fortunately, most infections aren’t serious. The most common type of infection reported is the common cold (nasopharyngitis). This is also the most common side effect of Entyvio overall. Roughly 1 out of every 8 people experienced nasopharyngitis in Entyvio’s initial studies. Other types of common infections include:

• Upper respiratory tract infections

• Sinus infections

• Bronchitis

• Flu

You can potentially manage some infections, like the common cold, by yourself. But for more serious infections, it is a good idea to reach out to your healthcare provider.

2. Cold and flu symptoms, like a headache

It’s relatively common to develop symptoms that resemble the common cold or flu while receiving Entyvio. These may or may not be tied to an infection.

Headache is one common complaint. In fact, more than 1 out of every 9 people experience a headache with Entyvio. Other flu-like symptoms that are possible include:

• Nausea

• Fever

• Tiredness

• Cough

If you’re feeling under the weather before your Entyvio infusion, make sure to let your healthcare provider know. They may want to delay your infusion until you feel better. In the meantime, they’ll likely recommend ways to manage cold or flu symptoms you’re experiencing.

3. Body pain

In Entyvio’s initial studies, about 12% of people reported feeling pain in their joints. Some people also had pain in their back, arms, and legs. However, these types of pain were less common.

The reason Entyvio may cause body pain is unclear. But joint pain is a known complication of IBD. This may be linked to the gut inflammation that people living with IBD experience. In fact, according to one study, the risk of joint pain from Entyvio is no higher than with other treatments, like TNF blockers.

Pain relievers like acetaminophen and NSAIDs like ibuprofen (Advil, Motrin) may be helpful in relieving headaches, back, and joint pain. Make sure to ask your healthcare provider if taking these medications would be appropriate.

4. Infusion reactions

Infusion reactions are possible with IV medications like Entyvio. They can occur any time you receive it; they can appear while you get the infusion or several hours afterwards. Infusion-related side effects can get worse for a couple days before they start to get better. Some of the most common symptoms are itching, redness, and swelling near the infusion site.

If you develop symptoms of an infusion reaction (or an allergic reaction) while you’re still receiving your infusion, make sure to alert your care team. They can manage the reaction by lowering how fast Entyvio is given. They may also give you medications to control pain or itching, like acetaminophen (Tylenol) or diphenhydramine (Benadryl).

If you’ve already left your treatment center, seek medical help if you experience hives, trouble breathing, or you feel like your heart is racing. This might be a sign of anaphylaxis, a serious allergic reaction.

5. Serious infection

If Entyvio causes an infection, it’s usually not that serious. But serious infections, such as tuberculosis (TB) and sepsis, can occur in rare cases. Your healthcare provider will likely test you for TB prior to starting Entyvio as a precaution.

In very rare cases, Entyvio can lead to a viral infection in the brain. This is called progressive multifocal leukoencephalopathy (PML). People who already have a weak immune system are at higher risk of PML.

For most people, the virus that causes this condition is nothing to worry about. It might not even cause symptoms. But for people with PML, the infection damages the coating that protects nerves in the brain. This can make it hard to control your body movements and it can cause memory problems. Ultimately, the infection can lead to severe disability and be life threatening.

Your healthcare provider will likely pause or stop your Entyvio treatment if you develop a severe infection of any type.

6. Liver damage

There are rare reports of people experiencing liver damage from Entyvio. It’s unclear why Entyvio does this.

Your healthcare provider may ask you to complete blood tests before and during treatment with Entyvio to monitor your liver health. They may also check to make sure you don’t have signs of hepatitis B infection. There’s a risk that Entyvio could worsen problems associated with this condition.

7. Pancreas inflammation

Inflammation of the pancreas, or pancreatitis, is another possible Entyvio side effect. Experts aren’t sure why it happens, but there have only been a handful of reports of pancreatitis in people who take it. This side effect can cause clammy skin, stomach pain, and difficulty eating.

Talk to your healthcare provider if you think you’re experiencing symptoms of pancreatitis. It’s important to manage pancreatitis quickly and try to prevent it from becoming a chronic issue.

What can I do to prevent the side effects of Entyvio?

Preventing infection should be top of mind while you’re taking Entyvio. 

Some infections can be prevented by getting vaccinated. People should be up to date with their vaccines before starting Entyvio. People already getting Entyvio can get the yearly flu shot. But they should talk to their healthcare provider before considering the intranasal flu vaccine. This is because the nasal spray is a “live vaccine.” It contains a weakened form of the flu virus. People with weakened immune systems may be at higher risk for developing an infection after receiving a live vaccine.

Other common live vaccines you should avoid while receiving Entyvio include the following:

• Measles, mumps, rubella (MMR II)

• Varicella (Varivax) — the chickenpox vaccine

• Yellow fever vaccine (YF-Vax)

Otherwise, your healthcare provider may give you medications — such as acetaminophen, diphenhydramine, or a corticosteroid — before your Entyvio infusions. These help prevent or lessen infusion reactions.

When should I contact my healthcare provider about side effects from Entyvio?

More serious side effects warrant medical advice in some capacity. It’s important to let your healthcare provider know if you develop signs or symptoms of a more serious infection. This includes:

• A lasting fever

• Chills

• Shortness of breath

• Sores on the skin

• Pain while urinating

Allergic reactions from Entyvio can be life-threatening. Seek immediate medical attention if you notice signs of anaphylaxis during or after you receive your infusion. Symptoms may include:

• Shortness of breath

• Wheezing

• Throat tightness

• Hives

• An irregular heartbeat

Why trust our experts?

Written by:

Nathan Williams, PharmD, RYT

Nathan is a clinical pharmacist, certified yoga instructor, and medical content writer. His clinical practice has spanned several sub-specialties including: emergency medicine, nutrition, and pediatrics.

Edited by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Stacia Woodcock, PharmD

Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.

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