An individual undergoing IV infusion.

Approximately 3.1 million adults in the U.S. live with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease. As biologic therapies become more common in treatment plans, understanding the potential side effects of these medications is essential for safe, informed care.

Entyvio (vedolizumab) is a gut-selective biologic approved for moderate to severe UC and Crohn’s. Its targeted mechanism helps reduce inflammation without broadly suppressing the immune system, lowering the risk of some systemic side effects compared to other biologics.

In this article, we’ll explore the side effect profile of Entyvio, covering common, uncommon, and rare reactions, as well as what patients should watch for during treatment.

Key Takeaways

  • Entyvio is a biologic therapy approved for moderate to severe ulcerative colitis and Crohn’s disease, offering targeted inflammation control with a favorable safety profile.
  • Common side effects include cold-like symptoms, headaches, joint pain, nausea, and fever, which are typically mild and temporary.
  • Serious adverse reactions—such as infusion reactions, infections, liver problems, and rare neurological events like PML—are rare but require immediate medical attention.
  • Side effects may differ slightly between ulcerative colitis and Crohn’s disease patients, making individualized care and monitoring essential.
  • Patients should be counseled on how long Entyvio takes to work (around six weeks for many) and the importance of promptly reporting new or worsening symptoms.
  • Regular follow-ups, lab monitoring, and personalized treatment adjustments help maximize benefits and minimize risks during Entyvio therapy.

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Common Side Effects of Entyvio

An individual dealing with symptoms, like fever, headache, and colds.

Entyvio has received FDA approval as an integrin receptor antagonist to treat moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). While it is known for its favorable safety profile, patients should be made aware of common side effects to make informed treatment decisions.

According to clinical trials, the most frequently reported Entyvio side effects include:

  • Cold-like symptoms (13% vs. 7% in placebo)
  • Headaches (12% vs. 11%)
  • Joint pain (12% vs. 10%)
  • Nausea (9% vs. 8%)
  • Fever (9% vs. 7%)

These symptoms are generally mild and self-limiting, resolving within a few days. Patients should seek medical attention if symptoms persist or worsen.

Serious Adverse Reactions and Warnings

An individual with allergy, scratching their itchy neck.

Despite its clinical benefits and FDA approval, Entyvio can cause rare but serious side effects, especially if administered improperly or used in patients with certain contraindications.

These may include:

  • Infusion-related and allergic reactions: Symptoms may involve rash, swelling, difficulty breathing, or fast heartbeat.
  • Serious infections: Increased risk of respiratory or urinary tract infections, often indicated by fever, chills, or persistent cough.
  • Progressive Multifocal Leukoencephalopathy (PML): A rare brain infection caused by the JC virus. Watch for signs like confusion, vision changes, or weakness.
  • Liver complications: Look out for jaundice, abdominal pain, or unusual fatigue.

Prompt recognition and urgent medical evaluation are critical for managing these risks.

Differences in Side Effects Between Ulcerative Colitis and Crohn’s Disease Patients

Ulcerative colitis and Crohn’s disease are both types of inflammatory bowel disease, but they differ in location and behavior—which can affect the clinical experience of Entyvio treatment.

  • Ulcerative Colitis: Affects only the large intestine with continuous areas of inflammation. Patients often report rectal bleeding and urgency.
  • Crohn’s Disease: Can involve any part of the digestive tract, from mouth to anus, often with patchy areas of inflammation and a broader range of symptoms.

While Entyvio’s safety profile is generally consistent across both groups, the symptom patterns and perceived side effects may vary. This highlights the importance of personalized care and ongoing communication with healthcare providers.

Management and Monitoring of Side Effects

Patients using Entyvio for Crohn’s disease or ulcerative colitis benefit most from proactive monitoring and tailored support. Strategies include:

  • Routine checkups and lab work to identify side effects early.
  • Therapy adjustments to optimize benefits and reduce adverse reactions.
  • Multidisciplinary care involving specialists for tailored, holistic treatment.

Healthcare professionals must work closely with patients to track response, adjust plans, and manage any complications efficiently.

Patient Counseling and Reporting Adverse Events

A doctor and patient consultation.

Patients commonly ask: How long does Entyvio take to work?” While individual responses vary, many patients start seeing improvement around six weeks into therapy.

To enhance safety and adherence:

  • Educate patients about both common and serious Entyvio side effects.
  • Encourage open communication about symptoms, discomfort, or concerns.
  • Use clear reporting channels such as patient portals, helplines, or direct provider access to log adverse events.

This collaborative approach ensures early intervention and improves patient confidence in their treatment journey.

Conclusion

Entyvio offers an effective, gut-selective treatment option for managing moderate to severe ulcerative colitis and Crohn’s disease. While its side effect profile is generally mild, being aware of possible risks—from headaches and joint pain to serious infections or allergic reactions—empowers both patients and providers to respond appropriately.

By fostering ongoing communication, applying clinical monitoring protocols, and ensuring individualized care, Entyvio can contribute to improved quality of life for patients managing chronic IBD.

FAQs

1. What are the common side effects of Entyvio?

Common side effects include cold-like symptoms, headaches, joint pain, nausea, and fever. Most of these are mild and typically resolve within a few days to a week.

2. Are there serious risks associated with taking Entyvio?

Yes, while Entyvio is generally safe, there are risks of serious side effects, such as infusion-related reactions, increased infection risk, progressive multifocal leukoencephalopathy, and liver problems. It’s essential to seek immediate medical attention if these symptoms occur.

3. How do ulcerative colitis and Crohn’s disease differ about Entyvio?

While both conditions affect the digestive system, their location and symptoms differ. Ulcerative colitis primarily affects the large intestine with continuous inflammation, while Crohn’s disease can affect any part of the digestive tract, sometimes leading to different side effects and treatment considerations.

4. What should I expect during an Entyvio infusion?

Some patients may experience infusion-related reactions such as chills, fever, rash, or breathing difficulties. These usually occur during or shortly after the infusion and should be reported immediately to your healthcare provider.

5. How will my doctor monitor me while I’m on Entyvio?

Your doctor will regularly check for infections, liver function, and neurological symptoms through blood tests and clinical evaluations to ensure your safety during treatment.

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References

  1. Centers for Disease Control and Prevention. (n.d.). IBD Facts and Stats. Www.cdc.gov. Retrieved April 11, 2025, from https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html
  2. WebMD Editorial Contributors. (n.d.). Crohn’s & Ulcerative Colitis: Know the Difference? WebMD. Retrieved April 14, 2025, from https://www.webmd.com/ibd-crohns-disease/crohns-colitis-difference#1-1