The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.


Available information on use during pregnancy is limited.

What is vedolizumab?

Vedolizumab is a medication that decreases inflammatory activity in the body, specifically in the human gut.

What is vedolizumab used to treat?

Vedolizumab is a prescription medication used to treat Crohn’s disease and ulcerative colitis in adults.

How does vedolizumab work?

Vedolizumab is an antibody that decreases the presence of inflammatory chemicals in the body that contribute to diseases such as Crohn’s disease and ulcerative colitis.

If I am taking vedolizumab, can it harm my baby?

Safety data in pregnant humans is lacking. Although vedolizumab has not produced adverse effects in animal studies, any adverse effects would be most likely to result while taking the medication during the second and third trimesters. One study in pregnant women exposed to vedolizumab suggested a potential increase in infection risk.

If I am taking vedolizumab and become pregnant, what should I do?

The risks to the infant should be weighed against the benefits to the mother before continuing vedolizumab therapy during pregnancy. Women on vedolizumab therapy during pregnancy are encouraged to enroll in the Vedolizumab Pregnancy Registry.

If I am taking vedolizumab, can I safely breastfeed my baby?

The effect of vedolizumab on breastfeeding infants is unknown. It is important to be cautious when administering vedolizumab while breastfeeding.

If I am taking vedolizumab, will it be more difficult to get pregnant?

Animal studies have reported no effect of vedolizumab therapy on male or female fertility.

If I am taking vedolizumab, what should I know?

It is important to speak with your doctor to determine if you should continue vedolizumab therapy during pregnancy. Information on use of vedolizumab therapy during pregnancy is limited. Vedolizumab should only be used during pregnancy if the benefit to the mother outweighs the risk to the developing baby.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of vedolizumab during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about autoimmune diseases here, and reports about the individual medications used to treat immune disorders here. Additional information can also be found in the resources below. 

For more information about vedolizumab during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Takeda Pharmaceuticals: Entyvio Prescribing Information

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.