Esomeprazole

THE SAFETY OF ESOMEPRAZOLE IV (NEXIUM IV) DURING PREGNANCY OR BREASTFEEDING

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.

This medication is considered to have a low risk when used during pregnancy, however it has not been well studied. Omeprazole may be preferred during pregnancy.

What is esomeprazole?

Esomeprazole is a medication known as a proton pump inhibitor (PPI) that reduces gastric acid secretion. It is chemically related to the PPI omeprazole.

What is esomeprazole used to treat?

Esomeprazole is a prescription medication used in adults and children to treat stomach ulcers, duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis, and Helicobacter pylori infection.

How does esomeprazole work?

Esomeprazole is a medication that works to decrease the secretion of gastric acid in the stomach.

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

Animal studies have suggested a possible link between esomeprazole exposure during pregnancy and disturbances in bone development in the baby. Esomeprazole is expected to cross the human placenta to reach the developing baby. Studies have been primarily poor quality, but have not identified a direct link between esomeprazole exposure during the first trimester of pregnancy and an increased risk of birth defects, spontaneous abortion, or preterm delivery. One 2009 study in Sweden identified a possible link between PPI exposure during pregnancy and development of asthma and allergies in infants. One study linked exposure to PPIs in utero to development of hypospadia or misplacement of the urethral opening on the male penis; however, a later study did not find a link between hypospadia and PPI use during pregnancy. Esomeprazole is a newer and less well studied PPI medication, so other PPIs like omeprazole are preferred for use in pregnancy.

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

It is important that you speak with your doctor if you become pregnant while taking esomeprazole. It is recommended that esomeprazole be only be taken during pregnancy if the benefits to the mother outweigh the risks to the developing baby. Accidental exposure to esomeprazole during pregnancy is expected to have low risk of harming a developing baby, although long-term studies are needed.

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

Esomeprazole is expected to pass through human breast milk. The dose of omeprazole expected to be transferred to the infant is 0.9% of the mother’s dose. The effect of esomeprazole exposure on the gastric acid suppression in a nursing infant is unknown. If continuing esomeprazole during breastfeeding, it is important to consider the risks to the infant versus benefits to the mother.

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

There is a lack of information available on the effect of esomeprazole on human fertility. Animals studies have found no impact of the medication on male or female fertility. One 2016 study in males suggests that gastric acid suppression with PPIs can decrease sperm count and quality.

If I am taking esomeprazole, what should I know?

Esomeprazole has limited safety information available in humans. The risk to the infant is unknown. Other PPIs such as omeprazole may be preferred over esomeprazole in pregnant women. It is important to consider the benefits and risks to the mother and baby before using this medication during pregnancy or breastfeeding.

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

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

You may find Pregistry's expert report about proton pump inhibitors here, GERD here, and reports about the various medications used for digestive system disorders here.   Additional information can also be found in the resources below. 

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

U.S. Food and Drug Administration: Nexium IV 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.