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THE SAFETY OF OMEPRAZOLE (PRILOSEC) 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.

What is omeprazole?

Omeprazole is a medication known as a proton pump inhibitor (PPI) that reduces gastric acid secretion.

What is omeprazole used to treat?

Omeprazole is a prescription medication used to treat stomach ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD) in adults and children, and conditions that cause excess secretion of gastric acid.

How does omeprazole work?

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

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

Studies have been primarily poor quality and have failed to identify a direct link between omeprazole exposure and an increased risk of birth defects such as heart defects. One 2009 study in Sweden identified a possible link between omeprazole exposure during pregnancy and development of asthma and allergies in infants. One study linked exposure to omeprazole in utero to development of hypospadia or misplacement of the urethra opening on the male penis; however, a later study did not find a link between hypospadia and omeprazole use during pregnancy. The impact of maternal omeprazole exposure on infant gastric acid production is unknown and requires further study.

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

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

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

Omeprazole passes through human breast milk. The dose of omeprazole expected to be transferred to the infant is 0.2% to 0.43% of the mother’s dose. It is recommended that you discontinue this medication while breastfeeding. If continuing omeprazole during breastfeeding, it is important to consider the risks and benefits to the infant versus benefits to the mother.

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

There is a lack of information available on the effect of omeprazole on human fertility. Animals studies have found no impact of the medication on male or female fertility.

If I am taking omeprazole, what should I know?

Omeprazole has limited safety information available in humans. The risk to the infant is expected to be low; however, this medication 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 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 omeprazole 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: Prilosec Prescribing Information

Read the whole report
Last Updated: 22-03-2019
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.