Is Consuming Omeprazole in Pregnancy Safe?

Should You Take Omeprazole in Pregnancy?

Medically Reviewed By
Dr. Sanjana Sainani (Gynecologist/Obstetrician)
View more Gynecologist/Obstetrician Our Panel of Experts

Pregnancy is an exciting time for the mother-to-be. However, it is also a time when the mother-to-be needs to take great care to ensure that the unborn baby is safe and developing normally. One of the important things to keep in mind is the use of over-the-counter and prescription medication. Omeprazole is one such medication that is taken by pregnant women for heartburn and acidity.

This article tells you all you need to know about how safe it is to take omeprazole during pregnancy. It also discusses whether omeprazole increases the risk of miscarriages, stillbirths, premature deliveries, and birth defects in the foetus.

What Is Omeprazole?

Omeprazole is both a prescription and over-the-counter medication that is taken by pregnant women for acidity, heartburn, stomach ulcers, and gastroesophageal reflux disease (GERD). Our stomach produces acid to digest food. Overproduction of this acid causes acidity and heartburn. Omeprazole is part of a group of drugs called proton-pump inhibitors (PPIs) that can reduce the production of stomach acid, thus reducing the symptoms of acidity, GERD, and stomach ulcers.

Stomach ulcers are sores in the lining of our stomach caused by bacteria called Heliobacter pylori. Our stomach acids aggravate the pain in these ulcers. This is why omeprazole is prescribed for the treatment of stomach ulcers. GERD is a problem where the sphincter valve of the oesophagus relaxes, and over-production of stomach acid causes reflux of the acid into the oesophagus, resulting in heartburn. Omeprazole is commonly prescribed to alleviate the symptoms of this condition.

Heartburn and gastric trouble in pregnancy

Omeprazole usually comes in the form of delayed-release capsules or powdered forms that are to be mixed in water and taken. It works by turning off the acid-producing proton pumps in the stomach, thereby reducing the quantity of acid made by our stomach.

Is Omeprazole Safe in Pregnancy?

If you are wondering whether you can take omeprazole while pregnant, the answer is yes, but only if the benefit of the drug significantly outweighs the risk to the foetus. Most studies on the efficacy of omeprazole during pregnancy is done on animals, and since there are not many controlled studies on pregnant women, it is advised to use this drug during pregnancy only if clearly needed.

So, can a pregnant woman take omeprazole and not induce complications for the baby? Studies have shown that taking omeprazole does not cause any harm to the unborn baby. However, the effects of exposure to omeprazole on a child’s long-term health have not been well researched. It is, therefore, vital to decide if the benefits of using omeprazole outweigh the possible risks to the foetus.

It is also possible to reduce symptoms of acidity without using drugs. For example, the following can help reduce symptoms of acidity without taking medication – eating smaller meals more frequently, avoiding very spicy and oily food, regularly consuming yoghurt and buttermilk, and raising your pillow so that your head is raised when you lie down.

Lying down with head raised

Are There Any Complications While Using Omeprazole in Pregnancy?

An analysis conducted recently by the FDA revealed a relationship between the use of omeprazole and the risk of cholestasis in pregnant women. Cholestasis is a condition of slow bile flow from the liver, which affects the gallbladder, intestines and pancreas. Therefore, women with weak livers or chronic liver issues should double-check with their doctors before taking omeprazole during pregnancy. It is also important to be watchful because the overdose of omeprazole could cause dry mouth, blurred vision, confusion, headache, and drowsiness.

What If Omeprazole Has Already Been Consumed While Pregnant?

If you have already taken omeprazole while pregnant, let your doctor know. The doctor can analyse whether you still require the medicine and recommend the lowest possible omeprazole pregnancy dosage that is effective in reducing your symptoms. Research has not found any evidence that omeprazole harms the foetus. However, high dosages could still be risky, and it is best to speak to your doctor before taking any medication during pregnancy.

Will Taking Omeprazole During Pregnancy Cause the Baby to Be Born With Birth Defects?

There have been studies that involved examining the foetus of more than 4000 pregnant women that showed that the risk of birth defects in the baby did not increase due to consumption of omeprazole. Other studies have shown that taking omeprazole did not increase the risk of babies being born with cleft lip, heart defects or hypospadias (where the opening of the penis is not on the tip, but on the underside).

However, the main internal organs of the foetus are formed in the first 12 weeks of pregnancy. This is the time when exposure to various medications can cause birth defects. Hence, it is better to avoid taking any medication such as omeprazole during the pregnancy’s first trimester. Consult your doctor before taking omeprazole in the first 12 weeks of pregnancy to avoid unnecessary risk to your unborn baby.

Does Taking Omeprazole in Pregnancy Cause a Miscarriage?

There has been some research that showed that taking omeprazole did not cause an increased risk of miscarriage in pregnant women. Although this is encouraging, a lot more research needs to be done to conclusively prove that omeprazole does not cause miscarriage.

Omeprazole is widely used in pregnant women and is one of the acidity drugs approved for use by mothers-to-be in several countries. It is not known to cause harm to the foetus and is the common medication for acidity and heartburn recommended by doctors.

Does Taking Omeprazole While Pregnant Cause Stillbirth?

Research has shown that taking omeprazole does not increase the risk of having stillbirths. There was a small study that showed that women taking omeprazole were not at a higher risk of having stillborn babies in comparison to women who did not take omeprazole. However, stillbirth rates have not been studied enough in women taking omeprazole to provide conclusive evidence.

Does Consumption of Omeprazole While Pregnant Cause Preterm Birth or Low Birth Weight in the Baby?

As in the case of the studies on stillbirth, there have been 2 studies that researched the risk of having premature babies and babies with low birth weight in women taking omeprazole in pregnancy. One study that examined 1,500 babies exposed to omeprazole as a foetus showed that there was no effect of the drug on their birth weight. Similarly, another study found that in over 450 pregnancies that were studied, there was no evidence of an increased risk of premature delivery in women taking omeprazole. Taking omeprazole in pregnancy third trimester does not increase the incidence of stillbirth.

Despite this encouraging evidence seen from these studies, a lot more research needs to be done, and bigger numbers of pregnant women taking omeprazole need to be studied to conclusively prove that this drug is not harmful to the unborn baby. If you want to take this medicine, you must do so only after checking with your doctor.

Is There Any Risk Involved If the Father Has Consumed Omeprazole?

There has been no evidence of risk to your baby if the father has consumed omeprazole before you became pregnant. Omeprazole has been found to be a safe drug and is commonly prescribed for GERD, acidity, and stomach ulcers.

Omeprazole has been found to be safe for pregnant women and is commonly prescribed for pregnant women experiencing heartburn, GERD or acidity. However, as with any other medication, you need to consult your doctor before taking omeprazole while you are pregnant.

FAQs

1. Does Maternal Exposure to Omeprazole Lead to Later Disorders in Children?

Limited instances are found in recent scientific research. Some studies have indicated a link between pregnant mothers taking acid-suppressing medications and a higher likelihood of their children developing asthma. Since these studies had certain limitations, it’s important to note that other potential factors that might contribute to this outcome could not be definitively excluded.

2. Can Women Who Have a History of Pregnancy Problems Take Omeprazole?

There is little to no evidence suggesting any complications arising in women taking omeprazole who have had a history of pregnancy complications earlier. Therefore, it is best to consult a doctor and take their go-ahead before starting or ending the course of omeprazole during pregnancy.

3. Can I Take Omeprazole While Breastfeeding?

Omeprazole excretes into breast milk at around 300–600 times lower amounts than the doses given to babies. As per a study, if the mother takes 20 mg per day of omeprazole, there is unlikely a chance of adverse effects on the breastfed baby. It is advised to lactating mothers to consult their doctor before consuming omeprazole during breastfeeding.

Omeprazole and pregnancy have a good relationship. Like most prescription medications, omeprazole could have some side effects. Not every person who takes the drug experiences the side effects, but it can interact with other medicines that you may be taking and affect the way they work. Similarly, other medications can also affect the effectiveness of omeprazole. Therefore, it is important to let your doctor know if you are taking any other medication.

References/Resources:

1. Pregnancy, breastfeeding and fertility while taking omeprazole; NHS; https://www.nhs.uk/medicines/omeprazole/pregnancy-breastfeeding-and-fertility-while-taking-omeprazole/

2. Zhang. Y, Shi. D, Abagyan. R, Dai. W, Dong. M; Population Scale Retrospective Analysis Reveals Potential Risk of Cholestasis in Pregnant Women Taking Omeprazole, Lansoprazole, and Amoxicillin; Interdiscip Sci.; PubMed Central; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172024/; June 2019

3. Gerson. L. B; Treatment of Gastroesophageal Reflux Disease During Pregnancy; Gastroenterol Hepatol (N Y), 8(11): 763–764; PubMed Central; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966174/; November 2012

4. Cholestasis; Cleveland Clinic; https://my.clevelandclinic.org/health/diseases/24554-cholestasis.

5. Prilosec (omeprazole) Delayed-Release Capsules and Prilosec (omeprazole magnesium) For Delayed-Release Oral Suspension.; FDA; https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf

6. Omeprazole; medicinesinpregnancy.org; https://www.medicinesinpregnancy.org/Medicine–pregnancy/Omeprazole/

7. Omeprazole Pregnancy and Breastfeeding Warnings; Drugs.com; https://www.drugs.com/pregnancy/omeprazole.html

8. Omeprazole | Esomeprazole; MotherToBaby; https://mothertobaby.org/fact-sheets/omeprazole-esomeprazole/; July 2022

9. Lalkin. A, Loebstein. R, et al.; The safety of omeprazole during pregnancy: A multicenter prospective controlled study; American Journal of Obstetrics and Gynecology, Volume 179, Issue 3, Pages 727-730; ScienceDirect; https://www.sciencedirect.com/science/article/abs/pii/S0002937898700729; September 1998

10. Ali. R. A. R, Hassan. J, Egn. L. J; Review of recent evidence on the management of heartburn in pregnant and breastfeeding women; BMC Gastroenterology; https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02287-w; May 2022

11. Drugs and Lactation Database (LactMed®) [Internet]; Omeprazole; https://www.ncbi.nlm.nih.gov/books/NBK501242/; May 2022

12. Brunner. G, Meyer. H, Athmann. C; Omeprazole for Peptic Ulcer Disease in Pregnancy; Digestion (1998) 59 (6): 651–654; Karger; https://karger.com/dig/article-abstract/59/6/651/104393/Omeprazole-for-Peptic-Ulcer-Disease-in-Pregnancy?redirectedFrom=PDF; November 1998

13. Lai. T, Wu. M, et al. Acid-Suppressive Drug Use During Pregnancy and the Risk of Childhood Asthma: A Meta-analysis; American Academy of Pediatrics Publications; https://publications.aap.org/pediatrics/article-abstract/141/2/e20170889/38059/Acid-Suppressive-Drug-Use-During-Pregnancy-and-the?redirectedFrom=fulltext; February 2018

14. Indigestion and heartburn in pregnancy; NHS; https://www.nhs.uk/pregnancy/related-conditions/common-symptoms/indigestion-and-heartburn/

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