Omeprazole is a medication grouped under the class of drugs named proton pump inhibitor (PPI) and is indicated for the treatment of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) in adults and children. It is also used for duodenal ulcers in combination with clarithromycin and amoxicillin in patients with Helicobacter pylori infection. Other conditions include gastric, erosive esophagitisiXA severe form of GERD where the reflux of stomach acids damages the esophageal lining. , and disorders of stomach acid hypersecretion such as Zollinger Ellison syndromeiXA serious condition characterized by increased production of gastrin hormone due to small tumors in the pancreas or small intestine. and multiple endocrine tumors (1).
This post discusses the use of omeprazole during pregnancy and whether it is safe for pregnant women and the growing fetus.
Why Is Omeprazole Prescribed During Pregnancy?
Heartburn is a common problem affecting about 30-50% of pregnant women. The condition causes discomfort and increases the incidences of nausea and vomiting (2). The hormone progesteroneiXA female hormone responsible for menstruation and pregnancy. increases during pregnancy and causes muscles between your stomach and esophagus to relax, resulting in acid reflux.
Additionally, the growing baby presses on the stomach, making heartburn common during late pregnancy (after 27 weeks). Medications are required to relieve the symptoms when dietary or lifestyle changes are not effective enough. Omeprazole is one such medication prescribed during pregnancy as it decreases the amount of acid produced by the stomach (3) (4).
Is Omeprazole Safe In Pregnancy?
Consuming Omeprazole while pregnant is generally considered safe, but it is advisable to consult with your doctor to avoid any potential adverse effects (3) (5). The US Food and Drug Administration (FDA) initially listed omeprazole as a Pregnancy Category C drug (showed risk in animal studies but data from human studies are inconclusive).
Studies in animals and multiple cohort studies in pregnant women did not show an increase in the risk of adverse outcomes during pregnancy. However, as sufficient well-controlled studies are not available on the use of omeprazole in pregnant women, the FDA presently recommends that the drug should be used only if clearly needed during pregnancy. Thus, the medicine should be limited to cases where the benefits outweigh any risk (1).
Are There Any Pregnancy Complications Associated With Omeprazole Use?
A recent analysis of data from FDA Adverse Event Reporting System (FAERS) has shown a relationship between omeprazole use and the risk of cholestasis in pregnant women. Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder where bile flow from the liver is obstructed. According to the American Liver Foundation, one to two out of 1000 pregnancies are affected by ICP, in the US. Typical symptoms include intense itching, dark urine, and abnormal liver function tests. However, extensive research is required to conclude any definite connection between omeprazole and ICP. Women with existing or chronic liver problems should be extra cautious before taking omeprazole.
Does Omeprazole Cause Birth Defects?
Every pregnancy has a certain baseline risk of birth defects, and a drug is judged based on whether it increases this risk percentage. Multiple studies demonstrate the safety of omeprazole during pregnancy. A study on 113 pregnant women exposed to omeprazole did not show any increased risk of birth defects (6).
A large study from Denmark (840,000 births) could not establish any significant link between PPI usage in the first trimester of pregnancy and birth defects (7) (8). When tested in rats and rabbits, omeprazole at doses corresponding to 5.6 to 56 times higher than in humans showed loss of fetus and pregnancy complications (9). These findings may indicate that the prescribed doses of omeprazole are unlikely to cause any adverse effects on maternal health.
Does Taking Omeprazole In Pregnancy Cause A Miscarriage?
Studies reveal no additional risk of spontaneous abortion (miscarriage) with omeprazole use. A meta-analysis of published studies using data of 1530 pregnant women exposed to omeprazole found no association with drug use and miscarriage (10).
Does Omeprazole Cause Stillbirth, Preterm Birth, Or Low Birth Weight?
The information available from research to date does not show any teratogenic consequences, such as the added risk of stillbirth, preterm birth, or low birth weight, due to omeprazole use during pregnancy (11). According to a recent systematic review, the association of stillbirths or other adverse fetal developmental outcomes with PPI usage in pregnant women was not significant (12).
Can Maternal Exposure To Omeprazole Cause Any Disorder In The Child Later?
Limited incidences are present in current scientific literature. A few studies have shown an association of exposure of pregnant mothers to acid-suppressing drugs with increased risk of childhood asthma in the child. The studies had limitations, and the role of other causative factors could not be ruled out (13) (14) (15).
Can Breastfeeding Mothers Take Omeprazole?
Omeprazole is secreted in breast milk, but if the mother takes 20mg per day, the levels present in milk are unlikely to cause any adverse effects in the baby. Safer drugs include antacids, histamineiXA chemical produced by the immune system in response to allergic reactions. H2 blockers (famotidine), pantoprazole, and sucralfate. However, you should consult your doctor before starting omeprazole (16).
The short-term use of omeprazole in pregnancy is considered safe only after a doctor specializing in obstetrics and gynecology recommends it. Medications such as omeprazole fall under the category of proton-pump inhibitors, which are used as a last resort treatment option for GERD during pregnancy. One should not use omeprazole for an extended period during pregnancy as it is reportedly linked with deficiencies of vitamins (B12 and C) and minerals (magnesium, calcium, and iron). Another side effect of the long-term use of such medications is the increased risk of UTIs and intestinal and respiratory infections (17). Thus, it is advised to take these medications cautiously.
Frequently Asked Questions
1. What happens if I take omeprazole every day?
Taking omeprazole as part of prenatal care for a short duration usually doesn’t cause any major issues. The drug may cause mild side effects such as headache, flatulence, and constipation. Long-term use may increase the risk of gut infection, bone fractures, and vitamin B12 deficiency (18). Speak to your doctor if you have concerns about the long-term use of the drug.
2. Can omeprazole cause irregular heartbeat?
Long-term use of omeprazole for about three months or more may cause a drop in magnesium levels in the blood. Low magnesium can cause an irregular heartbeat (18).
3. Can omeprazole be used in women who have a history of complications during pregnancy?
No scientific evidence suggests that omeprazole causes any harm to the mother or the baby if the mother has a history of complications. However, it is best to consult a healthcare provider before using or discontinuing a medicine.
Infographic: Additional Information On Using Omeprazole During Pregnancy
Acid reflux or heartburn is common during pregnancy and may require medications if the discomfort is not relieved with home remedies. If you have been prescribed omeprazole during pregnancy, there are some important points to keep in mind. Check out this infographic below for some more helpful information about omeprazole.
- Administering omeprazole during pregnancy reduces the amount of acid produced by the stomach.
- US FDA recommends the medication to expectant mothers only if needed.
- Omeprazole doesn’t cause any congenital disabilities or miscarriage.
- Lactating mothers can take around 20mg of this drug per day.
- Analysis by FAERS shows a link between omeprazole and the risk of cholestasis in pregnant women.
In this informative video, learn more about the adequate dosage and potential side effects of using omeprazole and make safe and informed health choices.
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- I Matok et al. The safety of fetal exposure to proton-pump inhibitors during pregnancy.
- Cheng Mei Li et al.; (2020); Systematic review with meta-analysis: the risks of proton pump inhibitors during pregnancy.
- Yonghong Zhang et al. (2019), Population Scale Retrospective Analysis Reveals Potential Risk of Cholestasis in Pregnant Women Taking Omeprazole
- MaayanYitshak-Sade et al.; Prenatal exposure to H2 blockers and to proton pump inhibitors and asthma development in offspring.
- Tianwen Lai et al. Acid-Suppressive Drug Use During Pregnancy and the Risk of Childhood Asthma: A Meta-analysis.
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- ArunKoyyada; (2021); Long-term use of proton pump inhibitors as a risk factor for various adverse manifestations.
- Side effects of omeprazole.