Prilosec and Pregnancy

In animal studies that looked at pregnancy and Prilosec, the drug increased the risk of miscarriages when given in high doses to pregnant rabbits. Therefore, the FDA has classified it as a pregnancy Category C drug, which means Prilosec may not be safe to take during pregnancy. However, other studies have suggested that the medicine may be safe for use in pregnant women.

Is Prilosec Safe During Pregnancy?

Prilosec® (omeprazole) is generally not considered safe for women who are pregnant. In animal studies that looked at the effects of Prilosec on pregnancy, the drug increased the risk of miscarriages. Studies that exposed pregnant rats to esomeprazole, a constituent of Prilosec, found developmental problems in the offspring and bone abnormalities in both mothers and pups.

Prilosec and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been adequately studied in pregnant women or animals are automatically given a pregnancy Category C rating.
Esomeprazole is an isomer of omeprazole, which is found in Prilosec. When esomeprazole was given to pregnant rats at high doses, fewer offspring survived after birth. The surviving pups had developmental delays, abnormal bone growth, and poor weight.
Pregnant and nursing rats that were given high doses of esomeprazole lost bone mass, which is consistent with the possible effects of the drug on calcium absorption (it can decrease calcium absorption).
When given to pregnant rabbits at high doses, Prilosec increased the risk of miscarriages. However, various observational studies suggest that the medication may be safe for use in pregnant women.
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