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Pregnancy: Omeprazole cross the placenta in animals and humans. Because there are no adequate and controlled studies using omeprazole in pregnant women and because studies to date in animals and pregnant women cannot rule out the possibility of harm, the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus.
Lactation: Omeprazole is distributed into human milk. Because of the potential for serious adverse reactions to omeprazole in nursing infants and because of the potential for tumorigenicity shown in animal studies, a decision should be made whether to discontinue nursing or the drug taking account the importance of the drug to the women.
