Animal models have revealed evidence of changes to crown-rump length, male-only growth plate thickness, femur bone length and weight, and reduced body weight gain when given during organogenesis through lactation at doses 1.8 times the maximum recommended human dose. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comment: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

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A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (lansoprazole)

Comment: The effects in the nursing infant are unknown.

No information is available regarding use during breastfeeding or the effects on milk production.

See references