Lactulose has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Lactulose should only be given during pregnancy when need has been clearly established.

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There are no data on the excretion of lactulose into human milk. While the manufacturer recommends cautious use during lactation, adverse effects in the nursing infant are unlikely given the pharmacology and pharmacokinetics of the drug.

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