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Pregnancy: US Pregnancy category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Lactation: Tacrolimus is distributed into milk. Because of the potential for serious adverse reactions to tacrolimus in nursing infants, nursing should be avoided in women receiving the drug.
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