Gadoxetate has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Gadoxetate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Based on pharmacokinetics of gadoxetate, women with normal renal function may resume nursing with milk produced 10 hours or more following gadoxetate administration with minimal risk for the presence of the drug within the milk

There are no data on the excretion of gadoxetate into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering gadoxetate to nursing women.

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