Sincalide has been assigned to pregnancy category B by the FDA. Reproduction studies in rats in which sincalide was administered subcutaneously at doses up to 12.5 times the maximum recommended human dose revealed no evidence of harm to the fetus due to sincalide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sincalide should not be administered to pregnant women near term because of its effect on smooth muscle; the possibility of inducing premature labor exists.

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There are no data on the excretion of sincalide into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, the manufacturer recommends caution when administering sincalide to a nursing woman.

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