Docusate has not been formally assigned to a pregnancy category by the FDA. Docusate has been assigned to Risk Factor C by Briggs et al. No congenital defects have been associated with docusate use during pregnancy. Docusate should only be used during pregnancy if there are no other alternatives and the benefit outweighs the risk.

During the Collaborative Perinatal Project, 30 exposures to docusate during the first trimester, and 116 exposures to docusate anytime during pregnancy were recorded. Malformations were reported in 3 children (2.23 expected).

In a review of 229,101 deliveries to Michigan Medicaid patients during 1985 to 1992, 232 first-trimester exposures to docusate were recorded and 3003 exposures anytime during pregnancy. A total of 9 birth defects were reported with first trimester exposure (9 expected) and included 1 cardiovascular defect and 1 case of polydactyly. Review of 6589 first trimester exposures in a previous review of data from 1980 to 1983 also revealed no association between docusate and congenital abnormalities. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

A published report of 35 women exposed to docusate and dihydroxyanthraquinone also revealed no association between docusate and adverse fetal outcome.

Hypomagnesemia was discovered within 22 hours of birth in one neonate whose mother had used docusate, 100 mg per day or more, chronically throughout pregnancy. The mother also exhibited hypomagnesemia until docusate use was discontinued.

See references

There are no data on the excretion of docusate into human milk. In one study of 35 women receiving a combination of docusate and dihydroxyanthraquinone, diarrhea was reported in one nursing infant.

See references