Is Colace safe during pregnancy

Colace (generic name docusate or docusate sodium) is a stool softener usually considered safe for managing constipation in pregnancy [1, 2], as its active ingredients are minimally absorbed in the mother’s bloodstream, thus posing no serious threats to the developing baby [3].

Colace (docusate sodium) FDA Pregnancy Category

It has not been formally evaluated and classified by the FDA. So, it should only be taken in pregnancy when clearly needed and when the potential benefits outweigh any possible risks for complications [4].

How much Colace can you take while pregnant

The duration and dosage depends on the purpose of use, any chronic or underlying complications as well as the stage of pregnancy you are in. However in most cases, it is only recommended for a short term use, when prescribed by your gynecologist [4, 5].

Are there any risks of taking Colace during pregnancy

The Collaborative Perinatal Project studied 30 women who used docusate (Colace) in the first trimester and 116 women who used it anytime during their pregnancy. The results reported birth defects in 3 babies [4].

A Michigan Medicaid study reviewed 229,101 deliveries between 1985 and 1992, where 232 women were exposed to docusate in their first trimester and 3003 were exposed anytime in their pregnancy. In the first trimester exposure group, 9 malformations were reported, including a case of cardiovascular defect and polydactyly each.

Another reviewed data with 6589 first trimester exposures between 1980 and 1983 showed no association between docusate usage and any congenital anomalies [4].

In one case, symptomatic hypomagnesemia was reported in the baby within one day after birth where the mother had taken a 100mg dosage of docusate sodium daily throughout her pregnancy [6].

Colace while breastfeeding

Not much data is available regarding the excretion of Colace into breast milk [7] and its possible effects on a nursing baby. So, it is always recommended to talk to your doctor before considering using it. However, it is commonly considered safe for short term use [8].

One study, done with 35 nursing mothers receiving a docusate-dihydroxyanthraquinone combination, reported diarrhea in 1 breastfeeding infant [9].


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