The Basics

What is Docusate?

A stool softener that makes bowel movements softer and easier to pass.

Brand names for Docusate

Tolinase, Colace

How Docusate is classified

Gastrointestinal Agents, Laxatives, Surface-Active Agents


Docusate During Pregnancy

Docusate pregnancy category

Category C
Note that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Docusate while pregnant

Taking Docusate sodium while pregnant is generally safe. TOLINASE (tolazamide) , administered to pregnant rats at ten times the human dose, decreased litter size but did not produce terato-genic effects in the offspring. In rats treated at a daily dose of 14 mg/kg no reproductive aberrations or drug related fetal anomalies were noted. At an elevated dose of 100 mg/kg per day there was a reduction in the number of pups born and an increased perinatal mortality. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, TOLINASE (tolazamide) is not recommended for the treatment of the pregnant diabetic patient. Serious consideration should also be given to the possible hazards of the use of TOLINASE (tolazamide) in women of child bearing age and in those who might become pregnant while using the drug. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.


Taking Docusate While Breastfeeding

What are recommendations for lactation if you're taking Docusate?

Docusate is minimally absorbed from the gastrointestinal tract and therefore the drug is unlikely to be found in the maternal serum or breastmilk. Laxatives that are completely unabsorbed may be preferred.[2]

Maternal / infant drug levels

Docusate is minimally absorbed from the gastrointestinal tract and therefore the drug is unlikely to be found in the maternal serum or breastmilk. Laxatives that are completely unabsorbed may be preferred.[2]

Possible effects of Docusate on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Docusate

Bisacodyl, Magnesium Hydroxide, Psyllium, Senna.


List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/

1. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210:259-63. PMID: 4570522
2. Lewis JH, Weingold AB and the Committee of FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80:912-23. PMID: 2864852


Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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