Docusate sodium (Colace®)
SUMMARY: Docusate sodium is considered safe for use in pregnancy when used at the recommended dosage.
Surfactant used as a laxative, stool softener, cerumenolytic. Sodium salt of dioctyl sodium sulfosuccinate (DSS). Molecular weight: 444.56
Metabolism studies indicate that dioctyl sodium sulfosuccinate (DSS) is absorbed from the gastrointestinal tract and
undergoes extensive metabolism. In man the
major route of excretion of DSS metabolites is in the feces [2, 3].
of The Collaborative Perinatal Project found no increase in the incidence of
major malformations among 116 pregnancies
exposed during the first trimester to dioctyl sodium sulfosuccinate
The Boston Collaborative Drug Surveillance Program found no increase in
the incidence of major malformations among 792 pregnancies exposed during the
first trimester to dioctyl sodium sulfosuccinate [5,6]
In addition, Briggs et. al.
reported that data from a surveillance study of Michigan Medicaid recipients did not
support an association between docusate salt and major malformations (cardiovascular defects, oral
clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) in 232 newborns who had been exposed to docusate salt during the first
trimester  .
Schindler reported a case of symptomatic hypomagnesemia in the neonate of woman who had
used docusate sodium chronically throughout her pregnancy .
1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD:
Williams & Wilkins,2002
2. Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974,
3. FAO Nutrition Meetings Report Series, 1974, No. 54.
4. Heinonen OP et al.. Birth Defects and Drugs in Pregnancy. Littleton:Publishing Sciences Group, 1977. p. 442.
5. Jick H, et al . First-trimester drug use and congenital disorders. JAMA. 1981;246:343-6.MEDLINE
6. Aselton P et al. First-trimester drug use and congenital disorders. Obstet Gynecol. 1985;65:451-5.
7. Schindler AM. Isolated neonatal hypomagnesaemia associated with maternal overuse of
stool softener. Lancet. 1984 ;2:822. MEDLINE
Update: 6/26/2007 Mark Curran, M.D. FACOG