In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. This sheet talks about whether exposure to docusate sodium may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.

What is docusate sodium?

Docusate sodium is the main ingredient in stool softeners such as Colace® and Surfak® which are used to treat constipation. Constipation decreases the number of bowel movements a person usually has, and can cause gas and bloating. Docusate sodium is commonly found in many drugs and cosmetics. It may also be found in multivitamins and in some prenatal vitamins. In general, docusate sodium is thought to remain in the gut with very little absorbed into the blood stream. If the medication is not in the blood stream, it does not cross the placenta and the fetus/baby would not be exposed.

I just found out I am pregnant. Should I stop taking docusate sodium?

You should always talk with your health care provider before making any changes in your medication. It is important to consider the benefits of treating constipation symptoms during pregnancy. Your health care provider may also want to confirm diagnosis of constipation and see how dietary and other lifestyle therapies may help.

Can use of docusate sodium during pregnancy cause birth defects?

Few studies have been done to look at the possible risks of docusate sodium during pregnancy. However, the available studies show that when used in recommended doses docusate sodium is not expected to increase the chance of birth defects.

What are the dangers of taking too much docusate sodium?

When used in recommended doses, docusate sodium is unlikely to cause problems during pregnancy. However, when more than the recommended amount of this product is used, it can lower the levels of magnesium in a person’s blood. There is one reported case of low magnesium levels in a newborn that was linked to the mother overusing docusate sodium. The baby’s main symptom was jitteriness, which went away by the second day of life. There have been no reported problems linked to the use of recommended levels of docusate sodium in pregnancy.

Can I use docusate sodium while breastfeeding?

While some of the docusate sodium is absorbed by the mother, the amount that passes into milk is likely low. There have been no reports of problems in babies that are breastfeeding while the mother is taking docusate sodium. Be sure to talk to your health care provider about all your choices for breastfeeding.

What if the father of the baby takes docusate sodium?

There are no studies looking at possible problems with conceiving or risks to a pregnancy when the father takes docusate sodium. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures and Pregnancy at http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.

Selected References:

  • Aselton P, et al. 1984. First-trimester drug use and congenital disorders. Obstet Gynecol 65(4):451- 455.
  • Hale, TW. 2012. Medications and Mothers’ Milk. Fifteenth Edition. Amarillo, TX: Hale Publishing L.P.
  • Heinonen OP, et al. 1977. Birth Defects and Drugs in Pregnancy. Littleton, Mass.: John Wright-PSG, pp 385, 442.
  • Jick H, et al. 1981. First-trimester drug use and congenital disorders. JAMA 246(4):343-346.
  • Lameris AL, et al. 1979. Drug induced alterations in Mg2+ homeostasis. Clinical Science 123(1):1.
  • MacKenzie K, et al. 1990. Three-generation reproduction study with dioctyl sodium sulfosuccinate in rats. Fundam Appl Toxicol 15:53-62.
  • Mahadevan U, & Kane S. American Gastroenterological Association Institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul ;131(1):283-311.
  • Schindler AM: Isolated neonatal hypomagnesaemia associated with maternal overuse of stool softener. Lancet 2:822, 1984.
  • Thorpe PG, et al. 2013. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiol Drug Safe 22(9): 1013-1018.