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Sucralfate and Pregnancy
When large doses of sucralfate (Carafate) were given to pregnant animals, the medication did not appear to cause harm to the fetus. The FDA considers this drug a pregnancy Category B medication, so it is probably safe for use during pregnancy. However, sucralfate should only be prescribed when the benefits outweigh the risks.
Sucralfate (Carafate®) is a prescription medication approved to treat ulcers (although it is sometimes used "off-label" for other reasons). This medication is probably safe for use during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans (but have caused problems in laboratory animals) are also given a Category B rating.
In studies where high doses of sucralfate were given to pregnant animals, no harm to the fetus was seen. This makes sense, as very little (if any) of the medication is absorbed from the digestive tract to the rest of the body.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using sucralfate before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD