GERD Home > Aciphex Sprinkle and Pregnancy

Is it safe for women to take Aciphex Sprinkle (rabeprazole sprinkle) during pregnancy? Although the drug has not been adequately studied in pregnant women, animal studies have shown that it is probably safe for use during pregnancy. However, animals do not always respond to medications in the same way that humans do, so talk to your healthcare provider about any risks that may apply to you.

Can Pregnant Women Take Aciphex Sprinkle?

Aciphex® Sprinkle™ (rabeprazole sprinkle) is a prescription proton pump inhibitor (PPI). It is approved to treat gastroesophageal reflux disease (GERD) in children. Based on the results of animal studies, this medication is probably safe for use in pregnancy. However, the full risks are unknown at this time.

What Is Pregnancy Category B?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Aciphex Sprinkle is classified as a pregnancy Category B medication.
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.
Aciphex Sprinkle has not been adequately studied in pregnant women. However, in animal studies, the drug did not appear to cause birth defects or other problems when given to pregnant rats and rabbits. It did reduce weight gain in newborn rats and rabbits when given in very high doses to the mothers in late pregnancy and during breastfeeding.
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
While Aciphex Sprinkle is approved for the treatment of GERD in children ages 1 to 11 years old, a healthcare provider may prescribe it off-label for an adult. Therefore, information about Aciphex Sprinkle and pregnancy may be relevant to some individuals.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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