Can I take rabeprazole while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. No evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times the human area under the plasma concentration-time curve (AUC) at the recommended dose for GERD, in rats and rabbits, respectively [see Data] . Changes in bone morphology were observed in offspring of rats treated with oral doses of a different PPI through most of pregnancy and lactation. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [ see Data] .

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Rabeprazole sodium (oral), Torrent Pharmaceuticals Limited. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Because no information is available on the use of rabeprazole during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Rabeprazole” (LM410), quoted verbatim. Everything LactMed reports about Rabeprazole while breastfeeding.

8.2 Lactation Risk Summary Lactation studies have not been conducted to assess the presence of rabeprazole in human milk, the effects of rabeprazole on the breastfed infant, or the effects of rabeprazole on milk production. Rabeprazole is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for rabeprazole sodium delayed-release tablets and any potential adverse effects on the breastfed infant from rabeprazole sodium delayed-release tablets or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: Rabeprazole sodium (oral), Torrent Pharmaceuticals Limited. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.