Dexlansoprazole

The Basics

What is Dexlansoprazole?

Used to heal and maintain healing of erosive esophagitis and to treat heartburn associated with gastroesophageal reflux disease (GERD).

Brand names for Dexlansoprazole

Dexilant

How Dexlansoprazole is classified

Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors

Dexlansoprazole During Pregnancy

Dexlansoprazole pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dexlansoprazole while pregnant

There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral dexlansoprazole to rabbits during organogenesis at doses up to nine times the maximum recommended human dose (MRHD) (based on body surface area) or with administration of oral lansoprazole to rats and rabbits during organogenesis at doses up to 40 and 16 times the MRHD (based on body surface area), respectively . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data An embryo-fetal development study conducted in rabbits at oral dexlansoprazole doses up to 30 mg/kg/day (approximately nine times the maximum recommended human dexlansoprazole dose [60 mg/day] based on body surface area) during organogenesis showed no effects on fetuses due to dexlansoprazole. In addition, embryo-fetal development studies performed in rats with oral lansoprazole at doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on body surface area) during organogenesis and in rabbits with oral lansoprazole at doses up to 30 mg/kg/day (16 times the recommended human lansoprazole dose based on body surface area) during organogenesis revealed no effects on fetuses due to lansoprazole.

Taking Dexlansoprazole While Breastfeeding

What are recommendations for lactation if you're taking Dexlansoprazole?

Dexlansoprazole is the R -enantiomer of the protein-pump inhibitor, lansoprazole. No information is available on the use of dexlansoprazole or lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount of dexlansoprazole in breastmilk would be harmful.

Maternal / infant drug levels

Dexlansoprazole is the R -enantiomer of the protein-pump inhibitor, lansoprazole. No information is available on the use of dexlansoprazole or lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount of dexlansoprazole in breastmilk would be harmful.

Possible effects of Dexlansoprazole on milk supply

A retrospective claims database study in the United States found that users of proton pump inhibitors had an increased risk of gynecomastia.[1]

One case of elevated serum prolactin and galactorrhea was reported in a 21-year-old man taking lansoprazole (the racemic form). When omeprazole was substituted for lansoprazole, the serum prolactin decreased to the normal range and galactorrhea ceased.[2]

Possible alternatives to Dexlansoprazole

Cimetidine, Famotidine, Nizatidine, Omeprazole, Pantoprazole, Ranitidine, Sucralfate.