Summary of Use during Lactation

Dexlansoprazole is the R-enantiomer of the proton-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.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

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

A review article reported that a search of database from the European Pharmacovigilance Centre found 1 case of gynecomastia, no cases of galactorrhea, 1 cases of breast pain and 1 case of breast enlargement associated with dexlansoprazole. A search of the WHO global pharmacovigilance database found 2 cases of gynecomastia, no cases of galactorrhea, 4 cases of breast pain and 1 case of breast enlargement associated with dexlansoprazole.[2]

Alternate Drugs to Consider

Antacids, Cimetidine, Famotidine, Omeprazole, Pantoprazole, Sucralfate

References

1.

He B, Carleton B, Etminan M. Risk of gynecomastia with users of proton pump inhibitors. Pharmacotherapy. 2019;39:614–8. [PubMed: 30865318]

2.

Ashfaq M, Haroon MZ, Alkahraman YM. Proton pump inhibitors therapy and risk of hyperprolactinemia with associated sexual disorders. Endocr Regul. 2022;56:134–47. [PubMed: 35489049]

Substance Name

Dexlansoprazole

CAS Registry Number

138530-94-6

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Ulcer Agents

Gastrointestinal Agents

Proton Pump Inhibitors