Summary of Use during Lactation

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.

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]

The Spanish pharmacovigilance system found one case of a 90-year-old man who developed gynecomastia associated with rabeprazole reported during the time period of 1982 to 2006. The reaction occurred after 32 days of therapy and resolved after discontinuation of the drug.[2]

A review article reported that a search of database from the European Pharmacovigilance Centre found 11 cases of gynecomastia, 3 cases of galactorrhea, 2 cases of breast pain and 1 case of breast enlargement associated with rabeprazole. A search of the WHO global pharmacovigilance database found 38 cases of gynecomastia, 29 cases of galactorrhea, 28 cases of breast pain and 5 cases of breast enlargement associated with rabeprazole.[3]

A woman was prescribed metronidazole 400 mg three times a day, and a combination product containing rabeprazole 20 mg and domperidone 30 mg daily for diarrhea and dyspepsia. After 3 days of treatment, she developed bilateral galactorrhea. The combination of rabeprazole and domperidone was thought to be the cause.[4]

A 27-year-old woman with gastroesophageal reflux disease was prescribed rabeprazole 20 mg once daily. After 10 days of treatment, she complained of sudden-onset bilateral galactorrhea. A bilateral breast ultrasound demonstrated dilated retroareolar ducts containing anechoic fluid. Her serum prolactin level was 245 ng/mL (normal range 4.79 to 23.3 ng/mL). Ten days after discontinuing rabeprazole, her serum prolactin had returned to a normal value of 15.0 ng/mL and her symptoms resolved.[5]

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.

Carvajal A, Macias D, Gutierrez A, et al. Gynaecomastia associated with proton pump inhibitors: A case series from the Spanish Pharmacovigilance System. Drug Saf 2007;30:527–31. [PubMed: 17536878]

3.

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]

4.

Patrascu OM, Chopra D, Dwivedi S. Galactorrhoea: Report of two cases. Maedica (Bucur) 2015;10:136–9. [PMC free article: PMC5327809] [PubMed: 28275406]

5.

Sheikh FA, Khakhar Z, Bhogal G, et al. Risk of proton pump inhibitor (PPI)-induced galactorrhea: An uncommon adverse effect of a common drug. Cureus 2025;17:e81050. [PMC free article: PMC12014519] [PubMed: 40271284]

Substance Name

Rabeprazole

CAS Registry Number

117976-89-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Ulcer Agents

Gastrointestinal Agents

Proton Pump Inhibitors