Is Pantoprazole safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Pantoprazole. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Maternal pantoprazole doses of 40 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects 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.[3]
A review article reported that a search of database from the European Pharmacovigilance Centre found 48 cases of gynecomastia, 3 cases of galactorrhea, 14 cases of breast pain and 4 cases of breast enlargement associated with pantoprazole. A search of the WHO global pharmacovigilance database found 97 cases of gynecomastia, 13 cases of galactorrhea, 35 cases of breast pain and 16 cases of breast enlargement associated with pantoprazole.[4]
Levels in milk
Maternal Levels. A mother who was 10 months postpartum and partially nursing her infant was given a single 40 mg dose of oral pantoprazole. Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of 36 mcg/L and 24 mcg/L, respectively, at those times. It was not detectable (<10 mcg/L) in milk at 6, 8 and 24 hours after the dose. The authors estimated that a fully breastfed infant would receive 0.14% of the maternal weight-adjusted dosage.[1]
Sixteen lactating, but not breastfeeding, women were given oral pantoprazole 40 mg daily for one week. Breastmilk samples were obtained at baseline and 1.5, 3, 4.5, and 6 h following the dose on days 1 and 7. Of 149 breastmilk samples, only 26 had detectable (>0.03 mg/L) pantoprazole concentrations. Peak milk concentrations typically occurred at 3 hours after the dose on day 7. Using the average peak milk concentration, the estimated worst-case infant daily dosage via milk was approximately 0.011 mg/kg. This represents a conservative estimate, as peak milk concentrations are not sustained over the full 24-hour dosing interval.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Pantoprazole in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Pantoprazole” (LM409). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.