Carafate (Sucralfate) and Breastfeeding
Carafate (sucralfate) is safe to use during breastfeeding, as it has minimal systemic absorption and is unlikely to be excreted into breast milk in clinically significant amounts.
Primary Evidence from FDA Labeling
The FDA label for sucralfate states that "it is not known whether this drug is excreted in human milk" and recommends that "caution should be exercised when sucralfate is administered to a nursing woman" 1. However, this conservative language reflects the lack of formal studies rather than evidence of harm.
Clinical Rationale for Safety
The pharmacologic properties of sucralfate make it one of the safest gastrointestinal medications during breastfeeding:
Sucralfate acts locally in the gastrointestinal tract with minimal systemic absorption, meaning very little drug enters the maternal bloodstream to potentially transfer into breast milk 2
For reflux disease during lactation, sucralfate is specifically preferred because it has minimal systemic absorption compared to other agents 2
Drugs with poor systemic absorption are considered first-line therapy for gastrointestinal conditions in breastfeeding mothers, as they pose negligible risk to the infant 3
Practical Considerations
The dose of most drugs transferred into milk is small and does not lead to clinically significant effects on the infant 4
Medications that are not absorbed systemically should be considered first-line therapy for gastrointestinal conditions during breastfeeding 3
You can continue breastfeeding without interruption while taking sucralfate 2
Common Pitfalls to Avoid
Do not confuse the FDA's cautionary language with actual evidence of harm—the statement reflects lack of formal lactation studies, not documented toxicity 1
Do not unnecessarily discontinue breastfeeding, as the substantial benefits of breastfeeding for both infant and maternal health outweigh theoretical minimal drug exposure 5
Be aware that most commonly used drugs are relatively safe for breastfed babies, with the dose received via milk being generally small and much less than known safe doses given directly to infants 6