Although studies in animals, with the dosage of 160 mg/kg/day and general clinical use of domperidone in human have not demonstrated teratogenic effects, Dompel should be used in pregnant women and suspected pregnant women only if the potential benefit justifies the potential risk.
It is reported that domperidone is secreted in milk mainly as metabolites in animal studies (rat): Following oral and IV administration of 2.5-mg/kg dose, maximum concentrations in the breast milk were 40 mcg/mL and 800 mcg/mL, respectively. A small proportion of Dompel can be excreted in human milk, but harm to neonates has not been reported. Therefore, Dompel should be used in nursing mothers only if the potential benefit justifies the potential risk.