Pregnancy: There are limited post-marketing data on the use of domperidone in pregnant women. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown. Therefore, MOTILIUM should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Breast-feeding: The amount of domperidone that could be ingested by an infant through breast milk is low. The maximal relative infant dose (%) is estimated to be about 0.1% of the maternal weight-adjusted dosage. It is not known whether this is harmful to the newborn. Therefore, breast-feeding is not recommended for women who are taking MOTILIUM.