Three cases of amiloride exposure during pregnancy have been reported. In one, gross fetal malformations were reported following a voluntary abortion in a woman who had received amiloride, captopril and propranolol during her first trimester. Since angiotensin converting enzyme inhibitors are known teratogens, the defects were attributed to captopril.

In two other cases a normal pregnancy and mild intrauterine growth retardation were reported in women treated for Bartter's syndrome and atrial fibrillation, respectively. Both infants were healthy and normal at birth.

Amiloride has been assigned to pregnancy category B by the FDA. Animal studies have revealed no evidence of teratogenicity or impaired fertility, although a decrease in rat pup growth and survival was observed at doses 5 or more times the expected maximum daily dose for humans. There are no controlled data in human pregnancy. Amiloride should only be given during pregnancy when need has been clearly established.

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Animal studies have shown that amiloride is excreted into rat milk in concentrations higher than those found in blood.

There are no data on the excretion of amiloride into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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