Moduretic 5-50 Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: B
Animal studies have revealed decreased pup birth weight and weaning weight at doses that reduced maternal weight gain during and after gestation. Animal studies with amiloride have shown decreased pup growth and survival. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references