Animal studies showed decreased offspring viability and renal anomalies in male offspring at exposures about equal to or less than the recommended human exposure. No fetal effects were noted in a different animal model at doses equivalent to the human dose. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

See references

This drug was rapidly and extensively secreted into maternal milk in animal studies, at higher concentrations than in maternal plasma.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No data are available on the presence of this drug or its metabolites in human milk, effects on the breastfed infant, or effects on milk production.

See references