Urogenital malformations, including absence of a kidney, were found in fetuses in animal studies. Unilateral renal agenesis has been observed in 2 offspring whose mothers received this drug during the first trimester. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can harm a developing fetus.
-Women of childbearing potential should be advised to avoid becoming pregnant.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

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: Data not available


Comments:
-The effects in the nursing infant are unknown.

See references