Contraindicated

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

Comments: If a pregnancy occurs while taking this drug, the women should be apprised of the potential hazard to the fetus.

Administration of this drug to pregnant women, particularly during the first trimester of pregnancy, causes virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus. It is most likely to occur in the female fetus when the drugs are given in the first trimester. There are no controlled data in human pregnancy.

Oligospermia may occur at high doses.

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Not Recommended

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Due to the potential for serious adverse reactions in breastfed infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references