Animal studies have revealed evidence of hepatic, renal, and adrenal lesions at doses 1 to 2 times the maximum recommended human dose. There are no controlled data in human pregnancy.

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.

Use is contraindicated in women who are or may become pregnant.
-Some experts recommend: Use is not recommended.

US FDA pregnancy category: X

Comments:
-Some experts recommend that use is not recommended in women of childbearing potential not using contraception.
-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.
-Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.
-Adequate methods of contraception should be encouraged; hormonal contraceptives are not recommended during treatment.

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.
-Some experts recommend: Use is not recommended.

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

Comment: The effects in the nursing infant are unknown.

See references