Animal studies have revealed evidence of teratogenicity, embryotoxicity, placental transfer, and reproductive toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

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.

Use is contraindicated.

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

Comments:
-A negative pregnancy test must be obtained prior to initiation, monthly during treatment, and for 1 month after discontinuation.
-Adequate methods of contraception must be used during treatment and for 1 month after discontinuing treatment.
-Patients may choose one highly effective form of contraception (e.g., intrauterine device, contraceptive implants, tubal sterilization) or a combination of methods (e.g., hormone method with barrier method or 2 barrier methods); if a partner's vasectomy is the chosen method, a hormone or barrier method must also be used concurrently.
-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

Use is nor recommended. According to some authorities, use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Hypotension may occur in breasted infants.

See references