Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category:
-Microsize formulation: X
-Ultramicrosize formulation: Not formally assigned to a pregnancy category.

Comments:
-Effective contraception (at least 2 reliable forms) is required during therapy and for 1 month after the last dose; local protocol should be consulted regarding contraception timing.
-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.
-Male patients should not father children for at least 6 months after the last dose; use of effective contraception (i.e., barrier contraception) is recommended.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy; however, there are reports of congenital anomalies, including 2 cases of conjoined twins in women taking this drug during the first trimester of pregnancy, as well as increased risk of spontaneous abortion.

This drug may cause fetal harm when used during pregnancy; it is contraindicated in women who are or may become pregnant during therapy or those intending to become pregnant within 1 month after stopping therapy. Women using estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while taking this drug; an alternate or second method of contraception may be indicated during coadministration.

Chromosomal aberrations in animal spermatocytes have been observed with this drug. Male patients should wait at least 6 months after stopping this drug before fathering a child.

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

Safety has not been established; according to some experts, use should be avoided.
-According to some authorities: Use is contraindicated.
-According to some authorities: 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:
-No data available on the use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.

See references