Animal studies have revealed evidence of embryotoxicity and teratogenicity (e.g., in increased postimplantation loss, abortion, and fetal malformations including absence of kidney or ureter, rudimentary, misshapen, or malpositioned kidney, rib abnormalities, and skeletal variations of accessory skull bones, localized fetal edema, absence of kidney and ureter, abnormalities of the reproductive tract, and developmental variations including misshapen kidney, decreased skeletal ossification and higher mean litter proportions of slightly or moderately malaligned sternebrae at doses approximately equal to the human exposure at the recommended dose. There are no controlled data in human 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 should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug may cause embryofetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage. Oral administration to pregnant animals during the period of organogenesis resulted in malformations, postimplantation loss, and abortion at maternal exposures that were approximately equal to the human exposure at the recommended dose.

Comments:
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 1 month after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 1 week after.
-This drug may impair both male and female fertility.

See references

Use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for at least 1 week after.

See references