A study in pregnant rats revealed evidence of fetal malformations, fetal growth retardation, and embryo-fetal death at maternal plasma exposures below the human exposure at the clinical dose of 20 mg. 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 has a potential to cause fetal harm when administered to a pregnant woman.

Comments:
-Women of childbearing potential should use effective contraception during treatment and for 1 week after the last dose.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 1 week after the last dose.
-Pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should be apprised of the embryofetal risk associated with this drug.

See references

Breastfeeding is not recommended during use of this drug.

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

Comments:
-No data available on the presence of this drug or its metabolites in human milk or their effects in the nursing infant.
-Owing to its potential to cause severe adverse reactions in breastfed children, this drug is not recommended during breastfeeding and for 1 week after the last dose.

See references