Animal reproductive studies have shown evidence that this drug and its cis-isomer was embryocidal and fetocidal at drug exposures approximately 15-times the MRHD (on an AUC basis with a maternal oral dose of 25 mg/kg/day). It is not known whether this drug can cause a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes in humans. There is insufficient data available to determine whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

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 animal studies and its mechanism of action, this drug can cause fetal harm.

Comment: The formulation of this drug contains alcohol and its use during pregnancy may be associated with fetal harm including central nervous system abnormalities, behavioral disorders and impaired intellectual development.

See references

Use is not recommended.

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

Comments:
-No data are available regarding the presence of this drug in human milk, the effects on the breast-fed infant, or the effects on milk production.
-Nursing women should be advised not to breastfeed during therapy and for at least 7 days after the last dose.

See references