Animal studies of administration of a human dose on 4 occasions (twice prior to mating, once during gestation, once during lactation) showed no fetal malformations or variations and no adverse effect on pup weight. 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.

The manufacturer makes no recommendation regarding use during pregnancy.
According to some authorities, this drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Available data on use of this drug in pregnant women are insufficient to inform a drug related risk.

Comments:
-There is insufficient data on use in pregnancy to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal studies of administration of human doses did not reveal evidence of fetal harm.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references