Animal reproduction studies have not been conducted. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to this drug. This drug should not be used in early pregnancy unless in the judgment of the physician the potential benefits outweigh the potential harm. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed

US FDA pregnancy category: C

Comments: There have been reports of fetal and congenital abnormalities following in utero exposure.

See references

Benefit should outweigh risk

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

Comments: This drug and/or its metabolites are excreted in the milk of dogs; there is not information on its excretion in human milk.

See references