Animal tests have reported developmental toxicity (embryolethality, fetal abnormalities, pup mortality, and offspring growth retardation) and dose-related increases in embryonic death, and fetal structural variations (incomplete/irregular ossification of skull bones, sternebrae, and ribs). High doses in animals have been reported to have led to fused sternebrae, increased incidences of embryonic death, and fetal variations (major blood vessel variations, supernumerary ribs, and incomplete skeletal ossification). Offspring of rats whose dams received doses of 10, 60, or 340 mg/kg/day during late gestation and lactation have demonstrated behavioral impairment (tremors), and decreased viability and growth at doses of 60 mg/kg or greater. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Breastfeeding should be avoided for 24 hours after administration of this drug

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

See references