No teratogenicity was observed at oral doses up to 1600 mg/kg/day in mice, up to 2000 mg/kg/day in rats and up to 2000 mg/kg/day in cynomolgus monkeys. At an oral dose of 2000 mg/kg/day in rats, maternal toxicity and deaths were seen with increased incidence of early fetal resorption. Spontaneous abortions occurred in cynomolgus monkeys at the maternally toxic oral dose of 2000 mg/kg/day. There are no adequate and well-controlled trials in pregnant women.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

See references

Use should be avoided.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

Following repeated 40 mg twice-a-day dosing in healthy women, average steady-state concentrations in breast milk were 50 ng/mL compared to 255 ng/mL in plasma. Studies in mouse and rats showed a potential for tumorigenicity and enhanced sensitivity of neonatal rats and dogs to the adverse effects of this drug.

See references