Studies in animals have shown reproductive toxicity, including teratogenesis and fetotoxicity at doses less than the recommended human maintenance dose. Observed teratogenic findings were cleft palate, kyphosis, heart ventricular septal defects, microcephaly, and exencephaly. There are no adequate and well controlled studies 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 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.

UK: Use should be avoided during the first trimesters of pregnancy; use is not recommended unless clearly needed.
AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

Comments: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risks.

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

See references

This drug reduced the survival of the offspring of adult rats dosed orally with 375 mg/kg/day (1.5 times the maximum recommended human dose based on body surface area).

UK: Use is contraindicated.
US: Use is not recommended.

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

See references