Animal studies in rats and rabbits have revealed evidence of developmental toxicity (e.g., decreased fetal weight, increased incidence of minor vertebral alterations, delayed ossification) at exposure levels 6 to 12 times greater than the clinical maximum recommended daily dose of 80 mg. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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: B1
US FDA pregnancy category: C

See references

Use with caution

Excreted into human milk: Yes

Comment: Infant exposure can be minimized by avoiding breastfeeding for 24 hours after treatment.

Following a single 80 mg dose, mean excretion in breast milk over 24 hours (n=8) was approximately 0.02% of administered dose. The concentration of the active metabolite was not measured (its serotonin agonist activity is 10% of parent drug). For infants older than 2 months, adverse effects are not expected.

See references