Adequate animal studies have not been performed. There are no controlled data in human pregnancy. The molecular weight is low enough that fetal exposure should be expected.

The Collaborative Perinatal Project monitored 21 mother-child pairs exposed to monoamine oxidase inhibitors during the first trimester of pregnancy; one of which was exposed to this drug. An increased risk of malformation was observed; however, details were not given.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

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 should be avoided, especially during the first and last trimesters of pregnancy; this drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: C

Comments:
-The effect of this drug on neonatal fine brain structure development is unknown.
-A pregnancy exposure registry is available.

See references

This drug should be used only if clearly needed.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Because of its low molecular weight, excretion into breast milk is expected.

See references