Animals studies have revealed evidence of fetotoxicity and embryotoxicity. There are no adequate and well-controlled studies in pregnant women.

To monitor the outcomes of pregnant women exposed to antidepressant, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comment: A pregnancy exposure registry is available.

See references

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as an agent whose effect on the nursing infant is unknown but may be of concern.
-Some experts state that exclusively breastfed infants should be monitored (e.g., drug serum levels).

See references