Animal models have revealed evidence of embryotoxicity and an increased incidence of major anomalies. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: This drug should not be used during the first and third trimesters of pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken this drug during the last trimester of pregnancy.
-A pregnancy exposure registry is available.

See references

The manufacturer makes no recommendation regarding use during lactation.
-Some experts recommend: Use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies other tricyclic antidepressants as drugs whose effects on the nursing infant are unknown but may be of concern.
-Alternative agents (e.g., nortriptyline, paroxetine, sertraline) may be preferred when breastfeeding newborn or preterm infants, or when large doses are necessary.

See references