Animal models have revealed evidence of decreased fetal body weight gain, and delayed skeletal ossification; other animal models have revealed evidence of early postnatal pup mortality, with decreased body weight, delayed maturation, and decreased adult fertility in surviving pups at doses reaching maternal toxicity. There are no controlled data in human pregnancy.

Additionally, neonates exposed to vilazodone and other selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Signs and symptoms have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These clinical findings are consistent with either a direct toxic effect of SSRIs and SNRIs or a drug discontinuation syndrome. In some cases, this clinical picture is consistent with serotonin syndrome.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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

US FDA pregnancy category: Not assigned.

Risk summary: There are limited data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, hyperreflexia, jitteriness, tremor, seizures, somnolence, respiratory distress, cyanosis, apnea, hypoglycemia, vomiting, feeding disorder/difficulties, temperature instability irritability, constant crying). The side effects usually arise within 24 hours of delivery and have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.
-Exposed neonates should be monitored for the signs/symptoms of persistent pulmonary hypertension of the newborn (PPHN), serotonin syndrome, and/or withdrawal.

See references

Early pup mortality occurred in animal models exposed to this drug at doses 30 times the maximum recommended human dose during lactation. Surviving pups had decreased body weight and delayed maturation.

This drug should be used only if the potential benefit outweighs the potential risk to the child.

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

Comments: The effects in the nursing infant are unknown.

See references