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Iloperidone Pregnancy and Breastfeeding Warnings

Brand names: Fanapt

Medically reviewed by Last updated on Jan 26, 2023.

Iloperidone Pregnancy Warnings

In animal studies, developmental toxicity was observed, but teratogenicity was not demonstrated. Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester. As with other drugs that antagonize dopamine D2 receptors, iloperidone elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadalsteroidogenesis in both female and male patients. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information:

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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

-Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery.
-A pregnancy exposure registry is available.

See references

Iloperidone Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

-The American Academy of Pediatrics considers other atypical antipsychotics drugs for which the effect on nursing infants is unknown but may be of concern.

Animal data have shown that this drug was excreted in milk during lactation.

See references

References for pregnancy information

  1. Product Information. Fanapt (iloperidone). Vanda Pharmaceuticals Inc. 2009.

References for breastfeeding information

  1. Product Information. Fanapt (iloperidone). Vanda Pharmaceuticals Inc. 2009.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  3. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.