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Paliperidone Pregnancy and Breastfeeding Warnings

Paliperidone is also known as: Invega, Invega Hafyera, Invega Sustenna, Invega Trinza

Medically reviewed by Last updated on Feb 5, 2020.

Paliperidone Pregnancy Warnings

Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester. Cases have varied widely in severity from self-limited cases to reports of neonates who have required intensive support and prolonged hospitalization. One case of agenesis of the corpus callosum has been received in an infant exposed to risperidone in utero, although the relationship to this drug is unknown. Animal studies have revealed an increase in stillbirths and an increase in pup deaths in the first 4 days of life. Hyperprolactinemia caused by this drug may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis. 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:

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

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

-A pregnancy exposure registry is available.
-Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

See references

Paliperidone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

-Due to lack of published data and the potential for serious adverse reactions in nursing infants, other agents may be preferred, especially while nursing a newborn or preterm infant.
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern if exposure is prolonged.

Paliperidone is 9-hydroxyrisperidone, the active metabolite of risperidone. Following risperidone administration, 9-hydroxyrisperidone has been measured in milk and plasma. Calculations using an average milk-to-plasma ratio of 0.3 (determined from 3 reports of risperidone use during breastfeeding) suggests an exclusively breastfed infant may expect to receive about 1% of the maternal weight-adjusted dose of paliperidone. Since paliperidone is only available as a sustained-release product, timing of nursing with respect to drug levels will not be helpful. Paliperidone has been detected at very low levels in plasma up to 18 months after a single-dose of the 3-month extended-release product. The clinical significance of that on the breastfed infant is not known.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Invega Trinza (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.
  4. "Product Information. Invega (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.
  5. "Product Information. Invega Sustenna (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Invega Sustenna (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  6. "Product Information. Invega Trinza (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.
  7. "Product Information. Invega (paliperidone)." Janssen Pharmaceuticals, Titusville, NJ.

Further information

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