Risperidone Pregnancy and Breastfeeding Warnings

Brand names: Perseris, Risperdal, Risperdal Consta, Risperdal M-Tab, Risvan, Rykindo, Uzedy

Medically reviewed by Drugs.com. Last updated on Jun 18, 2025.

Risperidone Pregnancy Warnings

Safety has not been established during pregnancy.

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

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

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder) following delivery.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

Animal studies have reported maternal and fetal harm. Administration during organogenesis has produced cleft palates in offspring as well as maternal toxicity (decreased body weight, weight gain and food intake). Additionally, there were reports of impaired learning due to neuronal cell death, delayed postnatal development and growth, increased offspring mortality, stillbirth, decreased birth weight, post-implantation loss, increased malformations (external, visceral, and skeletal), and impaired maternal behavior in that offspring body weight gain and survival were reduced. 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 by visiting https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

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.

See references

Risperidone 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

Comments:
-Due to lack of published data and the potential for serious adverse reaction in nursing infants, other agents may be preferred, especially while nursing a newborn or preterm infant.
-Women should not breastfeed for at least 12 weeks after receiving a long-acting injection of the drug.
-Other antipsychotics are considered agents for which the effect on nursing infants is unknown but may be of concern, especially when given for long periods by the American Academy of Pediatrics.

An exclusively breastfed infant may expect to receive 4.3% of the maternal weight-adjusted drug dosage. This calculation is based on a study in 1 mother receiving risperidone 6 mg daily and having her milk and serum levels of risperidone and its active metabolite (9-hydroxyrisperidone) measured over 24 hours.

See references

Further information

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

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