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Brexpiprazole Pregnancy and Breastfeeding Warnings

Brexpiprazole is also known as: Rexulti

Medically reviewed by Last updated on May 9, 2018.

Brexpiprazole Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Risk Summary: There are no adequate and well-controlled study 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.

Animal studies have revealed no evidence of teratogenicity, however, pregnant rats receiving 73 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation had an increased number of perinatal pup deaths. Impaired nursing by dams, low birth weight, and decreased body weight gain in pups were observed at 73 times MRHD, but not at 24 times the MRHD. There are no controlled data in human pregnancy.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; in some cases symptoms have been self-limited and in other cases neonates have required intensive care unit support and prolonged hospitalization.

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.

See references

Brexpiprazole Breastfeeding Warnings

Lactation studies have not been conducted to assess the effects of this drug on the breastfed infant or the effects on milk production.

Animal models developed milk levels of approximately 1- to 2-fold times maternal blood levels.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: Benefit should outweigh risk.

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

-The effects in the nursing infant are unknown.
-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.

See references

References for pregnancy information

  1. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

Further information

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