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Cariprazine in Human Milk: Cautionary Implications for Use During Lactation
Shreya Balamurali1, Shraddha Trehan, Amy Stark
1School of Medicine, Texas Tech University Health Sciences Center, Amarillo, TX.
Journal of Clinical Psychopharmacology
|May 5, 2026
Summary
Maternal cariprazine (a dopamine D2/D3 partial agonist) use during breastfeeding resulted in detectable levels in breast milk, but infant exposure was generally low. Further research is needed due to reported infant lethargy and metabolite accumulation potential.
Area of Science:
- Pharmacology
- Neonatal Health
- Psychiatry
Background:
- Cariprazine is a dopamine D2/D3 partial agonist used for depression, bipolar disorder (BD), and schizophrenia.
- Women with BD have an increased risk of postpartum mania and psychosis.
- Limited data exist on cariprazine's peripartum safety and infant exposure via breast milk.
Purpose of the Study:
- To assess the risk of infant exposure to maternal cariprazine through breast milk.
- To quantify cariprazine and its metabolites in human milk.
- To evaluate infant safety based on relative infant dose (RID) and reported outcomes.
Main Methods:
- Analyzed breast milk samples from 5 lactating women using cariprazine (1.5-4.5 mg/day).
- Measured cariprazine, desmethylcariprazine (DCAR), and didesmethylcariprazine (DDCAR) using liquid chromatography-tandem mass spectrometry.
- Assessed infant risk via Relative Infant Dose (RID%) and maternal reports of infant outcomes.
Main Results:
- Cariprazine and its metabolites were detected in all milk samples.
- Mean cumulative Relative Infant Dose (RID) was 2.54%, with a maximum of 3.99%.
- Two infants experienced lethargy; one resolved after maternal dose reduction.
Conclusions:
- Estimated infant exposure to cariprazine and metabolites is below safety thresholds.
- Reported infant adverse effects and potential metabolite accumulation warrant further investigation.
- These are the first empirical data on cariprazine during lactation, highlighting the need for more research.
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