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​​Aripiprazole (Abilify®, Aristada®)​

December 1, 2025

Selected References:

  • Andrade C. 2021. Major congenital malformations associated with exposure to second-generation antipsychotic drugs during pregnancy. J Clin Psychiatry 82:5. 
  • Bellet F, et al. 2015. Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study. Pharmacoepidemiology and Drug Safety 24:368-380. 
  • Bonari L, et al. 2004. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry. 49(11):726-735. 
  • Cuomo A, et al.  2018. Aripiprazole use during pregnancy, peripartum and lactation.  A systematic literature search and review to inform clinical practice.  Journal of Affective Disorders 228;229-237. 
  • Damkier P, Videbech P. 2018. The safety of second-generation antipsychotics during pregnancy: A clinically focused review. CNS Drugs 32(4):351-366. 
  • FDA. 2025. ABILIFY (aripiprazole) Prescribing Information. Available at https://otsuka-us.com/media/static/Abilify-PI.pdf [Accessed 12/2025]. 
  • Fernandez-Abascal B, et al. 2021. Long-acting injectable aripiprazole in pregnant women with schizophrenia: a case-series report. Ther Adv Psychopharmacol. 11: 2045125321991277.  
  • Freeman MP, et al. 2021. Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Arch Womens Ment Health 24, 659–667.  
  • Galbally M, et al. 2018. Aripiprazole and pregnancy: A retrospective, multicenter study. J Affect Disord 238:593-596. 
  • Habermann F, et al. 2013. Atypical antipsychotic drugs and pregnancy outcome: A prospective, cohort study. Journal of Clinical Psychopharmacology 33(4):453-462. 
  • Huybrechts KF, et al. 2016. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 1;73(9):938-46. 
  • Huybrechts KF, et al. 2023. Association of in utero antipsychotic medication exposure with risk of congenital malformations in Nordic countries and the US. JAMA Psychiatry. 1;80(2):156-166. 
  • Lutz UC, et al. 2010. Aripiprazole in pregnancy and lactation: a case report. Journal of Clinical Psychopharmacology 30:205-205. 
  • Mendhekar DN, et al. 2006. Aripiprazole use in pregnant schizoaffective woman. Bipolar Disorder 8:229-300. 
  • Morin C, Chevalier I. 2017. Severe hypernatremic dehydration and lower limb gangrene in an infant exposed to lamotrigine, aripiprazole, and sertraline in breast milk. Breastfeed Med 12:377-80 
  • Nanjundaswamy MH, et al. 2025. Lactation-related side effects of aripiprazole: A study from perinatal psychiatry services in India. J Clin Psychopharmacol. 45(3):258-266. 
  • Naughton S, et al. 2023. Aripiprazole, brexpiprazole, and cariprazine can affect milk supply: Advice to breastfeeding mothers. Australasian Psychiatry. 31(2):201-204. 
  • Nordeng H, et al. 2014. Transfer of aripiprazole to breast milk: a case report. Journal of Clinical Psychopharmacology 34(2):272-75. 
  • Sakai T, et al. 2017. Signal of miscarriage with aripiprazole: A disproportionality analysis of Paulus WE.  2013.  Is the Japanese Adverse Drug Event Report Database. Drug Saf. 40(11):1141-1146 
  • Salvatore, G. 2014. A safety evaluation of aripiprazole for treating schizophrenia during pregnancy and puerperium. Drug Safety Evaluation 13(12):1733-1742. 
  • Schlotterbeck P, et al. 2007. Aripiprazole in human milk. International Journal of Neuropsychopharmacology 10:433. 
  • Straub L, et al. 2022. Association of antipsychotic drug exposure in pregnancy with risk of neurodevelopmental disorders: A national birth cohort study. JAMA Intern Med. 182(5):522–533.  
  • Walker T, et al. 2019. Low dose Abilify (aripiprazole) in combination with Effexor XR (venlafaxine HCl) resulted in cessation of lactation.  Clin Lact 10:56-9. 
  • Wang E, et al. 2025. Comparative safety of antipsychotic medications and mood stabilizers during pregnancy: A systematic review and network meta-analysis of congenital malformations and prenatal outcomes. CNS Drugs. 39(1):1-22. 
  • Watanabe N, et al. 2011. Perinatal use of aripiprazole: a case report. Journal of Clinical Psychopharmacology 31(3):377-9. 
  • Yskes R, et al. 2018. A case of decreased milk production associated with aripiprazole. Prim Care Companion CNS Discord 20(6):18102303. 
  • Zheng L, et al. 2021. Dose adjustment of quetiapine and aripiprazole for pregnant women using physiologically based pharmacokinetic modeling and simulation. Clin Pharmacokinet; May;60 (5):623-635. 

 

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