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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Aripiprazole

Last Revision: July 20, 2019.

Estimated reading time: 7 minutes

CASRN: 129722-12-9

Chemical structure

Drug Levels and Effects

Summary of Use during Lactation

Limited information indicates that maternal doses of aripiprazole up to 15 mg daily produce low levels in milk, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.[1] Aripiprazole can lower serum prolactin in a dose-related manner. Cases of lactation cessation have occurred, but cases of gynecomastia and galactorrhea have also been reported.

Drug Levels

Maternal Levels. A women who was 6 months postpartum was taking aripiprazole 15 mg by mouth daily. Milk levels after 11 and 12 days of therapy (times not stated) at that dose were 13 and 14 mcg/L.[2]

A woman took aripiprazole 15 mg daily by mouth during pregnancy and postpartum. At 3 days postpartum, aripiprazole was not detectable in colostrum because of an unknown substance that interfered with the assay. On day 27 postpartum, 3 additional milk samples were collected at 30 minutes before the dose (24 hours after the last dose), and 4 and 10 hours after the dose. The drug and its metabolite were undetectable (<10 mcg/L) in all samples. The authors estimated that a fully breastfed infant would receive less than 0.7% of the maternal weight-adjusted dosage.[3]

A woman was taking aripiprazole 18 mg daily. On day 6 postpartum, a breastmilk sample (time not reported) contained a concentration of aripiprazole of 38.7 mcg/L.[4]

A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. Mid-nursing milk samples were obtained at 8 and 10 weeks postpartum over a 24-hour period after the dose. Aripiprazole and dehydroaripiprazole were measured in the milk. On the first sampling day, mean milk concentrations were 52.6 mcg/L of aripiprazole and 8.8 mcg/L for the metabolite. On the second day, mean milk concentrations were 53.6 and 6.3 mcg/L, respectively. The authors calculated that a 5 kg infant would receive a daily dose of 47 mcg daily and the weight-adjusted dosage would be 8.3% of the maternal dosage.[5]

Infant Levels. A woman was taking aripiprazole 18 mg daily during pregnancy and postpartum. On day 6 her breastfed infant had a serum concentration of 7.6 mcg/L, although some portion of the concentration could have been residual from transplacental transmission because of the drug's on half-life.[4]

Effects in Breastfed Infants

A woman took aripiprazole 15 mg daily by mouth during pregnancy and postpartum. She breastfed her infant (amount not stated) and at 3 months of age, the infant was growing normally.[3]

A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. She exclusively breastfed her infant for 6 weeks, then was partially breastfed. At 4 months of age the infant was still breastfeeding and had normal psychomotor and behavioral development and had reached the expected milestones for her age.[5]

A 12-day-old exclusively breastfed male infant presented with severe weight loss and hypernatremic dehydration because of inadequate milk intake and a 30% weight loss since birth. The infant's mother was being treated for bipolar disorder with lamotrigine 250 mg orally once daily, aripiprazole 15 mg orally once daily, and sertraline 100 mg orally once daily. She was also taking levothyroxine 50 mcg once daily, a prenatal multivitamin, and folic acid. On initial evaluation in the emergency department, he was pale, with marbled skin, dry mucous membranes, decreased skin turgor, and bluish feet with prolonged capillary refill. The right foot eventually became darker with blackened toes and he developed gangrene of the right lower limb, which did not respond to medical therapy and required amputation of all five toes and surgical debridement of the metatarsals. Necrosis was attributed to arterial microthrombi caused by disseminated intravascular coagulation after severe dehydration. The authors considered the mother's medications as a possible cause of the dehydration and related problems.[6]

Effects on Lactation and Breastmilk

Unlike the phenothiazines, aripiprazole has a minimal effect on serum prolactin levels and it has been used to reverse hyperprolactinemia in nonlactating patients taking other antipsychotics.[7][8][9][10][11][12][13][14][15][16] Case reports of both decreased lactation in nursing mothers and cases of hyperprolactinemia and galactorrhea in patients taking aripiprazole have been reported.[17][18][19][20][21][22][23] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

One woman began taking aripiprazole 10 mg daily at week 20 of pregnancy. She underwent a cesarean section delivery at term, but was unable to establish lactation. The authors suggested that more data are needed to determine if aripiprazole adversely affects lactation.[24]

A woman took aripiprazole 10 mg daily by mouth beginning in week 9 of pregnancy and continuing postpartum. She exclusively breastfed her infant for 6 weeks, but then began supplementation because of insufficient milk production. Her serum prolactin was 35 to 40 mcg/L, which is lower than expected for a nursing mother. The authors speculated that the aripiprazole might have been the cause of her low serum prolactin and diminished her milk supply.[5]

A woman with bipolar disorder was taking lithium during pregnancy and postpartum. At 10 days postpartum, her infant's serum lithium level was 0.26 mmol/L, so lithium was discontinued. Quetiapine was begun, but discontinued because of maternal sedation. Aripiprazole 2.5 mg daily was begun and within 24 hours, the mother noted a marked decrease in milk supply. After 2 weeks of working with a lactation consultant, she continued to have lactation difficulties and she switched back to lithium. Within 48 hours, her milk supply improved markedly.[25]

A retrospective study of outpatients receiving an average aripiprazole dose of 17.3 mg daily (n = 20) or another antipsychotic (n = 141) found that those receiving such high-dose aripiprazole had an 81% chance of having hypoprolactinemia. Patients not treated with aripiprazole had only a 2.9% chance of having hypoprolactinemia.[26]

The breastfeeding mother of a 5-week-old infant was diagnosed with bipolar disorder, panic attacks and anxiety disorder. She was started on hydroxyzine 50 mg at an unspecified interval and took it for 3 to 5 days with no effect on milk production. She was then started on aripiprazole 5 mg at an unspecified interval. After 5 days, she reported a decrease in milk production that required supplementation with formula. Nine days after stopping both drugs, her milk supply returned to normal. The decreased milk supply was possibly caused by the medications, with aripiprazole most likely.[22]

A woman with chronic depression was treated throughout pregnancy with extended-release venlafaxine 225 mg daily. She gave birth by cesarean section at 36.5 weeks and began to breastfeed her infant. The infant was not nursing adequately, but the mother pumped milk after each feeding and used it to supplement the infant. It was estimated that she was producing at least 900 mL of milk daily. By 8 days postpartum, she began to experience depression and aripiprazole 2 mg daily, which she had taken before pregnancy, was added to her regimen. After 3 days of combined therapy, she noticed a decrease in milk supply, and withing 21 days, lactation had ceased completely. Either aripiprazole or the combination with venlafaxine possibly caused a decrease in milk supply.[23]

A woman with major depressive disorder received duloxetine 40 mg twice daily. After 2 weeks, she developed menstrual irregularities and a milky discharge from her breasts. Her serum prolactin was elevated at 205 mcg/L. The duloxetine dosage was decreased to 60 mg once daily and aripiprazole was begun at 2.5 mg daily and then increased to 5 mg daily. Within 2 weeks, galactorrhea had stopped and the serum prolactin had decreased to 118 mcg/L. Six weeks later, serum prolactin was 39 mcg/L. The combination was continued for another 39 weeks with no return of galactorrhea.[27]

Alternate Drugs to Consider

Haloperidol, Olanzapine, Quetiapine, Risperidone

References

1.
Uguz F. Second-generation antipsychotics during the lactation period: A comparative systematic review on infant safety. J Clin Psychopharmacol. 2016;36:244-52. [PubMed: 27028982]
2.
Schlotterbeck P, Leube D, Kircher T, Hiemke C, Grunder G. Aripiprazole in human milk. Int J Neuropsychopharmacol. 2007;10:433. [PubMed: 17291382]
3.
Lutz UC, Hiemke C, Wiatr G et al. Aripiprazole in pregnancy and lactation a case report. J Clin Psychopharmacol. 2010;30:204-5. Letter. [PubMed: 20520299]
4.
Watanabe N, Kasahara M, Sugibayashi R et al. Perinatal use of aripiprazole: a case report. J Clin Psychopharmacol. 2011;31:377-9. [PubMed: 21532364]
5.
Nordeng H, Gjerdalen G, Brede WR et al. Transfer of aripiprazole to breast milk: A case report. J Clin Psychopharmacol. 2014;34:272-5. [PubMed: 24525642]
6.
Morin C, Chevalier I. Severe hypernatremic dehydration and lower limb gangrene in an infant exposed to lamotrigine, aripiprazole, and sertraline in breast milk. Breastfeed Med. 2017;12:377-80. [PubMed: 28481632]
7.
Goodnick PJ, Rodriguez L, Santana O. Antipsychotics: impact on prolactin levels. Expert Opin Pharmacother. 2002;3:1381-91. [PubMed: 12387684]
8.
Kane JM, Carson WH, Saha AR et al. Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2002;63:763-71. [PubMed: 12363115]
9.
Byerly MJ, Marcus RN, Tran QV et al. Effects of aripiprazole on prolactin levels in subjects with schizophrenia during cross-titration with risperidone or olanzapine: analysis of a randomized, open-label study. Schizophr Res. 2009;107:218-22. [PubMed: 19038534]
10.
Boggs AA, Bihday C, Boggs DL. Aripiprazole's effects on risperidone consta induced hyperprolactinemia: A case report. J Pharm Pract. 2012;25:298. Abstract. DOI: 10.1177/0897190012441353. [CrossRef]
11.
Lorenz RA, Weinstein B. Resolution of haloperidol-induced hyperprolactinemia with aripiprazole. J Clin Psychopharmacol. 2007;27:524-5. [PubMed: 17873694]
12.
Rocha FL, Hara C, Ramos MG. Using aripiprazole to attenuate paliperidone-induced hyperprolactinemia. Prog Neuropsychopharmacol Biol Psychiatry. 2010;34:1153-4. [PubMed: 20547197]
13.
van Kooten M, Arends J, Cohen D. Preliminary report: a naturalistic study of the effect of aripiprazole addition on risperidone-related hyperprolactinemia in patients treated with risperidone long-acting injection. J Clin Psychopharmacol. 2011;31:126-8. [PubMed: 21192158]
14.
Wahl R, Ostroff R. Reversal of symptomatic hyperprolactinemia by aripiprazole. Am J Psychiatry. 2005;162:1542-3. [PubMed: 16055781]
15.
Wolf J, Fiedler U. Hyperprolactinemia and amenorrhea associated with olanzapine normalized after addition of aripiprazole. J Clin Pharm Ther. 2007;32:197-8. [PubMed: 17381670]
16.
Kelly DL, Powell MM, Wehring HJ et al. Adjunct aripiprazole reduces prolactin and prolactin-related adverse effects in premenopausal women with psychosis: Results from the DAAMSEL clinical trial. J Clin Psychopharmacol. 2018;38:317-26. [PMC free article: PMC6103648] [PubMed: 29912799]
17.
Mendhekar DN, Andrade C. Galactorrhea with aripiprazole. Can J Psychiatry. 2005;50:243. Letter. [PubMed: 15898468]
18.
Ruffatti A, Minervini L, Romano M, Sonino N. Galactorrhea with aripiprazole. Psychother Psychosom. 2005;74:391-2. [PubMed: 16244518]
19.
Gunes S. Hyperprolactinemic galactorrhea as a side effect of aripiprazolean adolescent case (aripiprazole-related hyperprolactinemic galactorrhea). J Clin Psychopharmacol. 2018;38:161-2. [PubMed: 29360652]
20.
Suzuki H, Hibino H, Inoue Y et al. A patient with schizophrenia who lactated owing to mastopathy during aripiprazole once-monthly 300 mg treatment. Int Med J: IMJ. 2018;25:90-1.
21.
Guler G, Kutuk MO, Kara H. Amenorrhea as a side effect of low dose aripiprazole: An adolescent case. Clin Psychopharmacol Neurosci. 2018;16:343-5. [PMC free article: PMC6124876] [PubMed: 30121986]
22.
Yskes R, Thomas R, Nagalla ML. A case of decreased milk production associated with aripiprazole. Prim Care Companion CNS Disord. 2018;20:18l02303. [PubMed: 30549496]
23.
Walker T, Coursey C, Duffus ALJ. Low dose of Abilify (aripiprazole) in combination with Effexor XR (venlafaxine HCl) resulted in cessation of lactation. Clin Lact. 2019;10:56-9. DOI: 10.1891/2158-0782.10.2.56. [CrossRef]
24.
Mendhekar D, Sunder KR, Andrade C. Aripiprazole use in a pregnant schizoaffective woman. Bipolar Disord. 2006;8:299-300. [PubMed: 16696834]
25.
Frew JR. Psychopharmacology of bipolar I disorder during lactation: a case report of the use of lithium and aripiprazole in a nursing mother. Arch Womens Ment Health. 2015;18:135-6. [PubMed: 25352315]
26.
Lozano R, Marin R, Santacruz MJ. Prolactin deficiency by aripiprazole. J Clin Psychopharmacol. 2014;34:539-40. [PubMed: 24911440]
27.
Luo T, Liu QS, Yang YJ et al. Aripiprazole for the treatment of duloxetine-induced hyperprolactinemia: A case report. J Affect Disord. 2019;250:330-3. [PubMed: 30875676]

Substance Identification

Substance Name

Aripiprazole

CAS Registry Number

129722-12-9

Drug Class

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site .

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