Aripiprazole

DRUG INFORMATION

  ADULT
    - Aripiprazole has been systematically evaluated and shown to be effective in a dose
      range of 10 to 30 mg/day, when administered as the tablet formulation; however,
      doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day.
      Source: US FDA label for aripiprazole (aripiprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - These patients were discontinued from those medications and randomized to either
      aripiprazole 15 mg/day or placebo, and observed for relapse [see Clinical Studies
      (14.1)] .
      Source: US FDA label for aripiprazole (aripiprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - The starting daily dose of the tablet formulation in these patients was 2 mg,
      which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2
      additional days.
      Source: US FDA label for aripiprazole (aripiprazole), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients with major depressive disorder or
      agitation associated with schizophrenia or bipolar mania have not been
      established. The pharmacokinetics of aripiprazole and dehydro-aripiprazole in
      pediatric patients, 10 to 17 years of age, were similar to those in adults after
      correcting for the differences in body weight [see Clinical Pharmacology ( 12.3
      )].
      Source: US FDA label for aripiprazole (aripiprazole), section 'pediatric use',
      retrieved 2026-08-29
    - Schizophrenia Adults The recommended starting and target dose for aripiprazole
      oral solution is 10 or 15 mg/day administered on a once-a-day schedule without
      regard to meals. Aripiprazole has been systematically evaluated and shown to be
      effective in a dose range of 10 to 30 mg/day, when administered as the tablet
      formulation; however, doses higher than 10 or 15 mg/day were not more effective
      than 10 or 15 mg/day.
      Source: US FDA label for aripiprazole (aripiprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - Adolescents The recommended target dose of aripiprazole oral solution is 10
      mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with
      schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the
      tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2
      days and to the target dose of 10 mg after 2 additional days. Subsequent dose
      increases should be administered in 5 mg increments.
      Source: US FDA label for aripiprazole (aripiprazole), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Approximately 8% of Caucasians and 3 to 8% of Black/African Americans cannot
      metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [ see
      Dosage and Administration ( 2.7 ) and Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - Hepatic and Renal Impairment No dosage adjustment for aripiprazole is required on
      the basis of a patient’s hepatic function (mild to severe hepatic impairment,
      Child-Pugh score between 5 and 15), or renal function (mild to severe renal
      impairment, glomerular filtration rate between 15 and 90 mL/minute) [see Clinical
      Pharmacology ( 12.3 )].
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Approximately 8% of Caucasians and 3 to 8% of Black/African Americans cannot
      metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [ see
      Dosage and Administration ( 2.7 ) and Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - Hepatic and Renal Impairment No dosage adjustment for aripiprazole is required on
      the basis of a patient’s hepatic function (mild to severe hepatic impairment,
      Child-Pugh score between 5 and 15), or renal function (mild to severe renal
      impairment, glomerular filtration rate between 15 and 90 mL/minute) [see Clinical
      Pharmacology ( 12.3 )].
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to atypical antipsychotics, including
      aripiprazole, during pregnancy.
      Source: US FDA label for aripiprazole (aripiprazole), section 'pregnancy',
      retrieved 2026-08-29
    - Healthcare providers are encouraged to register patients by contacting the
      National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit
      http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
      Source: US FDA label for aripiprazole (aripiprazole), section 'pregnancy',
      retrieved 2026-08-29
    - Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole,
      during the third trimester of pregnancy are at risk for extrapyramidal and/or
      withdrawal symptoms following delivery ( see Clinical Considerations ).
      Source: US FDA label for aripiprazole (aripiprazole), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with
      third trimester exposure (8.1) Lactation: Monitor the breastfed infant for
      dehydration and lack of appropriate weight gain ( 8.2 ). 8.1 Pregnancy Pregnancy
      Exposure Registry There is a pregnancy exposure registry that monitors pregnancy
      outcomes in women exposed to atypical antipsychotics, including aripiprazole,
      during pregnancy.
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - In rats injected intravenously with aripiprazole from gestation day 6 through
      lactation day 20 at doses of 3, 8, and 20 mg/kg/day, which are 1, 3, and 6 times
      the MRHD of 30 mg/day based on mg/m 2 body surface area, increased stillbirths
      were observed at 3 and 6 times the MRHD; and decreases in early postnatal pup
      weight and survival were observed at 6 times the MRHD; these doses also caused
      some maternal toxicity.
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - There were no effects on postnatal behavioral and reproductive development. 8.2
      Lactation Risk Summary Aripiprazole is present in human breast milk.
      Source: US FDA label for aripiprazole (aripiprazole), section 'use in specific
      populations', retrieved 2026-08-29