# Aripiprazole ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)