Aripiprazole

The mechanism of action of aripiprazole in schizophrenia is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

• Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic.ICD-10: F20.9

• Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2)].contraindicated

Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults (2.1) 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents (2.1) 2 mg/day 10 mg/day 30 mg/day Irritability associated with autistic disorder – pediatric patients (2.4) 2 mg/day 5 to 10 mg/day 15 mg/day Tourette’s disorder – (2.5) Patients <50 kg 2 mg/day 5 mg/day 10 mg/day Patients ≥50 kg 2 mg/day 10 mg/day 20 mg/day •Oral formulations: Administer once daily without regard to meals (2) •Known CYP2D6 poor metabolizers: Half of the usual dose (2.7) 2.1 Schizophrenia Adults The recommended starting and target dose for aripiprazole 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. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see Clinical Studies (14.1)] . Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. 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)] . Patients should be periodically reassessed to determine the continued need for maintenance treatment.

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) (5.2) • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4) • Tardive Dyskinesia: Discontinue if clinically appropriate (5.5) • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain (5.6) o Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes (5.6) o Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics (5.6) o Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight (5.6) • Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation (5.7) • Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.8) • Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including aripiprazole.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1)] • Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2)] • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3)] • Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4)] • Tardive Dyskinesia [see Warnings and Precautions (5.5)] • Metabolic Changes [see Warnings and Precautions (5.6)] • Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7)] • Orthostatic Hypotension [see Warnings and Precautions (5.8)] • Falls [see Warnings and Precautions (5.9)] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10)] • Seizures/Convulsions [see Warnings and Precautions (5.11)] • Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12)] • Body Temperature Regulation [see Warnings and Precautions (5.13)] • Suicide [see Warnings and Precautions (5.14)] • Dysphagia [see Warnings and Precautions (5.15)] The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, co…

Pregnancy : May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure (8.1) 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. 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/ . 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) . Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother associated with untreated schizophrenia, bipolar I disorder, or major depressive disorder, and with exposure to antipsychotics, including aripiprazole, during pregnancy (see Clinical Considerations).

Metabolism

Aripiprazole activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D 2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma. The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively.

MedDRA terminology has been used to classify the adverse reactions. 10.1 Human Experience In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral aripiprazole have been reported worldwide. These include overdoses with oral aripiprazole alone and in combination with other substances. No fatality was reported with aripiprazole alone. The largest known dose with a known outcome involved acute ingestion of 1,260 mg of oral aripiprazole (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 years and younger) involving oral aripiprazole ingestions up to 195 mg with no fatalities. Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor.

• Nov 15, 2002NDANDA021436Otsuka
• Feb 28, 2013NDANDA202971Otsuka Pharm Co Ltd
• Apr 28, 2015ANDAANDA202102Alembic
• Apr 28, 2015ANDAANDA202101Alembic
• Oct 5, 2015NDANDA207533Alkermes Inc
• Jun 29, 2018NDANDA209830Alkermes Inc
• Apr 27, 2023NDANDA217006Otsuka
• Jul 22, 2024NDANDA216655Xiamen Lp Pharm Co

1. 1Off Label Use8,4286.8%
2. 2Drug Ineffective8,4136.8%
3. 3Weight Increased7,9306.4%
4. 4Product Use In Unapproved Indication5,3014.3%
5. 5Anxiety5,1764.2%
6. 6Fatigue4,3663.5%
7. 7Depression4,0923.3%
8. 8Suicidal Ideation4,0833.3%
9. 9Nausea4,0343.3%
10. 10Insomnia3,9283.2%
11. 11Tremor3,7393.0%
12. 12Drug Interaction3,6502.9%
13. 13Somnolence3,6012.9%
14. 14Suicide Attempt3,5662.9%
15. 15Dizziness3,2372.6%

Recent PubMed references pinned to Aripiprazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Aripiprazole Once-Monthly for Patients Diagnosed With Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed.
  The Journal of clinical psychiatry · 2026 · Citrome L, Bell Lynum KS, Zhang Z, et al.
  PMID 42138587DOI 10.4088/JCP.26m16359
• [Effect of aripiprazole on cytokine production by T cells in schizophrenia].
  Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova · 2026 · Chugunov DA, Sviridova AA, Lopatina AV, et al.
  PMID 42133420DOI 10.17116/jnevro202612604189
• The Antipsychotic Aripiprazole Induces Cytotoxicity in Bladder Cancer Cells While Preserving Urothelial and Bladder Function.
  Pharmacology research & perspectives · 2026 · O'Callaghan LA, Powell K, Chess-Williams R, et al.
  PMID 42087358DOI 10.1002/prp2.70260
• Three-week effect of amisulpride, aripiprazole, and olanzapine on gene expression in peripheral blood in individuals with schizophrenia spectrum disorders.
  The international journal of neuropsychopharmacology · 2026 · Torsvik A, Trentani A, Stokowy TK, et al.
  PMID 42033308DOI 10.1093/ijnp/pyag019
• Quality of life in early-phase schizophrenia patients starting treatment with long-acting injectable vs. oral antipsychotic drugs: Data from the European Long-acting Antipsychotics in Schizophrenia Trial (EULAST).
  European psychiatry : the journal of the Association of European Psychiatrists · 2026 · Schulze AT, Tschiderer L, Post F, et al.
  PMID 42011073DOI 10.1192/j.eurpsy.2026.12209
• Development and validation of a precision treatment rules for first-line antipsychotic recommendations in first episode psychosis jointly incorporating effectiveness, side effects and patient preferences.
  Translational psychiatry · 2026 · Krakowski K, Oliver D, Arribas M, et al.
  PMID 41965367DOI 10.1038/s41398-026-03914-w
• Safety and Efficacy of Maintenance Treatment With Aripiprazole Once-Monthly in Black/African American Adults Diagnosed With Bipolar I Disorder: Post Hoc Analysis of a 52-Week, Open-Label Study.
  The Journal of clinical psychiatry · 2026 · Bell Lynum KS, Such P, Zhang Z, et al.
  PMID 41944742DOI 10.4088/JCP.25m16114
• The association between body mass index and treatment outcomes in major depressive disorder: a CAN-BIND-1 study.
  Journal of psychiatric research · 2026 · Kim HK, Jones BDM, Hahn MK, et al.
  PMID 41935494DOI 10.1016/j.jpsychires.2026.03.036

The 10 most recently updated of 460 ClinicalTrials.gov registrations naming Aripiprazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Biomarkers to Enhance Early Schizophrenia Treatment
  Recruiting · Phase 4 · Interventional · 180 enrolled · Northwell Health
  NCT06969755updated 2026-06-12
• Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole
  Active not recruiting · Interventional · 108 enrolled · Central South University
  NCT06937476updated 2026-06-12
• Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
  Completed · Phase 3 · Interventional · 937 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT00706654updated 2026-06-04
• Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
  Recruiting · Phase 3 · Interventional · 380 enrolled · Minerva Neurosciences
  NCT07565428updated 2026-05-28
• Cerebellum-based Imaging Neural Markers for Antipsychotic Response
  Recruiting · Phase 4 · Interventional · 120 enrolled · Northwell Health
  NCT07483294updated 2026-05-26
• Switching Medication to Treat Schizophrenia
  Completed · Phase 4 · Interventional · 219 enrolled · Icahn School of Medicine at Mount Sinai
  NCT00044655updated 2026-05-15
• Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
  Completed · Phase 3 · Interventional · 98 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT00332241updated 2026-05-13
• A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
  Completed · Phase 4 · Interventional · 1,169 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT00277212updated 2026-05-13
• Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
  Completed · Phase 3 · Interventional · 218 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT00337571updated 2026-05-13
• Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area
  Not yet recruiting · Interventional · 100 enrolled · University of Alabama at Birmingham
  NCT07570875updated 2026-05-06

CPIC-curated drug–gene pairs for Aripiprazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2D6CPIC B (provisional)ClinPGx 1AFDA label: Actionable PGx
• MC4RCPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Aripiprazole work?

The mechanism of action of aripiprazole in schizophrenia is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

What is Aripiprazole used for?

According to FDA labeling, Aripiprazole carries indications including: Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Aripiprazole?

Aripiprazole is classified as Other antipsychotics, Atypical Antipsychotic, Dopamine Receptor Interactions, Serotonin Receptor Interactions, Decreased Dopamine Activity, Decreased Serotonin Activity.

What are the brand names for Aripiprazole?

Aripiprazole is marketed under brand names including Abilify, Opipza.

What are the contraindications for Aripiprazole?

Aripiprazole labeling lists contraindications including: Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2)].. Always consult the full prescribing information and a clinician.