Last reviewed 2026-04-20 · How we verify

Rexulti (BREXPIPRAZOLE)

At a glance

Approved indications

• Major depressive disorder
• Schizophrenia

Boxed warnings

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of REXULTI have not been established in pediatric patients with MDD. ( 5.2 , 8.4 ) Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Warnings and Precautions (5.1) ] . Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2) ] . The safety and effectiveness of REXULTI have not been established in pediatric patients with MDD [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] .

Common side effects

• Weight Increased
• Akathisia
• Nasopharyngitis
• Tremor
• Somnolence
• Headache
• Dyspepsia
• Diarrhea
• Fatigue
• Increased Appetite
• Restlessness
• Anxiety

Key clinical trials

• Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) (PHASE4)
• Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (PHASE1)
• Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia (PHASE3)
• Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole) (PHASE1)
• The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia. (PHASE1)
• National Pregnancy Registry for Psychiatric Medications
• Precision Care for Major Depressive Disorder (PHASE4)
• Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (PHASE3)

Patents

Primary sources

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Competitive intelligence

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