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    DEA Class;  Rx

    Common Brand Names; Rexulti

    • Serotonin-Dopamine Activity Modulators (SDAM)
    Oral atypical antipsychotic of dopamine system stabilizers subclass
    Used as adjunctive treatment for adults with major depressive disorder (MDD) or as monotherapy for schizophrenia in adolescents (13 to 17 years old) and adults; review clinically significant drug interactions
    Boxed warning related to an increased risk of suicidality in children, adolescents, and young adults, as well as regarding increased mortality risk in elderly patients treated for dementia-related psychosis

    Indicated for treatment of schizophrenia

    Indicated an adjunctive therapy to antidepressants for major depressive disorder (MDD)

    Hypersensitivity to brexpiprazole or any of its components; reactions have included rash, facial swelling, urticaria, and angioedema

    • Akathisia (4-14%)
    • Headache (4-9%)
    • Increased weight (6-8%)
    • Nasopharyngitis (3-7%)
    • Somnolence (4-6%)
    • Fatigue (3-5%)
    • Tremor (2-5%)
    • Dizziness (1-5%)
    • Blood cortisol decreased (3-4%)
    • Anxiety (2-4%)
    • Restlessness (2-4%)
    • Increased appetite (2-3%)
    • Constipation (1-3%)

    Schizophrenia (adults)

    • Akathisia (4-7%)
    • Dyspepsia (2-6%)
    • Increased weight (3-4%)
    • Blood creatinine phosphokinase increased (3-4%)
    • Tremor (2-3%)
    • Sedation (2-3%)
    • Diarrhea (1-3%)

    Increased mortality in elderly patients with dementia-related psychosis; in placebo-controlled trials, majority of patients treated with atypical antipsychotic drugs had a 1.6-1.7x higher risk of death than placebo

    Suicidal thoughts and behaviors reported in patients ≤24 years who are taking antidepressant drugs; unknown whether risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use (ie, >4 months)

    May cause leukopenia, neutropenia, and agranulocytosis; monitor and discontinue if severe neutropenia (ANC <1000/mm3); in patients with a pre-existing low WBC or ANC or a history of drug-induced leukopenia or neutropenia, perform a complete blood cell count (CBC) frequently during the first few months of therapy

    Orthostatic hypotension or syncope may occur; the risk is greatest during initial dose titration and when increasing the dose; monitor orthostatic vital signs in patients who are vulnerable to hypotension, (eg, elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medication, patients with known cardiovascular disease, patients with cerebrovascular disease)

    May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

    Caution with a history of seizures or with conditions/drugs that potentially lower the seizure threshold

    May disrupt the body’s ability to reduce core body temperature; use with caution in patients who experience these conditions

    Esophageal dysmotility and aspiration pneumonia reported; use cautiously in patients at risk for aspiration

    Adequate and well-controlled studies have not been conducted with brexpiprazole in pregnant females inform drug-associated risks

    Unknown if distributed in human breast milk

    Present in rat milk

    The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition


    4 mg/day PO.


    4 mg/day PO.


    4 mg/day PO.


    Safety and efficacy have not been established.


    Not indicated.


    Not indicated.



    • 0.25mg
    • 0.5mg
    • 1mg
    • 2mg
    • 3mg
    • 4mg