Last reviewed 2026-04-20 · How we verify

LURASIDONE HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults 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 )]. 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 an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 ).

Common side effects

• Akathisia
• Extrapyramidal symptoms
• Somnolence
• Nausea

Key clinical trials

• An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
• Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
• Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
• High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (PHASE4)
• Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (PHASE3)
• A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication (PHASE2)
• Lurasidone Non-Interventional Study in Schizophrenia Patients
• NRX-101 for Bipolar Depression With Subacute Suicidal Ideation (PHASE2, PHASE3)

Primary sources

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