{
 "query": "lurasidone",
 "ingredient": "lurasidone",
 "slug": "lurasidone",
 "rxcui": "1040028",
 "brands": [
  "Latuda"
 ],
 "names": [
  "lurasidone",
  "lurasidone hydrochloride"
 ],
 "classes": [
  {
   "id": "N05AE",
   "name": "Indole derivatives"
  }
 ],
 "alternatives": [
  "molindone",
  "oxypertine",
  "sertindole",
  "ziprasidone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37
  },
  "boxed_warning": "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 an increased risk of death. LATUDA 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 ). 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. LATUDA 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...",
  "indications_and_usage": "is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate ( 1 , 14.2 )",
  "contraindications": "Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions ( 6.1 )] . Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ( 7.1 )]. Known hypersensitivity to LATUDA or any components in the formulation ( 4 ). Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) ( 2.6 , 4 , 7.1 ). Concomitant use with a strong CYP3A4 inducer (e.g., rifampin) ( 2.6 , 4 , 7.1 ).",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) ( 5.3 ). Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ). Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ). Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.6 ). Hyperprolactinemia: Prolactin elevations may occur ( 5.7 ). Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing LATUDA if a clinically significant decline in WBC occurs in the absence of other causative factors ( 5.8 ). Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.9 ). 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an...",
  "warnings": "",
  "adverse_reactions": "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 )] Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warn...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance LATUDA is not a controlled substance. 9.2 Abuse LATUDA has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with LATUDA did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of LATUDA misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).",
  "controlled_substance": "9.1 Controlled Substance LATUDA is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.7 ) 1/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behavior Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions ( 5.2 )] . Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as Neuroleptic Malignant Syndrome (NMS). Advise patients, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions ( 5.4 )] . Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions ( 5.5 )] . Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions ( 5.6 )] . Hy...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration . Revised: 1/2025 MEDICATION GUIDE LATUDA (luh-TOO-duh) (lurasidone hydrochloride) tablets What is the most important information I should know about LATUDA? LATUDA may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. Medicines like LATUDA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LATUDA is not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suici...",
  "clinical_studies": "14.1 Schizophrenia Adults The efficacy of LATUDA for the treatment of schizophrenia was established in five short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.4 years, range 18-72) who met DSM-IV criteria for schizophrenia. An active-control arm (olanzapine or quetiapine extended-release) was included in two studies to assess assay sensitivity. Several instruments were used for assessing psychiatric signs and symptoms in these studies: Positive and Negative Syndrome Scale (PANSS), is a multi-item inventory of general psychopathology used to evaluate the effects of drug treatment in schizophrenia. PANSS total scores may range from 30 to 210. Brief Psychiatric Rating Scale derived (BPRSd), derived from the PANSS, is a multi-item inventory primarily focusing on positive symptoms of schizophrenia, whereas the PANSS includes a wider range of positive, negative and other symptoms of schizophrenia. The BPRSd consists of 18 items rated on a scale of 1 (not present) to 7 (severe). BPRSd scores may range from 18 to 126. The Clinical Global Impression severity scale (CGI-S) is a clinician-rated scale that measures the subject's current illness state on a 1- to 7...",
  "brand_name": "Latuda",
  "manufacturer": "Sumitomo Pharma America, Inc.",
  "application_number": "NDA200603",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250131",
  "set_id": "afad3051-9df2-4c54-9684-e8262a133af8",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 22504,
  "serious": 10760,
  "death": 900,
  "hospitalization": 3756,
  "primary_suspect": 22436,
  "top_reactions": [
   [
    "Off Label Use",
    2208
   ],
   [
    "Drug Ineffective",
    2155
   ],
   [
    "Anxiety",
    1297
   ],
   [
    "Depression",
    1221
   ],
   [
    "Weight Increased",
    1199
   ],
   [
    "Feeling Abnormal",
    1168
   ],
   [
    "Somnolence",
    1129
   ],
   [
    "Nausea",
    1117
   ],
   [
    "Insomnia",
    1038
   ],
   [
    "Suicidal Ideation",
    1026
   ],
   [
    "Fatigue",
    1001
   ],
   [
    "Dyskinesia",
    853
   ],
   [
    "Suicide Attempt",
    808
   ],
   [
    "Tremor",
    742
   ],
   [
    "Vomiting",
    712
   ]
  ],
  "by_year": {
   "2019": 3265,
   "2020": 2565,
   "2021": 3049,
   "2022": 2049,
   "2023": 1358,
   "2024": 1040,
   "2025": 921,
   "2026": 447
  },
  "by_year_primary": {
   "2019": 3264,
   "2020": 2562,
   "2021": 3040,
   "2022": 2031,
   "2023": 1353,
   "2024": 1036,
   "2025": 901,
   "2026": 439
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 21,
  "nda": 1,
  "anda": 19,
  "first_approval": "20101028",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS CO",
   "ANNORA PHARMA",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX",
   "DR REDDYS"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/28/2010"
 },
 "trials": {
  "total": 100,
  "completed": 76,
  "terminated": 10,
  "with_results": 51,
  "industry": 79,
  "phase3": 41,
  "results_share": 0.6710526315789473,
  "terminated_share": 0.1
 },
 "pubmed": {
  "rct": 77,
  "meta": 24,
  "recent_rct": 19,
  "cochrane": [
   {
    "pmid": "39831535",
    "title": "Lurasidone versus typical antipsychotics for schizophrenia",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 18128.8,
  "records": 22,
  "by_name": [
   [
    "Latuda",
    18128.8
   ]
  ],
  "names_checked": [
   "lurasidone",
   "Latuda"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 853871,
  "beneficiaries": 124175,
  "spend": 222296493.77999997,
  "by_brand": [
   {
    "brand": "Lurasidone HCl",
    "claims": 829678,
    "per_claim": 220.14994961,
    "is_generic": true
   },
   {
    "brand": "Latuda",
    "claims": 24193,
    "per_claim": 1638.6113293,
    "is_generic": false
   }
  ],
  "per_claim": 260.3396693177306
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2376,
  "fills": 853871,
  "per_million": 2782.6217309171993,
  "ratio": 1.004937603908501,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,783 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "77 randomized trials and 24 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 19 generic makers (-3)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $18,129 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (19 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are anxiety, depression. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over molindone, oxypertine, sertindole? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}