{
 "query": "cariprazine",
 "ingredient": "cariprazine",
 "slug": "cariprazine",
 "rxcui": "1667655",
 "brands": [
  "Vraylar"
 ],
 "names": [
  "cariprazine",
  "cariprazine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "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. VRAYLAR 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 behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of su...",
  "indications_and_usage": "1 . INDICATIONS AND USAGE VRAYLAR \u00ae is indicated for: \u2022 Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] \u2022 Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] \u2022 Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] \u2022 Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults and pediatric patients 13 years of age and older ( 1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older ( 1 ) Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults ( 1 ) Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 )",
  "contraindications": "4 . CONTRAINDICATIONS VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and reactions suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face). Known hypersensitivity to VRAYLAR ( 4 )",
  "warnings_and_cautions": "5 . WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) ( 5.3 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia : Discontinue if appropriate ( 5.5 ) Late-Occurring Adverse Reactions: Because of VRAYLAR\u2019s long half-life, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change ( 5.6 ) Metabolic Changes : Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.7 ) Leukopenia, Neutropenia, and Agranulocytosis : Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia. Consider discontinuing VRAYLAR if a clinically significant decline in WBC occurs in absence of other causative factors ( 5.8 ) Orthostatic H ypotension 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 ) Seizures: Use ...",
  "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 )] Late Occurring Adverse Reactions [see Warnings and Precautions ( 5.6 )] Metabolic Changes [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 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Most common adverse reac...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance VRAYLAR is not a controlled substance. 9.2 Abuse VRAYLAR has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance. 9.3 Dependence VRAYLAR has not been systematically studied in animals or humans for its potential for physical dependence.",
  "controlled_substance": "9.1 Controlled Substance VRAYLAR is not a controlled substance.",
  "recent_major_changes": "Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.2 , 2.3 , 2.6 ) 12/2025 Warnings and Precautions, Metabolic Changes ( 5.7 ) 12/2025",
  "information_for_patients": "Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to their healthcare provider [ see Box Warning and Warnings and Precautions ( 5.2 ) ] . Dosage and Administration Advise patients that VRAYLAR can be taken with or without food. Counsel them on the importance of following dosage escalation instructions [see Dosage and Administration ( 2 )]. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported in association with administration of antipsychotic drugs. 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 health care provider if these abnormal mov...",
  "spl_medguide": "MEDICATION GUIDE VRAYLAR \u00ae (VRAY-lar) (cariprazine) capsules What is the most important information I should know about VRAYLAR? VRAYLAR may cause serious side effects, including : Increased risk of death in elderly people with dementia related psychosis. Medicines like VRAYLAR can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Increased risk of suicidal thoughts and actions. VRAYLAR and antidepressant medicines increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. \u25cb Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? \u25cb Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant medicine is started or when the dose is changed. \u25cb Call the healthcare provider ri...",
  "clinical_studies": "Figure 2. Change from Baseline in PANSS total score by weekly visits (Study 2) Figure 3. Kaplan-Meier Curves of Cumulative Rate of Relapse During the Double-Blind Treatment Period Figure 3 Figure 4. Change from Baseline in YMRS total score by study visit (Study 4) Figure 5. LS Mean* Change from Baseline in MADRS Total Score by Visits (Study 8) Figure 6. LS Mean\u2021 Change from Baseline to Week 6 in MADRS Total Score in Adjunctive Treatment of Major Depressive Disorder (Study 10) 14.1 Schizophrenia The efficacy of VRAYLAR for the treatment of schizophrenia in adult patients was established in three, 6-week, randomized, double-blind, placebo-controlled trials in patients (mean age of 37 years, aged 18 to 60 years; 31% were female; and 45% were Caucasian) who met Diagnostic and Statistical Manual of Mental Disorders 4 th edition, Text Revision (DSM-IV-TR) criteria for schizophrenia. An active control arm (risperidone or aripiprazole) was included in two trials to assess assay sensitivity. In all three trials, VRAYLAR was superior to placebo. Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions-Severity (CGI-S) rating scales were used as the primary and secondary e...",
  "brand_name": "Vraylar",
  "manufacturer": "Allergan, Inc.",
  "application_number": "NDA204370",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251218",
  "set_id": "4b5f7c65-aa2d-452a-b3db-bc85c06ff12f",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9674,
  "serious": 3611,
  "death": 266,
  "hospitalization": 1401,
  "primary_suspect": 9600,
  "top_reactions": [
   [
    "Off Label Use",
    1104
   ],
   [
    "Drug Ineffective",
    558
   ],
   [
    "Weight Increased",
    486
   ],
   [
    "Akathisia",
    441
   ],
   [
    "Anxiety",
    390
   ],
   [
    "Tremor",
    380
   ],
   [
    "Tardive Dyskinesia",
    379
   ],
   [
    "Nausea",
    368
   ],
   [
    "Fatigue",
    363
   ],
   [
    "Insomnia",
    349
   ],
   [
    "Suicidal Ideation",
    340
   ],
   [
    "Dizziness",
    289
   ],
   [
    "Depression",
    287
   ],
   [
    "Somnolence",
    257
   ],
   [
    "Feeling Abnormal",
    232
   ]
  ],
  "by_year": {
   "2019": 952,
   "2020": 1129,
   "2021": 936,
   "2022": 905,
   "2023": 1325,
   "2024": 1310,
   "2025": 1532,
   "2026": 661
  },
  "by_year_primary": {
   "2019": 951,
   "2020": 1128,
   "2021": 930,
   "2022": 887,
   "2023": 1319,
   "2024": 1295,
   "2025": 1506,
   "2026": 660
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 4,
  "nda": 1,
  "anda": 3,
  "first_approval": "20150917",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 1,
  "sponsors": [
   "ABBVIE",
   "AUROBINDO PHARMA LTD",
   "SUN PHARM",
   "ZYDUS"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/17/2015"
 },
 "trials": {
  "total": 55,
  "completed": 34,
  "terminated": 7,
  "with_results": 24,
  "industry": 41,
  "phase3": 23,
  "results_share": 0.7058823529411765,
  "terminated_share": 0.12727272727272726
 },
 "pubmed": {
  "rct": 43,
  "meta": 23,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 19742693.99,
  "records": 395929,
  "by_name": [
   [
    "Vraylar",
    19742693.99
   ]
  ],
  "names_checked": [
   "cariprazine",
   "Vraylar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 766962,
  "beneficiaries": 117573,
  "spend": 1135973310.0,
  "by_brand": [
   {
    "brand": "Vraylar",
    "claims": 766962,
    "per_claim": 1481.133759,
    "is_generic": false
   }
  ],
  "per_claim": 1481.133758908525
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3461,
  "fills": 766962,
  "per_million": 4512.609490431078,
  "ratio": 1.6297188073758742,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 61,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "4,513 FDA reports naming it as the suspect drug per million Medicare fills, 1.6x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (0.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 54,
   "letter": "D",
   "why": [
    "43 randomized trials and 23 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $19,742,694 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (3 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 64,
 "grade": "C",
 "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 weight increased, akathisia. 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}