{
 "query": "quetiapine",
 "ingredient": "quetiapine",
 "slug": "quetiapine",
 "rxcui": "51272",
 "brands": [
  "Seroquel"
 ],
 "names": [
  "quetiapine",
  "quetiapine fumarate"
 ],
 "classes": [
  {
   "id": "N05AH",
   "name": "Diazepines, oxazepines, thiazepines and oxepines"
  }
 ],
 "alternatives": [
  "asenapine",
  "clothiapine",
  "clozapine",
  "loxapine",
  "olanzapine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 147
  },
  "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 [ see Warnings and Precautions (5.1) ] . Quetiapine 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 children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.2) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.2) ]. Que...",
  "indications_and_usage": "Quetiapine fumarate tablet is an atypical antipsychotic indicated for the treatment of: \u2022 Schizophrenia ( 1.1 ) \u2022 Bipolar I disorder manic episodes ( 1.2 ) \u2022 Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)] 1.2 Bipolar Disorder Quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12- week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2)] . Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with b...",
  "contraindications": "Hypersensitivity to quetiapine or to any excipients in the quetiapine fumarate tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine fumarate tablets. Known hypersensitivity to quetiapine or any components in the formulation.",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( Error! Hyperlink reference not valid. ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. ( Error! Hyperlink reference not valid. ) Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5 ) Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended Tardive Dyskinesia: Discontinue if clinical...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: \u2022 Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1)] \u2022 Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2)] \u2022 Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3)] \u2022 Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4)] \u2022 Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5)] \u2022 Tardive dyskinesia [see Warnings and Precautions (5.6)] \u2022 Hypotension [see Warnings and Precautions (5.7)] \u2022 Increases in blood pressure (children and adolescents) [see Warnings and Precautions (5.8)] \u2022 Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions (5.9)] \u2022 Cataracts [see Warnings and Precautions (5.10)] \u2022 QT Prolongation [see Warnings and Precautions (5.11)] \u2022 Seizures [see Warnings and Precautions (5.12)] \u2022 Hypothyroidism [see Warnings and Precautions (5.13)] \u2022 Hyperprolactinemia [see Warnings and Precautions (5.14)] \u2022 Potential for ...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Quetiapine is not a controlled substance. 9.2 Abuse Quetiapine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of quetiapine, e.g., development of tolerance, increases in dose, drug-seeking behavior.",
  "controlled_substance": "9.1 Controlled Substance Quetiapine is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions, Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis ( Error! Hyperlink reference not valid. ) 4/2013",
  "information_for_patients": "See FDA-approved patient labeling (Medication Guide) Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine and should counsel them in its appropriate use. A patient Medication Guide about \u201cAntidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions\u201d is available for quetiapine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at in...",
  "spl_medguide": "MEDGUIDE SECTION Medication Guide Quetiapine Fumarate Tablets Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about quetiapine fumarate tablets? Quetiapine fumarate tablets may cause serious side effects, including: 1. risk of death in the elderly with dementia: Medicines like quetiapine fumarate tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate tablet is not for treating psychosis in the elderly with dementia. 2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions). Talk to your, or your family member\u2019s, healthcare provider about: \u2022 all risks and benefits of treatment with antidepressant medicines. \u2022 all treatment choices for depression or other serious mental illness. Antidepressant medications may increase suicidal thoughts or actions in some children, teenager...",
  "clinical_studies": "14.1 Schizophrenia Short-term Trials - Adults The efficacy of quetiapine in the treatment of schizophrenia was established in 3 short-term (6-week) controlled trials of inpatients with schizophrenia who met DSM III-R criteria for schizophrenia. Although a single fixed dose haloperidol arm was included as a comparative treatment in one of the three trials, this single haloperidol dose group was inadequate to provide a reliable and valid comparison of quetiapine and haloperidol. Several instruments were used for assessing psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale (BPRS), a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the pa...",
  "brand_name": "Quetiapine fumarate",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA202152",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221001",
  "set_id": "1a147d6c-8af8-4379-8a13-1864a9a79b84",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 135682,
  "serious": 115334,
  "death": 21682,
  "hospitalization": 56864,
  "primary_suspect": 133848,
  "top_reactions": [
   [
    "Drug Ineffective",
    11061
   ],
   [
    "Off Label Use",
    10364
   ],
   [
    "Toxicity To Various Agents",
    9577
   ],
   [
    "Fatigue",
    7600
   ],
   [
    "Drug Interaction",
    7211
   ],
   [
    "Nausea",
    6483
   ],
   [
    "Somnolence",
    6353
   ],
   [
    "Pain",
    6025
   ],
   [
    "Anxiety",
    5671
   ],
   [
    "Condition Aggravated",
    5578
   ],
   [
    "Dizziness",
    5539
   ],
   [
    "Depression",
    5528
   ],
   [
    "Confusional State",
    5508
   ],
   [
    "Vomiting",
    5461
   ],
   [
    "Headache",
    5444
   ]
  ],
  "by_year": {
   "2019": 13317,
   "2020": 13313,
   "2021": 12510,
   "2022": 11311,
   "2023": 11094,
   "2024": 11895,
   "2025": 11608,
   "2026": 5664
  },
  "by_year_primary": {
   "2019": 13277,
   "2020": 13262,
   "2021": 12315,
   "2022": 10983,
   "2023": 10712,
   "2024": 11563,
   "2025": 11348,
   "2026": 5489
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20200227",
   "reason": "Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200227",
   "reason": "Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200227",
   "reason": "Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200227",
   "reason": "Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181114",
   "reason": "Presence of Foreign Substance; metal shard found in tablet",
   "firm": "Ascend Laboratories LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 41,
  "nda": 3,
  "anda": 38,
  "first_approval": "19970926",
  "rems": false,
  "rems_last": "20111109",
  "labeling_supplements": 54,
  "labeling_recent": 4,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS GRP PTC",
   "ALEMBIC",
   "ALICORA",
   "ALIGNSCIENCE PHARMA",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/26/1997"
 },
 "trials": {
  "total": 493,
  "completed": 349,
  "terminated": 68,
  "with_results": 122,
  "industry": 269,
  "phase3": 132,
  "results_share": 0.3495702005730659,
  "terminated_share": 0.13793103448275862
 },
 "pubmed": {
  "rct": 352,
  "meta": 53,
  "recent_rct": 35,
  "cochrane": [
   {
    "pmid": "24249315",
    "title": "Quetiapine versus other atypical antipsychotics for schizophrenia",
    "year": "2013"
   },
   {
    "pmid": "23728667",
    "title": "Quetiapine versus typical antipsychotic medications for schizophrenia",
    "year": "2013"
   },
   {
    "pmid": "20091600",
    "title": "Quetiapine versus other atypical antipsychotics for schizophrenia",
    "year": "2010"
   },
   {
    "pmid": "15106155",
    "title": "Quetiapine for schizophrenia",
    "year": "2004"
   },
   {
    "pmid": "10908478",
    "title": "Quetiapine for schizophrenia",
    "year": "2000"
   },
   {
    "pmid": "10796560",
    "title": "Quetiapine for schizophrenia",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 1782.42,
  "records": 101,
  "by_name": [
   [
    "Seroquel",
    1782.42
   ]
  ],
  "names_checked": [
   "quetiapine",
   "Seroquel"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9863943,
  "beneficiaries": 1488933,
  "spend": 208919256.63,
  "by_brand": [
   {
    "brand": "Quetiapine Fumarate",
    "claims": 9340374,
    "per_claim": 17.124386646,
    "is_generic": true
   },
   {
    "brand": "Quetiapine Fumarate ER",
    "claims": 504595,
    "per_claim": 64.983409526,
    "is_generic": false
   },
   {
    "brand": "Seroquel",
    "claims": 11938,
    "per_claim": 728.53394371,
    "is_generic": false
   },
   {
    "brand": "Seroquel XR",
    "claims": 7036,
    "per_claim": 1063.6070338,
    "is_generic": false
   }
  ],
  "per_claim": 21.180095690942252
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2010,
   "company": "AstraZeneca",
   "amount_usd": 520000000.0,
   "amount_text": "$520 million",
   "violations": "Off-label promotion, kickbacks",
   "products": "Seroquel",
   "laws": "False Claims Act",
   "urls": [
    "https://www.justice.gov/opa/pr/2010/April/10-civ-487.html"
   ],
   "matched": "seroquel"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "quetiapine",
  "matched": "quetiapine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 28400,
  "fills": 9863943,
  "per_million": 2879.1731663494,
  "ratio": 1.039806938500084,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 62,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,879 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-3)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "352 randomized trials and 53 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "6 independent Cochrane review(s) exist",
    "Only 35% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 4 Class III across 38 generic makers (-3)",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Maker paid $520 million in 2010 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-15)",
    "Pharma paid doctors $1,782 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 (38 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "The maker paid $520 million in 2010 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "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 toxicity to various agents, fatigue. 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 asenapine, clothiapine, clozapine? 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.)"
 ]
}