{
 "query": "olanzapine",
 "ingredient": "olanzapine",
 "slug": "olanzapine",
 "rxcui": "61381",
 "brands": [
  "Zyprexa"
 ],
 "names": [
  "olanzapine",
  "olanzapine pamoate",
  "olanzapine pamoate monohydrate"
 ],
 "classes": [
  {
   "id": "N05AH",
   "name": "Diazepines, oxazepines, thiazepines and oxepines"
  }
 ],
 "alternatives": [
  "asenapine",
  "clothiapine",
  "clozapine",
  "loxapine",
  "quetiapine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 85,
   "INTRAMUSCULAR": 13
  },
  "boxed_warning": "WARNING: 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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine tablets are not approved for the treatment o...",
  "indications_and_usage": "Olanzapine Tablets, USP are an atypical antipsychotic indicated: As oral formulation for the: \u2022 Treatment of schizophrenia. ( 1.1 ) \u2022 Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) \u2022 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) \u2022 Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) \u2022 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2 ) \u2022 Efficacy was established in two 6-week clinical trials in adults ( 14.2 ). Maintenance efficacy has not been systematically evaluated. As olanzapine tablets and fluoxetine in combination for the: \u2022 Treatment of depressive episodes associated with bipolar I disorder. ( 1.5 ) \u2022 Efficacy was established with Symbyax \u00ae (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax \u00ae . 1.1 Schizophrenia Olanzapine Tablets, USP are indicated for the...",
  "contraindications": "\u2022 None with olanzapine tablets monotherapy. \u2022 When using olanzapine tablets and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax \u00ae . \u2022 For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. \u2022 None with olanzapine tablets monotherapy. \u2022 When using olanzapine tablets and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax \u00ae . ( 4 ) \u2022 When using olanzapine tablets in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ( 4 )",
  "warnings_and_cautions": "When using olanzapine tablets and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax \u00ae . \u2022 Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). ( 5.1 ) \u2022 Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax \u00ae . ( 5.2 ) \u2022 Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.3 ) \u2022 Hyperglycemia: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients taking olanzapine. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment. ( 5.4 ) \u2022 Hyperlipidemia: Undesirable alterations in lipids have been observed. Appropriate clini...",
  "warnings": "",
  "adverse_reactions": "When using olanzapine tablets and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax \u00ae . Most common adverse reactions (\u22655% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: \u2022 Schizophrenia (Adults) \u2013 postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia ( 6.1 ) \u2022 Schizophrenia (Adolescents) \u2013 sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth ( 6.1 ) \u2022 Manic or Mixed Episodes, Bipolar I Disorder (Adults) \u2013 asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor ( 6.1 ) \u2022 Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) \u2013 sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity ( 6.1 ) Combination of Olanzapine Tablets and Lithium or Valproate: \u2022 Manic or Mixed Episodes, Bipolar I Disorder (Adults) \u2013 dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia ( 6.1 ) Olanzapine tablets and Fluoxetine in Comb...",
  "drug_abuse_and_dependence": "9.3 Dependence In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the maximum recommended human daily oral dose (20 mg) and rhesus monkeys administered oral doses up to 8 times the maximum recommended human daily oral dose on a mg/m 2 basis. Olanzapine has not been systematically studied in 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 olanzapine (e.g., development of tolerance, increases in dose, drug-seeking behavior).",
  "controlled_substance": "",
  "recent_major_changes": "\u2022 None",
  "information_for_patients": "See FDA-approved Medication Guide . Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking olanzapine tablets as monotherapy or in combination with fluoxetine. If you do not think you are getting better or have any concerns about your condition while taking olanzapine tablets, call your doctor. When using olanzapine tablets and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax \u00ae . 17.1 Information on Medication Guide Prescribers or other health professionals should inform patients, their families, and their caregivers about the potential benefits and potential risks associated with treatment with olanzapine tablets, and should counsel them in its appropriate use. A patient Medication Guide is available for olanzapine tablets. Prescribers or other health professionals 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. When ...",
  "spl_medguide": "Medication Guide Olanzapine Tablets, USP 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg Read the Medication Guide that comes with olanzapine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about olanzapine tablets. What is the most important information I should know about olanzapine tablets? Olanzapine tablets may cause serious side effects, including: \u2022 Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). \u2022 High blood sugar (hyperglycemia) . \u2022 High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17. \u2022 Weight gain, especially in teenagers age 13 to 17. These serious side effects are described below. \u2022 Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets are not approved for t...",
  "clinical_studies": "When using olanzapine tablets and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax \u00ae . 14.1 Schizophrenia Adults The efficacy of oral olanzapine in the treatment of schizophrenia was established in 2 short-term (6-week) controlled trials of adult inpatients who met DSM III-R criteria for schizophrenia. A single haloperidol arm was included as a comparative treatment in 1 of the 2 trials, but this trial did not compare these 2 drugs on the full range of clinically relevant doses for both. 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 manifesta...",
  "brand_name": "Olanzapine",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA090798",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20210101",
  "set_id": "e40d54bf-7334-4418-8a87-ff85941adec1",
  "has_boxed_warning": true,
  "boxed_labels": "81 of 81",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 80303,
  "serious": 68512,
  "death": 8533,
  "hospitalization": 35754,
  "primary_suspect": 79421,
  "top_reactions": [
   [
    "Drug Ineffective",
    6690
   ],
   [
    "Off Label Use",
    5410
   ],
   [
    "Weight Increased",
    4233
   ],
   [
    "Toxicity To Various Agents",
    3970
   ],
   [
    "Somnolence",
    3485
   ],
   [
    "Nausea",
    3395
   ],
   [
    "Drug Interaction",
    3339
   ],
   [
    "Fatigue",
    3143
   ],
   [
    "Anxiety",
    2682
   ],
   [
    "Vomiting",
    2631
   ],
   [
    "Suicide Attempt",
    2613
   ],
   [
    "Confusional State",
    2566
   ],
   [
    "Condition Aggravated",
    2505
   ],
   [
    "Sedation",
    2430
   ],
   [
    "Overdose",
    2274
   ]
  ],
  "by_year": {
   "2019": 7221,
   "2020": 6800,
   "2021": 6675,
   "2022": 7206,
   "2023": 6986,
   "2024": 7104,
   "2025": 7266,
   "2026": 3344
  },
  "by_year_primary": {
   "2019": 7212,
   "2020": 6783,
   "2021": 6623,
   "2022": 7035,
   "2023": 6817,
   "2024": 6906,
   "2025": 7123,
   "2026": 3242
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260827",
   "reason": "Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.",
   "firm": "Macleods Pharmaceuticals Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241125",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "Macleods Pharmaceuticals Ltd",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220216",
   "reason": "cGmp Deviations",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161013",
   "reason": "Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 52,
  "nda": 5,
  "anda": 46,
  "first_approval": "19960930",
  "rems": true,
  "rems_last": "20260507",
  "labeling_supplements": 95,
  "labeling_recent": 10,
  "sponsors": [
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "AM REGENT",
   "APOTEX INC",
   "ASPIRO",
   "AUROBINDO PHARMA LTD",
   "BARR LABS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/30/1996"
 },
 "trials": {
  "total": 565,
  "completed": 390,
  "terminated": 65,
  "with_results": 135,
  "industry": 271,
  "phase3": 151,
  "results_share": 0.34615384615384615,
  "terminated_share": 0.11504424778761062
 },
 "pubmed": {
  "rct": 724,
  "meta": 108,
  "recent_rct": 75,
  "cochrane": [
   {
    "pmid": "38958149",
    "title": "Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders",
    "year": "2024"
   },
   {
    "pmid": "30246876",
    "title": "Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults",
    "year": "2018"
   },
   {
    "pmid": "20238348",
    "title": "Olanzapine versus other atypical antipsychotics for schizophrenia",
    "year": "2010"
   },
   {
    "pmid": "19160237",
    "title": "Olanzapine in long-term treatment for bipolar disorder",
    "year": "2009"
   },
   {
    "pmid": "16625629",
    "title": "Risperidone versus olanzapine for schizophrenia",
    "year": "2006"
   },
   {
    "pmid": "15846745",
    "title": "Risperidone versus olanzapine for schizophrenia",
    "year": "2005"
   },
   {
    "pmid": "15846678",
    "title": "Olanzapine IM or velotab for acutely disturbed/agitated people with suspected serious mental illnesses",
    "year": "2005"
   },
   {
    "pmid": "15846619",
    "title": "Olanzapine for schizophrenia",
    "year": "2005"
   },
   {
    "pmid": "12918000",
    "title": "Olanzapine alone or in combination for acute mania",
    "year": "2003"
   },
   {
    "pmid": "12535408",
    "title": "Olanzapine for schizophrenia",
    "year": "2003"
   },
   {
    "pmid": "10796640",
    "title": "Olanzapine for schizophrenia",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "olanzapine",
   "Zyprexa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3990311,
  "beneficiaries": 606758,
  "spend": 126820610.41,
  "by_brand": [
   {
    "brand": "Olanzapine",
    "claims": 3741398,
    "per_claim": 24.224371965,
    "is_generic": true
   },
   {
    "brand": "Olanzapine ODT",
    "claims": 236870,
    "per_claim": 81.744241314,
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   },
   {
    "brand": "Zyprexa",
    "claims": 8883,
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   },
   {
    "brand": "Zyprexa Zydis",
    "claims": 1766,
    "per_claim": 1714.980402,
    "is_generic": false
   },
   {
    "brand": "Zyprexa Relprevv",
    "claims": 1394,
    "per_claim": 1030.3245122,
    "is_generic": false
   }
  ],
  "per_claim": 31.782136883566217
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160510",
   "title": "FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm499441.htm",
   "kind": "drug",
   "matched": "zyprexa"
  },
  {
   "date": "20150323",
   "title": "FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm439147.htm",
   "kind": "drug",
   "matched": "zyprexa"
  }
 ],
 "settlements": [
  {
   "year": 2009,
   "company": "Eli Lilly",
   "amount_usd": 1400000000.0,
   "amount_text": "$1.4 billion",
   "violations": "Off-label promotion",
   "products": "Zyprexa",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2009/January/09-civ-038.html"
   ],
   "matched": "zyprexa"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "olanzapine",
  "matched": "olanzapine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 17271,
  "fills": 3990311,
  "per_million": 4328.234064963858,
  "ratio": 1.5631320355448484,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 35,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)",
    "4,328 FDA reports naming it as the suspect drug per million Medicare fills, 1.6x the median drug on this site (-4)",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 70,
   "letter": "C",
   "why": [
    "724 randomized trials and 108 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "11 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": 73,
   "letter": "C",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 2 Class III across 46 generic makers (-4)",
    "REMS program in force (-10)",
    "10 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 75,
   "letter": "B",
   "why": [
    "Maker paid $1.4 billion in 2009 to settle federal allegations naming this drug (Off-label promotion) (-25)",
    "Pharma paid doctors $0 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 (46 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 62,
 "grade": "D",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis\u2026). Does that risk apply to me?",
  "The maker paid $1.4 billion in 2009 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?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are weight increased, toxicity to various agents. 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.)"
 ]
}