{
 "query": "haloperidol",
 "ingredient": "haloperidol",
 "slug": "haloperidol",
 "rxcui": "5093",
 "brands": [
  "Haldol"
 ],
 "names": [
  "haloperidol",
  "haloperidol decanoate",
  "haloperidol lactate"
 ],
 "classes": [
  {
   "id": "N05AD",
   "name": "Butyrophenone derivatives"
  }
 ],
 "alternatives": [
  "benperidol",
  "bromperidol",
  "droperidol",
  "lumateperone",
  "metylperon",
  "pipamperone",
  "trifluperidol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 74,
   "INTRAMUSCULAR": 30
  },
  "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. Haloperidol is not approved for the treatment of patient...",
  "indications_and_usage": "INDICATIONS AND USAGE Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette\u2019s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
  "contraindications": "CONTRAINDICATIONS Haloperidol tablets, USP are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson\u2019s disease.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 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. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, ...",
  "adverse_reactions": "ADVERSE REACTIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS ). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs. CNS Effects Extrapyramidal Symptoms (EPS) EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). Whi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Haloperidol",
  "manufacturer": "REMEDYREPACK INC.",
  "application_number": "ANDA071173",
  "pharm_class_epc": [
   "Typical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260731",
  "set_id": "051f3c99-7d16-4185-a857-c90440e1b1c5",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 30261,
  "serious": 26617,
  "death": 4267,
  "hospitalization": 14557,
  "primary_suspect": 29847,
  "top_reactions": [
   [
    "Drug Ineffective",
    2611
   ],
   [
    "Off Label Use",
    2099
   ],
   [
    "Drug Interaction",
    1853
   ],
   [
    "Neuroleptic Malignant Syndrome",
    1571
   ],
   [
    "Toxicity To Various Agents",
    1233
   ],
   [
    "Somnolence",
    1158
   ],
   [
    "Extrapyramidal Disorder",
    1072
   ],
   [
    "Tremor",
    944
   ],
   [
    "Agitation",
    935
   ],
   [
    "Condition Aggravated",
    922
   ],
   [
    "Weight Increased",
    916
   ],
   [
    "Confusional State",
    907
   ],
   [
    "Vomiting",
    866
   ],
   [
    "Pyrexia",
    856
   ],
   [
    "Nausea",
    853
   ]
  ],
  "by_year": {
   "2019": 2965,
   "2020": 2838,
   "2021": 2607,
   "2022": 2360,
   "2023": 2323,
   "2024": 2006,
   "2025": 1963,
   "2026": 811
  },
  "by_year_primary": {
   "2019": 2956,
   "2020": 2827,
   "2021": 2590,
   "2022": 2273,
   "2023": 2212,
   "2024": 1929,
   "2025": 1911,
   "2026": 774
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251010",
   "reason": "Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.",
   "firm": "Safecor Health, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250402",
   "reason": "Lack of assurance of sterility. Bacterial contamination detected in some media fill units",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250402",
   "reason": "Lack of assurance of sterility. Bacterial contamination detected in some media fill units",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250402",
   "reason": "Lack of assurance of sterility. Bacterial contamination detected in some media fill units",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250321",
   "reason": "Lack of Assurance of Sterility: Media fill with bacterial contamination",
   "firm": "Somerset Therapeutics Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250321",
   "reason": "Lack of Assurance of Sterility: Media fill with bacterial contamination",
   "firm": "Somerset Therapeutics Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20160407",
   "reason": "Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150218",
   "reason": "Lack of Assurance of Sterility; due to leaking vials",
   "firm": "Mylan Institutional LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150218",
   "reason": "Lack of Assurance of Sterility; due to leaking vials",
   "firm": "Mylan Institutional LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20140414",
   "reason": "Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.",
   "firm": "Fresenius Kabi USA LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 125,
  "nda": 6,
  "anda": 80,
  "first_approval": "19670412",
  "rems": false,
  "rems_last": "19740521",
  "labeling_supplements": 85,
  "labeling_recent": 2,
  "sponsors": [
   "ABRAXIS PHARM",
   "ACTAVIS GROUP",
   "ACTAVIS MID ATLANTIC",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALPHARMA",
   "APPCO"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/12/1967"
 },
 "trials": {
  "total": 198,
  "completed": 129,
  "terminated": 37,
  "with_results": 44,
  "industry": 51,
  "phase3": 51,
  "results_share": 0.34108527131782945,
  "terminated_share": 0.18686868686868688
 },
 "pubmed": {
  "rct": 630,
  "meta": 59,
  "recent_rct": 22,
  "cochrane": [
   {
    "pmid": "38958149",
    "title": "Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders",
    "year": "2024"
   },
   {
    "pmid": "31006114",
    "title": "Haloperidol discontinuation for people with schizophrenia",
    "year": "2019"
   },
   {
    "pmid": "28758203",
    "title": "Haloperidol for psychosis-induced aggression or agitation (rapid tranquillisation)",
    "year": "2017"
   },
   {
    "pmid": "27889922",
    "title": "Haloperidol for long-term aggression in psychosis",
    "year": "2016"
   },
   {
    "pmid": "27885664",
    "title": "Haloperidol plus promethazine for psychosis-induced aggression",
    "year": "2016"
   },
   {
    "pmid": "26524474",
    "title": "Haloperidol for the treatment of nausea and vomiting in palliative care patients",
    "year": "2015"
   },
   {
    "pmid": "25592299",
    "title": "Haloperidol versus first-generation antipsychotics for the treatment of schizophrenia and other psychotic disorders",
    "year": "2015"
   },
   {
    "pmid": "25007358",
    "title": "Haloperidol versus low-potency first-generation antipsychotic drugs for schizophrenia",
    "year": "2014"
   },
   {
    "pmid": "24242360",
    "title": "Haloperidol versus placebo for schizophrenia",
    "year": "2013"
   },
   {
    "pmid": "23983042",
    "title": "Haloperidol dose for the acute phase of schizophrenia",
    "year": "2013"
   },
   {
    "pmid": "23152276",
    "title": "Haloperidol for psychosis-induced aggression or agitation (rapid tranquillisation)",
    "year": "2012"
   },
   {
    "pmid": "19588366",
    "title": "Haloperidol plus promethazine for psychosis-induced aggression",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "haloperidol",
   "Haldol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1329281,
  "beneficiaries": 209284,
  "spend": 44500327.59,
  "by_brand": [
   {
    "brand": "Haloperidol",
    "claims": 939570,
    "per_claim": 29.162690486,
    "is_generic": true
   },
   {
    "brand": "Haloperidol Decanoate",
    "claims": 312420,
    "per_claim": 48.632833749,
    "is_generic": true
   },
   {
    "brand": "Haloperidol Lactate",
    "claims": 72963,
    "per_claim": 22.860248482,
    "is_generic": true
   },
   {
    "brand": "Haloperidol Decanoate 100",
    "claims": 4291,
    "per_claim": 53.627154509,
    "is_generic": false
   },
   {
    "brand": "Haldol Decanoate 100",
    "claims": 24,
    "per_claim": 173.22208333,
    "is_generic": false
   },
   {
    "brand": "Haldol Decanoate 50",
    "claims": 13,
    "per_claim": 295.75461538,
    "is_generic": false
   }
  ],
  "per_claim": 33.476990636291355
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "haloperidol",
  "matched": "haloperidol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4614,
  "fills": 1329281,
  "per_million": 3471.0493868489807,
  "ratio": 1.2535617094883824,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 63,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "3,471 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 65,
   "letter": "C",
   "why": [
    "630 randomized trials and 59 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 34% 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": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 1 Class III across 80 generic makers (-6)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "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 (80 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "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 drug interaction, neuroleptic malignant syndrome. 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 benperidol, bromperidol, droperidol? 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.)"
 ]
}