{
 "query": "risperidone",
 "ingredient": "risperidone",
 "slug": "risperidone",
 "rxcui": "35636",
 "brands": [
  "Uzedy",
  "Perseris",
  "Risperdal",
  "Rykindo"
 ],
 "names": [
  "risperidone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 61
  },
  "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. Risperidone is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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. Risperidone is not approved for use in patients with dementia-related psychosis. ( 5.1 )",
  "indications_and_usage": "Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . 1.2 Bipolar Mania Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2) ] . Adjunctive Therapy Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3) ] . 1.3 Irritability Associated with...",
  "contraindications": "Risperidone Tablets, Oral Solution, or Orally Disintegrating Tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the Risperidone Tablets, Oral Solution, or Orally Disintegrating Tablets formulations. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone Tablets, Oral Solution, or Orally Disintegrating Tablets. ( 4 )",
  "warnings_and_cautions": "Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone is not approved for use in patients with dementia-related psychosis. ( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of risperidone and close monitoring. ( 5.3 ) Tardive dyskinesia: Consider discontinuing risperidone if clinically indicated. ( 5.4 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk. 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. ( 5.5 ) Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. ( 5.5 ) Weight Gain: Significant weight gain has been reported. Monitor weight gain. ( 5.5 ) Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. ( 5.6 ) Orthostatic hypotension: For patients at risk, conside...",
  "warnings": "",
  "adverse_reactions": "The following 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) ] Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Tardive dyskinesia [see Warnings and Precautions (5.4 )] Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions (5.5) ] Hyperprolactinemia [see Warnings and Precautions (5.6) ] Orthostatic hypotension [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.9) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Dysphagia [see Warnings and Precautions (5.12) ] Priapism [see Warnings and Precautions (5.13) ] Disruption of body temperature regulation [see Warnings and Precautions (5.14) ] Patients with Phenylketonuria [see Warnings and...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Risperidone is not a controlled substance. 9.2 Abuse Risperidone has not been systematically studied in animals or humans for its potential for abuse. 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 risperidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). 9.3 Dependence Risperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.",
  "controlled_substance": "9.1 Controlled Substance Risperidone is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.6 ) 1/2025",
  "information_for_patients": "Advise patients using the oral solution to read the FDA-approved patient labeling (Instructions for Use). Physicians are advised to discuss the following issues with patients for whom they prescribe risperidone. 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 report to the emergency room if they experience signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status including delirium, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3) ] . 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 (5.4) ] . Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Schizophrenia Adults Short-Term Efficacy The efficacy of risperidone in the treatment of schizophrenia was established in four short-term (4- to 8-week) controlled trials of psychotic inpatients who met DSM-III-R criteria for schizophrenia. 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 patient. In addition, the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessing Negative Symptoms (SANS) were employed. The results of the trials follow: (1) In a 6-week, placebo-controlled trial (n=160) involving titra...",
  "brand_name": "Risperidone",
  "manufacturer": "Janssen Pharmaceuticals, Inc.",
  "application_number": "NDA020588",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260820",
  "set_id": "701e1cd8-2868-4d29-85a9-a2212c88165f",
  "has_boxed_warning": true,
  "boxed_labels": "61 of 61",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 102460,
  "serious": 61121,
  "death": 6246,
  "hospitalization": 28598,
  "primary_suspect": 101705,
  "top_reactions": [
   [
    "Gynaecomastia",
    24563
   ],
   [
    "Off Label Use",
    12140
   ],
   [
    "Abnormal Weight Gain",
    9450
   ],
   [
    "Weight Increased",
    7688
   ],
   [
    "Drug Ineffective",
    6648
   ],
   [
    "Product Use In Unapproved Indication",
    6054
   ],
   [
    "Emotional Disorder",
    5876
   ],
   [
    "Injury",
    4523
   ],
   [
    "Hyperprolactinaemia",
    4185
   ],
   [
    "Galactorrhoea",
    3553
   ],
   [
    "Drug Interaction",
    3405
   ],
   [
    "Emotional Distress",
    3395
   ],
   [
    "Somnolence",
    3325
   ],
   [
    "Obesity",
    3203
   ],
   [
    "Extrapyramidal Disorder",
    2856
   ]
  ],
  "by_year": {
   "2019": 8485,
   "2020": 6840,
   "2021": 5523,
   "2022": 5812,
   "2023": 5480,
   "2024": 6161,
   "2025": 5527,
   "2026": 2580
  },
  "by_year_primary": {
   "2019": 8472,
   "2020": 6822,
   "2021": 5463,
   "2022": 5660,
   "2023": 5284,
   "2024": 6051,
   "2025": 5393,
   "2026": 2527
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20130911",
   "reason": "Non-Sterility: Janssen  is recalling  one lot of Risperdal CONSTA (risperiDONE)   due to a sterility failure in a  stability sample",
   "firm": "Janssen Pharmaceuticals, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 57,
  "nda": 8,
  "anda": 48,
  "first_approval": "19931229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 128,
  "labeling_recent": 20,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "AJANTA PHARMA LTD",
   "AMNEAL",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL MOLECULAR"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1993"
 },
 "trials": {
  "total": 605,
  "completed": 437,
  "terminated": 77,
  "with_results": 136,
  "industry": 338,
  "phase3": 129,
  "results_share": 0.3112128146453089,
  "terminated_share": 0.12727272727272726
 },
 "pubmed": {
  "rct": 700,
  "meta": 77,
  "recent_rct": 42,
  "cochrane": [
   {
    "pmid": "29634083",
    "title": "Risperidone for psychosis-induced aggression or agitation (rapid tranquillisation)",
    "year": "2018"
   },
   {
    "pmid": "29355909",
    "title": "Risperidone versus other antipsychotics for people with severe mental illness and co-occurring substance misuse",
    "year": "2018"
   },
   {
    "pmid": "27977041",
    "title": "Risperidone versus placebo for schizophrenia",
    "year": "2016"
   },
   {
    "pmid": "27648956",
    "title": "WITHDRAWN: Risperidone versus other atypical antipsychotic medication for schizophrenia",
    "year": "2016"
   },
   {
    "pmid": "27078222",
    "title": "Risperidone (depot) for schizophrenia",
    "year": "2016"
   },
   {
    "pmid": "21249678",
    "title": "Risperidone versus other atypical antipsychotics for schizophrenia",
    "year": "2011"
   },
   {
    "pmid": "20091611",
    "title": "Risperidone versus placebo for schizophrenia",
    "year": "2010"
   },
   {
    "pmid": "19821422",
    "title": "Risperidone dose for schizophrenia",
    "year": "2009"
   },
   {
    "pmid": "19370667",
    "title": "Risperidone for attention-deficit hyperactivity disorder in people with intellectual disabilities",
    "year": "2009"
   },
   {
    "pmid": "17253538",
    "title": "Risperidone for autism spectrum disorder",
    "year": "2007"
   },
   {
    "pmid": "17054229",
    "title": "Risperidone in long-term treatment for bipolar disorder",
    "year": "2006"
   },
   {
    "pmid": "16625629",
    "title": "Risperidone versus olanzapine for schizophrenia",
    "year": "2006"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 5619954.87,
  "records": 51079,
  "by_name": [
   [
    "Uzedy",
    5373811.0
   ],
   [
    "Perseris",
    246143.87
   ]
  ],
  "names_checked": [
   "risperidone",
   "Uzedy",
   "Perseris",
   "Risperdal",
   "Rykindo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3811919,
  "beneficiaries": 495915,
  "spend": 178585524.10999998,
  "by_brand": [
   {
    "brand": "Risperidone",
    "claims": 3699848,
    "per_claim": 13.968228446,
    "is_generic": true
   },
   {
    "brand": "Risperidone ODT",
    "claims": 67508,
    "per_claim": 142.68478269,
    "is_generic": false
   },
   {
    "brand": "Uzedy",
    "claims": 20266,
    "per_claim": 3222.2652275,
    "is_generic": false
   },
   {
    "brand": "Perseris",
    "claims": 17530,
    "per_claim": 2756.9248072,
    "is_generic": false
   },
   {
    "brand": "Risperdal",
    "claims": 6767,
    "per_claim": 538.12897148,
    "is_generic": false
   }
  ],
  "per_claim": 46.84924420219841
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20110613",
   "title": "Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm258805.htm",
   "kind": "drug",
   "matched": "risperdal"
  }
 ],
 "settlements": [
  {
   "year": 2013,
   "company": "Johnson & Johnson",
   "amount_usd": 2200000000.0,
   "amount_text": "$2.2 billion",
   "violations": "Off-label promotion, kickbacks",
   "products": "Risperdal, Invega, Nesiritide",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations"
   ],
   "matched": "risperdal"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "risperidone",
  "matched": "risperidone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 13971,
  "fills": 3811919,
  "per_million": 3665.0831247988217,
  "ratio": 1.3236365592339319,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "3,665 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 73,
   "letter": "C",
   "why": [
    "700 randomized trials and 77 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 31% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "20 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": 35,
   "letter": "F",
   "why": [
    "Maker paid $2.2 billion in 2013 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-35)",
    "Pharma paid doctors $5,619,955 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (48 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 63,
 "grade": "C",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and\u2026). Does that risk apply to me?",
  "The maker paid $2.2 billion in 2013 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 gynaecomastia, abnormal weight gain, weight increased. 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.)"
 ]
}