{
 "query": "paliperidone",
 "ingredient": "paliperidone",
 "slug": "paliperidone",
 "rxcui": "679314",
 "brands": [
  "Invega",
  "Erzofri"
 ],
 "names": [
  "paliperidone",
  "paliperidone palmitate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 25,
   "INTRAMUSCULAR": 4
  },
  "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. INVEGA 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. INVEGA is not approved for use in patients with dementia-related psychosis. ( 5.1 )",
  "indications_and_usage": "is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12\u201317): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ] . The efficacy of INVEGA in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults. 1.2 Schizoaffective Disorder INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2) ] . The efficacy of INVEGA in schizoaffective disorder was established in two 6-week trials in adults.",
  "contraindications": "is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. 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 paliperidone, risperidone, or to any excipients in INVEGA. ( 4 )",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack, including fatalities) has been seen in elderly patients with dementia- related psychoses treated with atypical antipsychotics. ( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring. ( 5.3 ) QT Prolongation: Increase in QT interval, avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval. ( 5.4 ) Tardive Dyskinesia: Discontinue drug if clinically appropriate. ( 5.5 ) 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. ( 5.6 ) 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. ( 5.6 ) Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. ( 5.6 ) Weight Gai...",
  "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) ] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] QT prolongation [see Warnings and Precautions (5.4) ] Tardive dyskinesia [see Warnings and Precautions (5.5) ] Metabolic changes [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Potential for gastrointestinal obstruction [see Warnings and Precautions (5.8) ] Orthostatic hypotension and syncope [see Warnings and Precautions (5.9) ] Falls [see Warnings and Precautions (5.10) ] Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions (5.11) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Dysphagia [see Warnings and Precautions (5.14) ] Priapism [see Warnings and Precautions (5.15) ] Disruption of body temperat...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance INVEGA (paliperidone) is not a controlled substance. 9.2 Abuse Paliperidone has not been systematically studied in animals or humans for its potential for abuse. It is not possible to predict 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 INVEGA misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). 9.3 Dependence Paliperidone has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.",
  "controlled_substance": "9.1 Controlled Substance INVEGA (paliperidone) is not a controlled substance.",
  "recent_major_changes": "Dosage and Administration ( 2.5 ) 1/2025 Warnings and Precautions ( 5.7 ) 1/2025",
  "information_for_patients": "Physicians are advised to discuss the following issues with patients for whom they prescribe INVEGA. 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 their 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 (5.5) ]. Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.6) ]. Orthostatic Hyp...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Schizophrenia Adults The acute efficacy of INVEGA (3 mg to 15 mg once daily) was established in three placebo-controlled and active-controlled (olanzapine), 6-week, fixed-dose trials in non-elderly adult subjects (mean age of 37) who met DSM-IV criteria for schizophrenia. Studies were carried out in North America, Eastern Europe, Western Europe, and Asia. The doses studied among these three trials included 3 mg/day, 6 mg/day, 9 mg/day, 12 mg/day, and 15 mg/day. Dosing was in the morning without regard to meals. Efficacy was evaluated using the Positive and Negative Syndrome Scale (PANSS), a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. Efficacy was also evaluated using the Personal and Social Performance (PSP) scale. The PSP is a validated clinician-rated scale that measures personal and social functioning in the domains of socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. In all 3 studies (n=1665), INVEGA was superior to placebo on the PANSS at all d...",
  "brand_name": "INVEGA",
  "manufacturer": "Janssen Pharmaceuticals, Inc.",
  "application_number": "NDA021999",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250131",
  "set_id": "7b8e5b26-b9e4-4704-921b-3c3c0d159916",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 46498,
  "serious": 22516,
  "death": 2084,
  "hospitalization": 10424,
  "primary_suspect": 46360,
  "top_reactions": [
   [
    "Off Label Use",
    4696
   ],
   [
    "Injury",
    4355
   ],
   [
    "Gynaecomastia",
    4170
   ],
   [
    "Drug Ineffective",
    3207
   ],
   [
    "Weight Increased",
    2393
   ],
   [
    "Hospitalisation",
    2219
   ],
   [
    "Abnormal Weight Gain",
    1819
   ],
   [
    "Schizophrenia",
    1551
   ],
   [
    "Product Dose Omission Issue",
    1525
   ],
   [
    "Hyperprolactinaemia",
    1477
   ],
   [
    "Treatment Noncompliance",
    1405
   ],
   [
    "Galactorrhoea",
    1311
   ],
   [
    "Condition Aggravated",
    1304
   ],
   [
    "Product Use In Unapproved Indication",
    1260
   ],
   [
    "Psychotic Disorder",
    1090
   ]
  ],
  "by_year": {
   "2019": 3313,
   "2020": 2948,
   "2021": 2875,
   "2022": 3739,
   "2023": 3254,
   "2024": 3018,
   "2025": 3109,
   "2026": 1545
  },
  "by_year_primary": {
   "2019": 3313,
   "2020": 2945,
   "2021": 2866,
   "2022": 3711,
   "2023": 3233,
   "2024": 2989,
   "2025": 3083,
   "2026": 1524
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220228",
   "reason": "Failed Dissolution Specifications",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 25,
  "nda": 5,
  "anda": 15,
  "first_approval": "20061219",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 46,
  "labeling_recent": 14,
  "sponsors": [
   "ACCORD HLTHCARE INC",
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL PHARMS",
   "APOTEX",
   "ASCENT PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/19/2006"
 },
 "trials": {
  "total": 216,
  "completed": 179,
  "terminated": 19,
  "with_results": 67,
  "industry": 167,
  "phase3": 60,
  "results_share": 0.3743016759776536,
  "terminated_share": 0.08796296296296297
 },
 "pubmed": {
  "rct": 125,
  "meta": 26,
  "recent_rct": 27,
  "cochrane": [
   {
    "pmid": "22696377",
    "title": "Paliperidone palmitate for schizophrenia",
    "year": "2012"
   },
   {
    "pmid": "18425951",
    "title": "Paliperidone for schizophrenia",
    "year": "2008"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 100344.09,
  "records": 1718,
  "by_name": [
   [
    "Invega",
    100344.09
   ]
  ],
  "names_checked": [
   "paliperidone",
   "Invega",
   "Erzofri"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1091524,
  "beneficiaries": 147657,
  "spend": 2617986357.9100003,
  "by_brand": [
   {
    "brand": "Invega Sustenna",
    "claims": 624867,
    "per_claim": 3005.6889824,
    "is_generic": false
   },
   {
    "brand": "Paliperidone ER",
    "claims": 392711,
    "per_claim": 199.2602595,
    "is_generic": false
   },
   {
    "brand": "Invega Trinza",
    "claims": 63911,
    "per_claim": 8602.6125944,
    "is_generic": false
   },
   {
    "brand": "Invega Hafyera",
    "claims": 5856,
    "per_claim": 18686.59153,
    "is_generic": false
   },
   {
    "brand": "Invega",
    "claims": 4179,
    "per_claim": 561.98880593,
    "is_generic": false
   }
  ],
  "per_claim": 2398.468891119206
 },
 "mdl": [],
 "dsc": [],
 "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": "invega"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "paliperidone",
  "matched": "paliperidone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7596,
  "fills": 1091524,
  "per_million": 6959.077400038845,
  "ratio": 2.5132552118406988,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 57,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "6,959 FDA reports naming it as the suspect drug per million Medicare fills, 2.5x the median drug on this site (-8)",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "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": [
    "125 randomized trials and 26 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 37% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 15 generic makers (-1)",
    "14 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": 50,
   "letter": "D",
   "why": [
    "Maker paid $2.2 billion in 2013 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-35)",
    "Pharma paid doctors $100,344 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (15 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 62,
 "grade": "D",
 "questions": [
  "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 injury, gynaecomastia. 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?",
  "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.)"
 ]
}