{
 "query": "aripiprazole",
 "ingredient": "aripiprazole",
 "slug": "aripiprazole",
 "rxcui": "89013",
 "brands": [
  "Abilify",
  "Opipza"
 ],
 "names": [
  "aripiprazole"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 116,
   "INTRAMUSCULAR": 1
  },
  "boxed_warning": "WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . 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 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (5.3) ] . 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 (5.3) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIO...",
  "indications_and_usage": "(aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )",
  "contraindications": "is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2) ] . Known hypersensitivity to ABILIFY ( 4 )",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.1 , 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain ( 5.6 ) Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes ( 5.6 ) Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ( 5.6 ) Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation ( 5.7 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.8 ) Leukopenia,...",
  "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 Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia [see Warnings and Pre...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance ABILIFY is not a controlled substance. 9.2 Abuse ABILIFY has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of ABILIFY misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). 9.3 Dependence In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. 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.",
  "controlled_substance": "9.1 Controlled Substance ABILIFY is not a controlled substance.",
  "recent_major_changes": "Indications and Usage ( 1 ) 1/2025 Dosage and Administration Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection) (2.6) Removed 1/2025 Dosing of Oral Solution (2.8) Removed 1/2025 Dosing of Orally Disintegrating Tablet (2.9) Removed 1/2025 Warnings and Precautions Orthostatic Hypotension ( 5.8 ) 1/2025 Seizures/Convulsions ( 5.11 ) 1/2025 Potential for Cognitive and Motor Impairment ( 5.12 ) 1/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide) . Clinical Worsening of Depression and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.3) ] . Prescribers or other health professionals should inform patients, their famil...",
  "spl_medguide": "MEDICATION GUIDE ABILIFY \u00ae (a BIL \u012d f\u012b) (aripiprazole) Tablets This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 1/2025 What is the most important information I should know about ABILIFY? (For other side effects, also see \" What are the possible side effects of ABILIFY? \") Serious side effects may happen when you take ABILIFY, including: Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. T...",
  "clinical_studies": "Efficacy of ABILIFY was established in the following adequate and well-controlled trials: Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13 to 17 years) with schizophrenia [see Clinical Studies (14.1) ] Four short-term monotherapy trials and one 6-week adjunctive trial in adult patients and one short-term monotherapy trial in pediatric patients (ages 10 to 17 years) with manic or mixed episodes [see Clinical Studies (14.2) ] One maintenance monotherapy trial and one maintenance adjunctive trial in adult patients with bipolar I disorder [see Clinical Studies (14.2) ] Two short-term trials in adult patients with MDD who had an inadequate response to antidepressant therapy during the current episode [see Clinical Studies (14.3) ] Two short-term trials in pediatric patients (ages 6 to 17 years) for the treatment of irritability associated with autistic disorder [see Clinical Studies (14.4) ] Two short-term trials in pediatric patients (ages 6 to 18 years) with Tourette's Disorder [see Clinical Studies (14.5) ] 14.1 Schizophrenia Adults The efficacy of ABILIFY in the treatment of schizophrenia was evaluated in five short-...",
  "brand_name": "ABILIFY",
  "manufacturer": "Otsuka America Pharmaceutical, Inc.",
  "application_number": "NDA021436",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250129",
  "set_id": "c040bd1d-45b7-49f2-93ea-aed7220b30ac",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
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  "serious": 68050,
  "death": 5363,
  "hospitalization": 30300,
  "primary_suspect": 95004,
  "top_reactions": [
   [
    "Drug Ineffective",
    7538
   ],
   [
    "Off Label Use",
    7452
   ],
   [
    "Weight Increased",
    5780
   ],
   [
    "Product Use In Unapproved Indication",
    5393
   ],
   [
    "Anxiety",
    4377
   ],
   [
    "Fatigue",
    3636
   ],
   [
    "Suicidal Ideation",
    3501
   ],
   [
    "Nausea",
    3274
   ],
   [
    "Suicide Attempt",
    3248
   ],
   [
    "Depression",
    3235
   ],
   [
    "Drug Interaction",
    3180
   ],
   [
    "Condition Aggravated",
    3062
   ],
   [
    "Insomnia",
    2970
   ],
   [
    "Somnolence",
    2945
   ],
   [
    "Tremor",
    2720
   ]
  ],
  "by_year": {
   "2019": 6944,
   "2020": 7018,
   "2021": 8141,
   "2022": 6228,
   "2023": 6583,
   "2024": 6724,
   "2025": 5887,
   "2026": 3308
  },
  "by_year_primary": {
   "2019": 6935,
   "2020": 7001,
   "2021": 8085,
   "2022": 6074,
   "2023": 6369,
   "2024": 6579,
   "2025": 5761,
   "2026": 3228
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260527",
   "reason": "Product Mix-Up:  A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.",
   "firm": "Ajanta Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250828",
   "reason": "Superpotent drug",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240409",
   "reason": "Cross Contamination with Other Products",
   "firm": "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240409",
   "reason": "Cross Contamination with Other Products",
   "firm": "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240409",
   "reason": "Cross Contamination with Other Products",
   "firm": "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240409",
   "reason": "Cross Contamination with Other Products",
   "firm": "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230317",
   "reason": "Out of specification (OOS) for Spectroscopic Identification test by IR.",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 18,
 "drugsfda": {
  "applications": 51,
  "nda": 9,
  "anda": 37,
  "first_approval": "20021115",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 94,
  "labeling_recent": 11,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/15/2002"
 },
 "trials": {
  "total": 467,
  "completed": 314,
  "terminated": 63,
  "with_results": 167,
  "industry": 274,
  "phase3": 122,
  "results_share": 0.5318471337579618,
  "terminated_share": 0.1349036402569593
 },
 "pubmed": {
  "rct": 314,
  "meta": 92,
  "recent_rct": 40,
  "cochrane": [
   {
    "pmid": "29308601",
    "title": "Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation)",
    "year": "2018"
   },
   {
    "pmid": "27344135",
    "title": "Aripiprazole for autism spectrum disorders (ASD)",
    "year": "2016"
   },
   {
    "pmid": "24385408",
    "title": "Aripiprazole versus other atypical antipsychotics for schizophrenia",
    "year": "2014"
   },
   {
    "pmid": "24346956",
    "title": "Aripiprazole alone or in combination for acute mania",
    "year": "2013"
   },
   {
    "pmid": "23450570",
    "title": "Aripiprazole versus other atypical antipsychotics for schizophrenia",
    "year": "2013"
   },
   {
    "pmid": "22592735",
    "title": "Aripiprazole for autism spectrum disorders (ASD)",
    "year": "2012"
   },
   {
    "pmid": "21833956",
    "title": "Aripiprazole versus placebo for schizophrenia",
    "year": "2011"
   },
   {
    "pmid": "19821375",
    "title": "Aripiprazole versus other atypical antipsychotics for schizophrenia",
    "year": "2009"
   },
   {
    "pmid": "18646161",
    "title": "Aripiprazole versus typical antipsychotic drugs for schizophrenia",
    "year": "2008"
   },
   {
    "pmid": "18254107",
    "title": "Aripiprazole versus typicals for schizophrenia",
    "year": "2008"
   },
   {
    "pmid": "16625607",
    "title": "Aripiprazole for schizophrenia",
    "year": "2006"
   },
   {
    "pmid": "15106256",
    "title": "Aripiprazole for schizophrenia",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 876.67,
  "records": 31,
  "by_name": [
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    876.67
   ]
  ],
  "names_checked": [
   "aripiprazole",
   "Abilify",
   "Opipza"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4111568,
  "beneficiaries": 684239,
  "spend": 967982256.16,
  "by_brand": [
   {
    "brand": "Aripiprazole",
    "claims": 3844727,
    "per_claim": 63.799097801,
    "is_generic": true
   },
   {
    "brand": "Abilify Maintena",
    "claims": 235220,
    "per_claim": 2738.8547646,
    "is_generic": false
   },
   {
    "brand": "Aripiprazole ODT",
    "claims": 12808,
    "per_claim": 636.71782245,
    "is_generic": false
   },
   {
    "brand": "Abilify Asimtufii",
    "claims": 11621,
    "per_claim": 5433.0980595,
    "is_generic": false
   },
   {
    "brand": "Abilify",
    "claims": 7139,
    "per_claim": 991.07546295,
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   },
   {
    "brand": "Abilify Mycite",
    "claims": 53,
    "per_claim": 1704.1958491,
    "is_generic": false
   }
  ],
  "per_claim": 235.42897895887893
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160503",
   "title": "FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm498662.htm",
   "kind": "drug",
   "matched": "abilify"
  }
 ],
 "settlements": [
  {
   "year": 2007,
   "company": "Bristol-Myers Squibb",
   "amount_usd": 515000000.0,
   "amount_text": "$515 million",
   "violations": "Off-label promotion, kickbacks, Medicare fraud",
   "products": "Abilify, Serzone",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2007/September/07_civ_782.html"
   ],
   "matched": "abilify"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "aripiprazole",
  "matched": "aripiprazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15568,
  "fills": 4111568,
  "per_million": 3786.3900098453923,
  "ratio": 1.3674462689913995,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 54,
   "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 2016 (-8)",
    "3,786 FDA reports naming it as the suspect drug per million Medicare fills, 1.4x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 78,
   "letter": "B",
   "why": [
    "314 randomized trials and 92 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",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 80,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 13 Class II, 4 Class III across 37 generic makers (-7)",
    "11 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": 85,
   "letter": "B",
   "why": [
    "Maker paid $515 million in 2007 to settle federal allegations naming this drug (Off-label promotion, kickbacks, Medicare fraud) (-15)",
    "Pharma paid doctors $877 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (37 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify). Does that risk apply to me?",
  "The maker paid $515 million in 2007 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 weight increased, product use in unapproved indication. 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.)"
 ]
}