{
 "query": "buspirone",
 "ingredient": "buspirone",
 "slug": "buspirone",
 "rxcui": "1827",
 "brands": [
  "Bucapsol",
  "Buspar"
 ],
 "names": [
  "buspirone",
  "buspirone hydrochloride"
 ],
 "classes": [
  {
   "id": "N05BE",
   "name": "Azaspirodecanedione derivatives"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 166
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association\u2019s Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle ...",
  "contraindications": "CONTRAINDICATIONS Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride. The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated. Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS , DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS )",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride tablets have been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures,...",
  "adverse_reactions": "ADVERSE REACTIONS ( See also PRECAUTIONS ) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Associated with Discontinuation of Treatment One guide to the relative clinical importance of adverse events associated with buspirone hydrochloride tablets is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone hydrochloride tablets premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized ...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Class Buspirone hydrochloride is not a controlled substance. Physical and Psychological Dependence In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between buspirone hydrochloride tablets and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse. Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. Although there is no direct evidence that buspirone hydrochloride tablets causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Con...",
  "controlled_substance": "Controlled Substance Class Buspirone hydrochloride is not a controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients To assure safe and effective use of buspirone hydrochloride tablets, the following information and instructions should be given to patients: Do not take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. Do not take an MAOI within 2 weeks of stopping buspirone unless directed to do so by your physician Do not start buspirone if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with buspirone hydrochloride tablets. Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking buspirone hydrochloride tablets. Inform your physician if you are breast-feeding an infant. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery. You should take buspirone hydrochloride tablets consistently, either always with or always without food. Dur...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Buspirone Hydrochloride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA202557",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20181018",
  "set_id": "8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 99",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 33976,
  "serious": 19131,
  "death": 2574,
  "hospitalization": 8522,
  "primary_suspect": 33836,
  "top_reactions": [
   [
    "Nausea",
    2372
   ],
   [
    "Fatigue",
    2337
   ],
   [
    "Drug Ineffective",
    2311
   ],
   [
    "Anxiety",
    2000
   ],
   [
    "Headache",
    1846
   ],
   [
    "Diarrhoea",
    1620
   ],
   [
    "Pain",
    1616
   ],
   [
    "Off Label Use",
    1596
   ],
   [
    "Dizziness",
    1533
   ],
   [
    "Dyspnoea",
    1415
   ],
   [
    "Depression",
    1404
   ],
   [
    "Fall",
    1240
   ],
   [
    "Vomiting",
    1145
   ],
   [
    "Insomnia",
    1095
   ],
   [
    "Product Dose Omission Issue",
    1085
   ]
  ],
  "by_year": {
   "2019": 3040,
   "2020": 3107,
   "2021": 2682,
   "2022": 2886,
   "2023": 2922,
   "2024": 3162,
   "2025": 3606,
   "2026": 1804
  },
  "by_year_primary": {
   "2019": 3038,
   "2020": 3100,
   "2021": 2680,
   "2022": 2859,
   "2023": 2887,
   "2024": 3133,
   "2025": 3575,
   "2026": 1797
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260413",
   "reason": "Subpotent drug",
   "firm": "Unichem Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20231027",
   "reason": "Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots",
   "firm": "NCS Healthcare of Kentucky Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20231027",
   "reason": "Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots",
   "firm": "NCS Healthcare of Kentucky Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230316",
   "reason": "CGMP Deviations",
   "firm": "Northwind Pharmaceuticals 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"
  },
  {
   "class": "Class II",
   "date": "20210505",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Oxford Pharmaceuticals, LLC",
   "status": "Completed"
  }
 ],
 "recall_total": 10,
 "drugsfda": {
  "applications": 24,
  "nda": 2,
  "anda": 22,
  "first_approval": "19860929",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ADAPTIS",
   "AIPING PHARM INC",
   "AMNEAL PHARMS CO",
   "AUROBINDO PHARMA LTD",
   "BRISTOL MYERS SQUIBB",
   "EGIS",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/29/1986"
 },
 "trials": {
  "total": 72,
  "completed": 48,
  "terminated": 11,
  "with_results": 22,
  "industry": 12,
  "phase3": 10,
  "results_share": 0.4583333333333333,
  "terminated_share": 0.1527777777777778
 },
 "pubmed": {
  "rct": 191,
  "meta": 4,
  "recent_rct": 9,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "buspirone",
   "Bucapsol",
   "Buspar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7847445,
  "beneficiaries": 1554487,
  "spend": 111220887.92,
  "by_brand": [
   {
    "brand": "Buspirone HCl",
    "claims": 7847445,
    "per_claim": 14.172878933,
    "is_generic": true
   }
  ],
  "per_claim": 14.172878933206922
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8505,
  "fills": 7847445,
  "per_million": 1083.7922406592209,
  "ratio": 0.39140913957561263,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,084 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 48,
   "letter": "F",
   "why": [
    "191 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 3 Class III across 22 generic makers (-7)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (22 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, fatigue, anxiety. How would we recognize and handle those?",
  "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.)"
 ]
}