{
 "query": "doxazosin",
 "ingredient": "doxazosin",
 "slug": "doxazosin",
 "rxcui": "49276",
 "brands": [
  "Cardura"
 ],
 "names": [
  "doxazosin",
  "doxazosin mesylate"
 ],
 "classes": [
  {
   "id": "C02CA",
   "name": "Alpha-adrenoreceptor antagonists"
  }
 ],
 "alternatives": [
  "indoramin",
  "prazosin",
  "urapidil"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 64
  },
  "boxed_warning": "",
  "indications_and_usage": "Doxazosin is an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablet is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pre...",
  "contraindications": "The use of Doxazosin tablet is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in Doxazosin. ( 4 )",
  "warnings_and_cautions": "Postural hypotension with or without syncope may occur. ( 5.1 ) Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. ( 5.2 ) Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. ( 5.3 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of Doxazosin. However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing. As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Advise patient how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. Concomitant administration of Doxazosin with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. 5.2 Cataract Surgery Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris th...",
  "warnings": "",
  "adverse_reactions": "The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC Professional Information Services at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Benign Prostatic Hyperplasia (BPH) The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of Doxazosin tablet in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with Doxazosin vs placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Doxazos...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Postural Hypotension Advise patients of the possibility of syncopal and orthostatic symptoms, especially at the initiation of therapy, and urged to avoid driving or hazardous tasks for 24 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. Advise patients to report symptoms to their healthcare provider. Priapism Advise patients of the possibility of priapism and to seek immediate medical attention if symptoms occur. This product's label may have been updated. For full prescribing information, please visit www.greenstonellc.com.",
  "spl_medguide": "",
  "clinical_studies": "14.1 Benign Prostatic Hyperplasia (BPH) The efficacy of Doxazosin tablet was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. Doxazosin tablet treatment was superior to placebo in improving patient symptoms and urinary flow rate. Significant relief with Doxazosin tablet was seen as early as one week into the treatment regimen, with Doxazosin tablet -treated patients (N=173) showing a significant (p<0.01) increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group (N=41). In long-term studies, improvement was maintained for up to 2 years of treatment. In 66\u201371% of patients, improvements above baseline were seen in both symptoms and maximum urinary flow rate. In three placebo-controlled studies of 14\u201316 weeks' duration, obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning) of BPH were evaluated at each visit by patient-assessed symptom questionnaires. The bothersomeness of symptoms was measured with a modified Boyarsky questionnaire. Symptom severity/frequency was...",
  "brand_name": "Doxazosin",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA019668",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220203",
  "set_id": "b364c7a8-72b5-4776-a500-400c37a72c9b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 21070,
  "serious": 17805,
  "death": 1866,
  "hospitalization": 9044,
  "primary_suspect": 20930,
  "top_reactions": [
   [
    "Dyspnoea",
    1171
   ],
   [
    "Fatigue",
    1067
   ],
   [
    "Diarrhoea",
    1032
   ],
   [
    "Dizziness",
    995
   ],
   [
    "Acute Kidney Injury",
    915
   ],
   [
    "Drug Ineffective",
    883
   ],
   [
    "Nausea",
    854
   ],
   [
    "Off Label Use",
    820
   ],
   [
    "Headache",
    774
   ],
   [
    "Hypotension",
    717
   ],
   [
    "Asthenia",
    702
   ],
   [
    "Hypertension",
    700
   ],
   [
    "Death",
    671
   ],
   [
    "Condition Aggravated",
    626
   ],
   [
    "Chronic Kidney Disease",
    617
   ]
  ],
  "by_year": {
   "2019": 2423,
   "2020": 2452,
   "2021": 2127,
   "2022": 1973,
   "2023": 1999,
   "2024": 1775,
   "2025": 2008,
   "2026": 896
  },
  "by_year_primary": {
   "2019": 2421,
   "2020": 2441,
   "2021": 2122,
   "2022": 1942,
   "2023": 1974,
   "2024": 1756,
   "2025": 1986,
   "2026": 875
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260121",
   "reason": "Tablets/Capsules Imprinted with Wrong ID",
   "firm": "Unichem Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241223",
   "reason": "Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.",
   "firm": "Viatris Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20241223",
   "reason": "Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.",
   "firm": "Viatris 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"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 21,
  "nda": 2,
  "anda": 19,
  "first_approval": "19901102",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 2,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA USA",
   "CHARTWELL RX",
   "GENPHARM",
   "HERITAGE PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/02/1990"
 },
 "trials": {
  "total": 73,
  "completed": 58,
  "terminated": 7,
  "with_results": 21,
  "industry": 17,
  "phase3": 6,
  "results_share": 0.3620689655172414,
  "terminated_share": 0.0958904109589041
 },
 "pubmed": {
  "rct": 193,
  "meta": 8,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "doxazosin",
   "Cardura"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2212882,
  "beneficiaries": 533558,
  "spend": 36957543.92,
  "by_brand": [
   {
    "brand": "Doxazosin Mesylate",
    "claims": 2210014,
    "per_claim": 16.177482405,
    "is_generic": true
   },
   {
    "brand": "Cardura XL",
    "claims": 2157,
    "per_claim": 380.78293,
    "is_generic": false
   },
   {
    "brand": "Cardura",
    "claims": 711,
    "per_claim": 539.70821378,
    "is_generic": false
   }
  ],
  "per_claim": 16.701091120086836
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4617,
  "fills": 2212882,
  "per_million": 2086.419429504149,
  "ratio": 0.753505702531449,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,086 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "193 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 36% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 1 Class III across 19 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 (19 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, diarrhoea, dizziness. How would we recognize and handle those?",
  "Why this one over indoramin, prazosin, urapidil? 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.)"
 ]
}