{
 "query": "alfuzosin",
 "ingredient": "alfuzosin",
 "slug": "alfuzosin",
 "rxcui": "17300",
 "brands": [
  "UroXatral"
 ],
 "names": [
  "alfuzosin",
  "alfuzosin hydrochloride"
 ],
 "classes": [
  {
   "id": "G04CA",
   "name": "Alpha-adrenoreceptor antagonists"
  }
 ],
 "alternatives": [
  "silodosin",
  "tamsulosin",
  "terazosin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 16
  },
  "boxed_warning": "",
  "indications_and_usage": "Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population.",
  "contraindications": "Alfuzosin hydrochloride extended-release tablets are contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ]. in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride extended-release tablets [ see Adverse Reactions ( 6.2 ) ] Moderate or severe hepatic impairment ( 4 , 8.7 , 12.3 ) Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) ( 4 , 5.4 , 7.1 , 12.3 ) Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients ( 4 , 6.2 )",
  "warnings_and_cautions": "Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 ) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6) Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen ( 5.8 ) Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval ( 5.9 , 12.2 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. As with other alpha-adrenergic antagonist...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions in clinical studies (incidence \u22652% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800- 706-5575 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 clinical practice. The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received alfuzosin hydrochloride 10 mg extended-release tablets. In these trials, 4% of patients taking alfuzosin hydrochloride 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group. Table 1 summarizes adverse reactions that occurred in \u22652% of patients receiving alfuzosin hydrochloride extended-release tablets, and at...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling. 17.1 Hypotension/Syncope Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning alfuzosin hydrochloride extended-release tablets, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [ see Warnings and Precautions ( 5.1 ) ]. 17.2 Intraoperative Floppy Iris Syndrome Patients should be instructed to tell their ophthalmologist about their use of alfuzosin hydrochloride extended-release tablets before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking alfuzosin hydrochloride extended-release tablets [ see Warnings and Precautions ( 5.6 ) ]. 17.3 Priapism Patients should be advised about the possibility of priapism resulting from treatment with alfuzosin hydrochloride extended-release tablets and medications in the same class. Although this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction ...",
  "spl_medguide": "",
  "clinical_studies": "Three randomized placebo-controlled, double-blind, parallel-arm, 12-week trials were conducted with the 10 mg daily dose of alfuzosin. In these three trials, 1,608 patients [mean age 64.2 years, range 49-92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), Other (1.2%)] were randomized and 473 patients received alfuzosin hydrochloride extended-release tablets 10 mg daily. Table 4 provides the results of the three trials that evaluated the 10 mg dose. There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in trials 1 and 3. There was a statistically significant reduction from baselin...",
  "brand_name": "Alfuzosin Hydrochloride",
  "manufacturer": "Apotex Corp.",
  "application_number": "ANDA079013",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260903",
  "set_id": "26fcc267-c8d7-e059-1bcf-830dded43690",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 12023,
  "serious": 9840,
  "death": 1127,
  "hospitalization": 5544,
  "primary_suspect": 11887,
  "top_reactions": [
   [
    "Acute Kidney Injury",
    612
   ],
   [
    "Drug Ineffective",
    528
   ],
   [
    "Fatigue",
    525
   ],
   [
    "Off Label Use",
    482
   ],
   [
    "Fall",
    478
   ],
   [
    "Drug Interaction",
    473
   ],
   [
    "Diarrhoea",
    432
   ],
   [
    "Dizziness",
    419
   ],
   [
    "Dyspnoea",
    411
   ],
   [
    "Hypotension",
    393
   ],
   [
    "Asthenia",
    365
   ],
   [
    "Anaemia",
    329
   ],
   [
    "Death",
    320
   ],
   [
    "Confusional State",
    304
   ],
   [
    "Nausea",
    300
   ]
  ],
  "by_year": {
   "2019": 1162,
   "2020": 1299,
   "2021": 926,
   "2022": 877,
   "2023": 905,
   "2024": 1031,
   "2025": 999,
   "2026": 411
  },
  "by_year_primary": {
   "2019": 1160,
   "2020": 1296,
   "2021": 918,
   "2022": 863,
   "2023": 872,
   "2024": 1005,
   "2025": 969,
   "2026": 393
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20170105",
   "reason": "Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 10,
  "nda": 1,
  "anda": 9,
  "first_approval": "20030612",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 0,
  "sponsors": [
   "ADVANZ PHARMA",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX",
   "INVAGEN PHARMS",
   "PHARMOBEDIENT",
   "SUN PHARM",
   "TORRENT PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/12/2003"
 },
 "trials": {
  "total": 56,
  "completed": 40,
  "terminated": 8,
  "with_results": 11,
  "industry": 39,
  "phase3": 19,
  "results_share": 0.275,
  "terminated_share": 0.14285714285714285
 },
 "pubmed": {
  "rct": 68,
  "meta": 3,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "alfuzosin",
   "UroXatral"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1096845,
  "beneficiaries": 309887,
  "spend": 25778262.61,
  "by_brand": [
   {
    "brand": "Alfuzosin HCl ER",
    "claims": 1095800,
    "per_claim": 21.95488413,
    "is_generic": false
   },
   {
    "brand": "Uroxatral",
    "claims": 1045,
    "per_claim": 1646.0292632,
    "is_generic": false
   }
  ],
  "per_claim": 23.50219275285022
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2367,
  "fills": 1096845,
  "per_million": 2158.0077403826426,
  "ratio": 0.779359660618083,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,158 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)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 32,
   "letter": "F",
   "why": [
    "68 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 28% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)"
   ],
   "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 (9 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are acute kidney injury, fatigue. 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?",
  "Why this one over silodosin, tamsulosin, terazosin? 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.)"
 ]
}