{
 "query": "terazosin",
 "ingredient": "terazosin",
 "slug": "terazosin",
 "rxcui": "37798",
 "brands": [
  "Tezruly"
 ],
 "names": [
  "terazosin",
  "terazosin hydrochloride",
  "terazosin hydrochloride anhydrous"
 ],
 "classes": [
  {
   "id": "G04CA",
   "name": "Alpha-adrenoreceptor antagonists"
  }
 ],
 "alternatives": [
  "alfuzosin",
  "silodosin",
  "tamsulosin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 46
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
  "contraindications": "CONTRAINDICATIONS Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Syncope and \u201cFirst-dose\u201d Effect Terazosin capsules, like other alpha-adrenergic blocking agents, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy. A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-adrenergic blocking agents in association with rapid dosage increases or the introduction of another antihypertensive drug. Syncope is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe supraventricular tachycardia with heart rates of 120 to 160 beats per minute. Additionally, the possibility of the contribution of hemodilution to the symptoms of postural hypotension should be considered. To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of terazosin capsules, given at bedtime. The 2 mg, 5 mg and 10 mg capsules are not indicated as initial therapy. Dosage should then be increased slowly, according to recommendations in the...",
  "adverse_reactions": "ADVERSE REACTIONS Benign Prostatic Hyperplasia The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1%, and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p \u2264 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS ) adjusted for the length of drug treatment has shown that the risk of the events is g...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients (see Patient Package Insert) Patients should be made aware of the possibility of syncopal and orthostatic symptoms, especially at the initiation of therapy, and to avoid driving or hazardous tasks for 12 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. They should be cautioned to avoid situations where injury could result should syncope occur during initiation of terazosin therapy. They should also be advised of the need to sit or lie down when symptoms of lowered blood pressure occur, although these symptoms are not always orthostatic, and to be careful when rising from a sitting or lying position. If dizziness, lightheadedness, or palpitations are bothersome they should be reported to the physician, so that dose adjustment can be considered. Patients should also be told that drowsiness or somnolence can occur with terazosin, requiring caution in people who must drive or operate heavy machinery. Patients should be advised about the possibility of priapism as a result of treatment with terazosin capsules and other similar medications. Patients should know that this reaction to terazosin capsul...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Terazosin",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA075317",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230720",
  "set_id": "0574d9ae-04da-4cb2-b124-9d920012c411",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 5347,
  "serious": 3845,
  "death": 630,
  "hospitalization": 1991,
  "primary_suspect": 5321,
  "top_reactions": [
   [
    "Fatigue",
    380
   ],
   [
    "Dyspnoea",
    339
   ],
   [
    "Acute Kidney Injury",
    329
   ],
   [
    "Death",
    310
   ],
   [
    "Chronic Kidney Disease",
    295
   ],
   [
    "Off Label Use",
    295
   ],
   [
    "Diarrhoea",
    292
   ],
   [
    "Drug Ineffective",
    292
   ],
   [
    "Renal Failure",
    246
   ],
   [
    "Pain",
    240
   ],
   [
    "Asthenia",
    238
   ],
   [
    "Dizziness",
    236
   ],
   [
    "Nausea",
    207
   ],
   [
    "Headache",
    189
   ],
   [
    "Fall",
    186
   ]
  ],
  "by_year": {
   "2019": 618,
   "2020": 755,
   "2021": 677,
   "2022": 487,
   "2023": 435,
   "2024": 389,
   "2025": 371,
   "2026": 169
  },
  "by_year_primary": {
   "2019": 616,
   "2020": 754,
   "2021": 670,
   "2022": 484,
   "2023": 434,
   "2024": 383,
   "2025": 366,
   "2026": 168
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 16,
  "nda": 3,
  "anda": 13,
  "first_approval": "19870807",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "ABBOTT",
   "AJANTA PHARMA LTD",
   "BIONPHARMA",
   "CHARTWELL RX",
   "HERITAGE PHARMA AVET",
   "HIKMA",
   "IVAX SUB TEVA PHARMS",
   "JUBILANT CADISTA"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/07/1987"
 },
 "trials": {
  "total": 41,
  "completed": 21,
  "terminated": 4,
  "with_results": 9,
  "industry": 9,
  "phase3": 7,
  "results_share": 0.42857142857142855,
  "terminated_share": 0.0975609756097561
 },
 "pubmed": {
  "rct": 84,
  "meta": 6,
  "recent_rct": 4,
  "cochrane": [
   {
    "pmid": "21901686",
    "title": "WITHDRAWN: Terazosin for benign prostatic hyperplasia",
    "year": "2011"
   },
   {
    "pmid": "12519611",
    "title": "Terazosin for benign prostatic hyperplasia",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "terazosin",
   "Tezruly"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1320017,
  "beneficiaries": 325409,
  "spend": 28837243.84,
  "by_brand": [
   {
    "brand": "Terazosin HCl",
    "claims": 1320017,
    "per_claim": 21.846115497,
    "is_generic": true
   }
  ],
  "per_claim": 21.84611549699739
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 917,
  "fills": 1320017,
  "per_million": 694.6880229572802,
  "ratio": 0.25088502310535443,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "695 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 49,
   "letter": "F",
   "why": [
    "84 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "Only 43% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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 (13 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 87,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, dyspnoea, acute kidney injury, death. 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 alfuzosin, silodosin, tamsulosin? 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.)"
 ]
}