{
 "query": "torsemide",
 "ingredient": "torsemide",
 "slug": "torsemide",
 "rxcui": "38413",
 "brands": [
  "Soaanz"
 ],
 "names": [
  "torsemide"
 ],
 "classes": [
  {
   "id": "C03CA",
   "name": "Sulfonamides, plain"
  }
 ],
 "alternatives": [
  "bumetanide",
  "furosemide",
  "piretanide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 33
  },
  "boxed_warning": "",
  "indications_and_usage": "Torsemide is a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) 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. ( 1.2 ) 1.1 Edema Torsemide tablets are indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. 1.2 Hypertension Torsemide tablets are 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with torsemide. 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 i...",
  "contraindications": "Torsemide is contraindicated in patients with known hypersensitivity to torsemide or to povidone. Torsemide is contraindicated in patients who are anuric. Torsemide is contraindicated in patients with hepatic coma. Hypersensitivity to torsemide or povidone, anuria, and hepatic coma. ( 4 )",
  "warnings_and_cautions": "Hypotension and worsening renal function: monitor volume status and renal function periodically ( 5.1 ) Electrolyte and metabolic abnormalities: monitor serum electrolytes and blood glucose periodically. ( 5.2 ) Ototoxicity ( 5.3 , 7.6 ) 5.1 Hypotension and Worsening Renal Function Excessive diuresis may cause potentially symptomatic dehydration, blood volume reduction and hypotension and worsening renal function, including acute renal failure particularly in salt-depleted patients or those taking renin-angiotensin aldosterone inhibitors. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 5.2 Electrolyte and Metabolic Abnormalities Torsemide can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, and hypochloremic alkalosis. Treatment with torsemide can cause an increase in blood glucose levels and hyperglycemia. Asymptomatic hyperuricemia can occur and gout may rarely be precipitated. Monitor serum electrolytes and blood glucose periodically. 5.3 Ototoxicity Tinnitus and hearing loss (usually reversible) have be...",
  "warnings": "",
  "adverse_reactions": "The following risks are discussed in more detail in others sections: Hypotension and Worsening Renal Function [see Warnings and Precautions (5.1) ] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] The most common adverse reaction is excessive urination (6.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) 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. In pre-approval studies, torsemide has been evaluated for safety in approximately 4,000 subjects; over 800 of these subjects received torsemide for at least 6 months, and over 380 were treated for more than 1 year. Among these subjects were 564 who received torsemide during United States-based trials in which 274 other subjects received placebo. Discontinuation of therapy due to adverse reactions occurred ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Symptomatic Hypotension: Advise patients receiving torsemide that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patients should be told that if syncope occurs, torsemide should be discontinued until the physician has been consulted. All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.1) ]. Non-Steroidal Anti-inflammatory Drugs (NSAID): Advise patients to discuss with their physician before taking NSAID medications concomitantly [see Drug Interactions (7.1) ]. Distributed by: Avet Pharmaceuticals, Inc. East Brunswick, NJ 08816 40308 Revised: 05/2023 logo",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Torsemide",
  "manufacturer": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
  "application_number": "ANDA076894",
  "pharm_class_epc": [
   "Loop Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230630",
  "set_id": "03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 47792,
  "serious": 41238,
  "death": 6445,
  "hospitalization": 29137,
  "primary_suspect": 47383,
  "top_reactions": [
   [
    "Dyspnoea",
    5247
   ],
   [
    "General Physical Health Deterioration",
    3747
   ],
   [
    "Fatigue",
    3098
   ],
   [
    "Dizziness",
    2961
   ],
   [
    "Acute Kidney Injury",
    2891
   ],
   [
    "Nausea",
    2880
   ],
   [
    "Diarrhoea",
    2735
   ],
   [
    "Fall",
    2618
   ],
   [
    "Anaemia",
    2530
   ],
   [
    "Oedema Peripheral",
    2370
   ],
   [
    "Cardiac Failure",
    2189
   ],
   [
    "Hypotension",
    2140
   ],
   [
    "Death",
    2113
   ],
   [
    "Asthenia",
    1953
   ],
   [
    "Pneumonia",
    1875
   ]
  ],
  "by_year": {
   "2019": 4873,
   "2020": 5640,
   "2021": 4842,
   "2022": 4381,
   "2023": 3086,
   "2024": 3637,
   "2025": 3716,
   "2026": 1663
  },
  "by_year_primary": {
   "2019": 4871,
   "2020": 5601,
   "2021": 4820,
   "2022": 4245,
   "2023": 3038,
   "2024": 3565,
   "2025": 3664,
   "2026": 1635
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 15,
  "nda": 3,
  "anda": 12,
  "first_approval": "19930823",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 0,
  "sponsors": [
   "AM REGENT",
   "AUROBINDO PHARMA",
   "HERITAGE",
   "HETERO LABS LTD III",
   "HIKMA",
   "MICRO LABS",
   "PHARMOBEDIENT",
   "PLIVA PHARM IND"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/23/1993"
 },
 "trials": {
  "total": 51,
  "completed": 31,
  "terminated": 10,
  "with_results": 8,
  "industry": 23,
  "phase3": 9,
  "results_share": 0.25806451612903225,
  "terminated_share": 0.19607843137254902
 },
 "pubmed": {
  "rct": 26,
  "meta": 11,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "torsemide",
   "Soaanz"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3010513,
  "beneficiaries": 739316,
  "spend": 59693571.12,
  "by_brand": [
   {
    "brand": "Torsemide",
    "claims": 2998501,
    "per_claim": 18.189032096,
    "is_generic": true
   },
   {
    "brand": "Soaanz",
    "claims": 12012,
    "per_claim": 429.04929987,
    "is_generic": false
   }
  ],
  "per_claim": 19.828371815700514
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8864,
  "fills": 3010513,
  "per_million": 2944.3486874163973,
  "ratio": 1.0633449319135717,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,944 FDA reports naming it as the suspect drug per million Medicare fills, 1.1x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 31,
   "letter": "F",
   "why": [
    "26 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 26% of completed registered trials posted results (-15)"
   ],
   "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 (12 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, general physical health deterioration, fatigue, dizziness. How would we recognize and handle those?",
  "Why this one over bumetanide, furosemide, piretanide? 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.)"
 ]
}