{
 "query": "bumetanide",
 "ingredient": "bumetanide",
 "slug": "bumetanide",
 "rxcui": "1808",
 "brands": [
  "Bumex",
  "Enbumyst"
 ],
 "names": [
  "bumetanide"
 ],
 "classes": [
  {
   "id": "C03CA",
   "name": "Sulfonamides, plain"
  }
 ],
 "alternatives": [
  "furosemide",
  "piretanide",
  "torsemide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 52,
   "INTRAMUSCULAR": 19,
   "INTRAVENOUS": 19,
   "NASAL": 1
  },
  "boxed_warning": "WARNING Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient's needs (see DOSAGE AND ADMINISTRATION ) .",
  "indications_and_usage": "INDICATIONS AND USAGE Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
  "contraindications": "CONTRAINDICATIONS Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Volume and Electrolyte Depletion The dose of bumetanide should be adjusted to the patient's need. Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Hypokalemia Hypokalemia can occur as a consequence of bumetanide administration. Prevention of hypokalemia requires particular attention in the following conditions: patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias. In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient's clinical status and electrolyte balance. Supplemental p...",
  "adverse_reactions": "ADVERSE REACTIONS The most frequent clinical adverse reactions considered probably or possibly related to bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide. Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use. Less frequent clinical adverse reactions to bumetanide are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with bumetanide. Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itc...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Bumetanide",
  "manufacturer": "Edenbridge Pharmaceuticals LLC.",
  "application_number": "NDA018225",
  "pharm_class_epc": [
   "Loop Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251217",
  "set_id": "32c4372e-54ea-4fc8-b9f8-827fa4c8edd3",
  "has_boxed_warning": true,
  "boxed_labels": "52 of 52",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 22389,
  "serious": 17048,
  "death": 3328,
  "hospitalization": 10621,
  "primary_suspect": 22335,
  "top_reactions": [
   [
    "Dyspnoea",
    2292
   ],
   [
    "Acute Kidney Injury",
    1783
   ],
   [
    "Fatigue",
    1587
   ],
   [
    "Death",
    1503
   ],
   [
    "Diarrhoea",
    1395
   ],
   [
    "Nausea",
    1296
   ],
   [
    "Headache",
    1124
   ],
   [
    "Dizziness",
    1109
   ],
   [
    "Pneumonia",
    958
   ],
   [
    "Chronic Kidney Disease",
    919
   ],
   [
    "Hypotension",
    888
   ],
   [
    "Renal Failure",
    846
   ],
   [
    "Off Label Use",
    843
   ],
   [
    "Asthenia",
    836
   ],
   [
    "Fall",
    799
   ]
  ],
  "by_year": {
   "2019": 2104,
   "2020": 2118,
   "2021": 1522,
   "2022": 1344,
   "2023": 1720,
   "2024": 2150,
   "2025": 2266,
   "2026": 1143
  },
  "by_year_primary": {
   "2019": 2102,
   "2020": 2118,
   "2021": 1522,
   "2022": 1335,
   "2023": 1714,
   "2024": 2134,
   "2025": 2255,
   "2026": 1135
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20131106",
   "reason": "Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.",
   "firm": "Sandoz Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 26,
  "nda": 3,
  "anda": 23,
  "first_approval": "19830228",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 18,
  "labeling_recent": 0,
  "sponsors": [
   "ADAPTIS",
   "AMNEAL PHARMS CO",
   "APPCO",
   "ASPIRO",
   "CORSTASIS THERAP",
   "GLAND",
   "HERITAGE PHARMA",
   "HOSPIRA"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/28/1983"
 },
 "trials": {
  "total": 50,
  "completed": 19,
  "terminated": 14,
  "with_results": 9,
  "industry": 13,
  "phase3": 9,
  "results_share": 0.47368421052631576,
  "terminated_share": 0.28
 },
 "pubmed": {
  "rct": 67,
  "meta": 6,
  "recent_rct": 14,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "bumetanide",
   "Bumex",
   "Enbumyst"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2403773,
  "beneficiaries": 570590,
  "spend": 78616303.29,
  "by_brand": [
   {
    "brand": "Bumetanide",
    "claims": 2403773,
    "per_claim": 32.705377459,
    "is_generic": true
   }
  ],
  "per_claim": 32.705377458686826
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "bumetanide",
  "matched": "bumetanide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5524,
  "fills": 2403773,
  "per_million": 2298.053934377331,
  "ratio": 0.8299370298184371,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 68,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,298 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death appears in 1.6x the share of reports seen across all of FAERS (-2)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 34,
   "letter": "F",
   "why": [
    "67 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 47% of completed registered trials posted results (-8)",
    "28% of registered trials were terminated, withdrawn, or suspended (-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 (23 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, acute kidney injury, fatigue, death. How would we recognize and handle those?",
  "Why this one over furosemide, piretanide, torsemide? 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.)"
 ]
}