{
 "query": "furosemide",
 "ingredient": "furosemide",
 "slug": "furosemide",
 "rxcui": "4603",
 "brands": [
  "Lasix",
  "Furoscix"
 ],
 "names": [
  "furosemide"
 ],
 "classes": [
  {
   "id": "C03CA",
   "name": "Sulfonamides, plain"
  }
 ],
 "alternatives": [
  "bumetanide",
  "piretanide",
  "torsemide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 93,
   "INTRAVENOUS": 48,
   "INTRAMUSCULAR": 31,
   "SUBCUTANEOUS": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequat...",
  "contraindications": "CONTRAINDICATIONS Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.",
  "warnings_and_cautions": "",
  "warnings": "WARNING Furosemide 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 dose schedule must be adjusted to the individual patient's needs (see DOSAGE AND ADMINISTRATION ). WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe ...",
  "adverse_reactions": "ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 2. pancreatitis 3. jaundice (intrahepatic cholestatic jaundice) 4. increased liver enzymes 5. anorexia 6. oral and gastric irritation 7. cramping 8. diarrhea 9. constipation 10. nausea 11. vomiting Systemic Hypersensitivity Reactions 1. severe anaphylactic or anaphylactoid reactions (e.g., with shock) 2. systemic vasculitis 3. interstitial nephritis 4. necrotizing angiitis Central Nervous System Reactions 1. tinnitus and hearing loss 2. paresthesias 3. vertigo 4. dizziness 5. headache 6. blurred vision 7. xanthopsia Hematologic Reactions 1. aplastic anemia 2. thrombocytopenia 3. agranulocytosis 4. hemolytic anemia 5. leukopenia 6. anemia 7. eosinophilia Dermatologic-Hypersensitivity Reactions 1. toxic epidermal necrolysis 2. Stevens-Johnson Syndrome 3. erythema multiforme 4. drug rash with eosinophilia and systemic symptoms 5. acute generalized exanthematous pustulosis 6. exfoliative dermatitis 7. bullous pemphigoid 8. purpura 9. photosensitivity 10. rash 11. pruritus 12...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients receiving furosemide should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia. Patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide. Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Furosemide",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA076796",
  "pharm_class_epc": [
   "Loop Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20180418",
  "set_id": "1d2733ac-6fa6-44d1-96d4-f1a698045ad2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 318724,
  "serious": 258960,
  "death": 47208,
  "hospitalization": 156196,
  "primary_suspect": 317023,
  "top_reactions": [
   [
    "Dyspnoea",
    23487
   ],
   [
    "Acute Kidney Injury",
    21285
   ],
   [
    "Fatigue",
    17507
   ],
   [
    "Diarrhoea",
    16877
   ],
   [
    "Death",
    15733
   ],
   [
    "Off Label Use",
    14371
   ],
   [
    "Nausea",
    14364
   ],
   [
    "Fall",
    13406
   ],
   [
    "Pneumonia",
    12743
   ],
   [
    "Hypotension",
    12050
   ],
   [
    "Drug Ineffective",
    12025
   ],
   [
    "Dizziness",
    11570
   ],
   [
    "Asthenia",
    11379
   ],
   [
    "Headache",
    11146
   ],
   [
    "Pain",
    9683
   ]
  ],
  "by_year": {
   "2019": 33650,
   "2020": 29790,
   "2021": 25532,
   "2022": 20976,
   "2023": 20809,
   "2024": 21794,
   "2025": 20268,
   "2026": 9491
  },
  "by_year_primary": {
   "2019": 33605,
   "2020": 29753,
   "2021": 25401,
   "2022": 20639,
   "2023": 20434,
   "2024": 21492,
   "2025": 19955,
   "2026": 9376
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260320",
   "reason": "CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.",
   "firm": "Leading Pharma, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260110",
   "reason": "Presence of Foreign Substance",
   "firm": "Graviti Pharmaceuticals Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20161222",
   "reason": "Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.",
   "firm": "Roxane Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150925",
   "reason": "CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150925",
   "reason": "CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130226",
   "reason": "Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130110",
   "reason": "Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial",
   "firm": "Hospira, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 73,
  "nda": 26,
  "anda": 39,
  "first_approval": "19660701",
  "rems": false,
  "rems_last": "19750320",
  "labeling_supplements": 147,
  "labeling_recent": 9,
  "sponsors": [
   "ABRAXIS PHARM",
   "ACCORD HLTHCARE",
   "AM REGENT",
   "AMNEAL PHARMS CO",
   "ANI PHARMS",
   "APOTEX",
   "AREVA PHARMS",
   "ASPIRO"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/01/1966"
 },
 "trials": {
  "total": 438,
  "completed": 228,
  "terminated": 70,
  "with_results": 82,
  "industry": 98,
  "phase3": 75,
  "results_share": 0.35964912280701755,
  "terminated_share": 0.1598173515981735
 },
 "pubmed": {
  "rct": 405,
  "meta": 53,
  "recent_rct": 43,
  "cochrane": [
   {
    "pmid": "23740566",
    "title": "Furosemide for transient tachypnoea of the newborn",
    "year": "2013"
   },
   {
    "pmid": "11869651",
    "title": "Furosemide for transient tachypnea of the newborn",
    "year": "2002"
   },
   {
    "pmid": "11686979",
    "title": "Furosemide for symptomatic patent ductus arteriosus in indomethacin-treated infants",
    "year": "2001"
   },
   {
    "pmid": "10796253",
    "title": "Furosemide for symptomatic patent ductus arteriosus in indomethacin-treated infants",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 974216.76,
  "records": 13365,
  "by_name": [
   [
    "Furoscix",
    974216.76
   ]
  ],
  "names_checked": [
   "furosemide",
   "Lasix",
   "Furoscix"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 23564693,
  "beneficiaries": 5795519,
  "spend": 146616106.95000002,
  "by_brand": [
   {
    "brand": "Furosemide",
    "claims": 23553663,
    "per_claim": 5.0492663137,
    "is_generic": true
   },
   {
    "brand": "Lasix",
    "claims": 6667,
    "per_claim": 76.111517924,
    "is_generic": false
   },
   {
    "brand": "Furoscix",
    "claims": 4363,
    "per_claim": 6229.6480197,
    "is_generic": false
   }
  ],
  "per_claim": 6.221855169087076
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "furosemide",
  "matched": "furosemide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 50823,
  "fills": 23564693,
  "per_million": 2156.743565468899,
  "ratio": 0.778903106680254,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 98,
   "letter": "A",
   "why": [
    "2,157 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": 73,
   "letter": "C",
   "why": [
    "405 randomized trials and 53 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 36% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 39 generic makers (-4)",
    "9 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $974,217 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (39 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, acute kidney injury, fatigue, diarrhoea. 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 bumetanide, 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.)"
 ]
}