{
 "query": "metolazone",
 "ingredient": "metolazone",
 "slug": "metolazone",
 "rxcui": "6916",
 "brands": [],
 "names": [
  "metolazone"
 ],
 "classes": [
  {
   "id": "C03BA",
   "name": "Sulfonamides, plain"
  }
 ],
 "alternatives": [
  "chlorthalidone",
  "clopamide",
  "indapamide",
  "mefruside",
  "quinethazone",
  "xipamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 30
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Metolazone tablets, USP, are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. Usage In Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indica...",
  "contraindications": "CONTRAINDICATIONS Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Rapid Onset Hyponatremia And/Or Hypokalemia Rarely, the rapid onset of severe hyponatremia and/or hypokalemia has been reported following initial doses of thiazide and non-thiazide diuretics. When symptoms consistent with severe electrolyte imbalance appear rapidly, drug should be discontinued and supportive measures should be initiated immediately. Parenteral electrolytes may be required. Appropriateness of therapy with this class of drugs should be carefully reevaluated. Hypokalemia Hypokalemia may occur with consequent weakness, cramps, and cardiac dysrhythmias. Serum potassium should be determined at regular and appropriate intervals, and dose reduction, potassium supplementation or addition of a potassium-sparing diuretic instituted whenever indicated. Hypokalemia is a particular hazard in patients who are digitalized or who have or have had a ventricular arrhythmia; dangerous or fatal arrhythmias may be precipitated. Hypokalemia is dose related. Concomitant Therapy Lithium In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium prepar...",
  "adverse_reactions": "ADVERSE REACTIONS Metolazone tablets, USP, are usually well tolerated, and most reported adverse reactions have been mild and transient. Many of metolazone tablets, USP, related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or its renal/metabolic actions. The following adverse reactions have been reported. Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems. Cardiovascular Chest pain/discomfort, orthostatic hypotension, excessive volume depletion, hemoconcentration, venous thrombosis, palpitations. Central And Peripheral Nervous System Syncope, neuropathy, vertigo, paresthesias, psychotic depression, impotence, dizziness/lightheadedness, drowsiness, fatigue, weakness, restlessness (sometimes resulting in insomnia), headache. Dermatologic/Hypersensitivity Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis (photosensitivity), urticaria, pruritus, skin rashes. Gastrointestinal Hepatitis, intrahepatic cholestatic jaund...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information For Patients Patients should be informed of possible adverse effects, advised to take the medication as directed, and promptly report any possible adverse reactions to the treating physician.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "METOLAZONE",
  "manufacturer": "Advagen Pharma Limited",
  "application_number": "ANDA215184",
  "pharm_class_epc": [
   "Thiazide-like Diuretic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260115",
  "set_id": "6a9c8415-e389-7a9a-73de-532cf3f57ac5",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 10341,
  "serious": 8131,
  "death": 2030,
  "hospitalization": 5297,
  "primary_suspect": 10332,
  "top_reactions": [
   [
    "Dyspnoea",
    1167
   ],
   [
    "Acute Kidney Injury",
    954
   ],
   [
    "Death",
    861
   ],
   [
    "Chronic Kidney Disease",
    669
   ],
   [
    "Renal Failure",
    659
   ],
   [
    "Nausea",
    642
   ],
   [
    "Diarrhoea",
    629
   ],
   [
    "Fatigue",
    628
   ],
   [
    "Headache",
    570
   ],
   [
    "Cardiac Failure Congestive",
    560
   ],
   [
    "Hypotension",
    556
   ],
   [
    "Dizziness",
    520
   ],
   [
    "Fluid Retention",
    496
   ],
   [
    "Fall",
    485
   ],
   [
    "Asthenia",
    460
   ]
  ],
  "by_year": {
   "2019": 1051,
   "2020": 978,
   "2021": 722,
   "2022": 459,
   "2023": 570,
   "2024": 715,
   "2025": 723,
   "2026": 301
  },
  "by_year_primary": {
   "2019": 1050,
   "2020": 978,
   "2021": 722,
   "2022": 454,
   "2023": 570,
   "2024": 713,
   "2025": 722,
   "2026": 301
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 17,
  "nda": 3,
  "anda": 14,
  "first_approval": "19731127",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 26,
  "labeling_recent": 0,
  "sponsors": [
   "ACERTIS PHARMS",
   "ALEMBIC",
   "ANI PHARMS",
   "CHARTWELL MOLECULAR",
   "GD SEARLE LLC",
   "I3 PHARMS",
   "INNOGENIX",
   "MICRO LABS"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/27/1973"
 },
 "trials": {
  "total": 36,
  "completed": 10,
  "terminated": 13,
  "with_results": 8,
  "industry": 6,
  "phase3": 5,
  "results_share": 0.8,
  "terminated_share": 0.3611111111111111
 },
 "pubmed": {
  "rct": 12,
  "meta": 1,
  "recent_rct": 2,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "metolazone"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 646377,
  "beneficiaries": 212241,
  "spend": 14324829.55,
  "by_brand": [
   {
    "brand": "Metolazone",
    "claims": 646377,
    "per_claim": 22.161725355,
    "is_generic": true
   }
  ],
  "per_claim": 22.16172535532669
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1736,
  "fills": 646377,
  "per_million": 2685.739127475142,
  "ratio": 0.9699486687321102,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "2,686 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death appears in 2.2x the share of reports seen across all of FAERS (-8)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 21,
   "letter": "F",
   "why": [
    "12 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "36% 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 (14 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, acute kidney injury, death, chronic kidney disease. How would we recognize and handle those?",
  "Why this one over chlorthalidone, clopamide, indapamide? 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.)"
 ]
}