{
 "query": "spironolactone",
 "ingredient": "spironolactone",
 "slug": "spironolactone",
 "rxcui": "9997",
 "brands": [
  "Aldactone",
  "Carospir"
 ],
 "names": [
  "spironolactone"
 ],
 "classes": [
  {
   "id": "C03DA",
   "name": "Aldosterone antagonists"
  }
 ],
 "alternatives": [
  "canrenoate potassium",
  "canrenone",
  "eplerenone",
  "finerenone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 134
  },
  "boxed_warning": "",
  "indications_and_usage": "is an aldosterone antagonist indicated for: \u2022 The treatment of NYHA Class III\u2013IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). \u2022 Use as an add-on therapy 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 ( 1.2 ). \u2022 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3 ). \u2022 Treatment of primary hyperaldosternism for: ( 1.4 ) o Short-term preoperative treatment o Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia 1.1 Heart Failure ALDACTONE is indicated for treatment of NYHA Class III\u2013IV heart failure and reduced ejection fraction to increase surviva...",
  "contraindications": "is contraindicated in the patients with: \u2022 Hyperkalemia \u2022 Addison's disease \u2022 Concomitant use of eplerenone ALDACTONE is contraindicated in patients with ( 4 ): \u25aa Hyperkalemia \u25aa Addison's disease \u25aa Concomitant use of eplerenone",
  "warnings_and_cautions": "\u2022 Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1 ). \u2022 Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2 ). \u2022 Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3 ). \u2022 Gynecomastia: ALDACTONE can cause gynecomastia ( 5.4 ). 5.1 Hyperkalemia ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . Monitor serum potassium within 1 week of initiation or titration of ALDACTONE and regularly thereafter. More frequent monitoring may be needed when ALDACTONE is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue ALDACTONE and treat hyperkalemia. 5.2 Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal func...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Hyperkalemia [see Warnings and Precautions (5.1) ] \u2022 Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2) ] \u2022 Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3) ] \u2022 Gynecomastia [see Warnings and Precautions (5.4 ] \u2022 Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7) ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes. This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com . LAB-0231-18.0 Logo",
  "spl_medguide": "",
  "clinical_studies": "14.1 Heart Failure The Randomized Aldactone Evaluation Study (RALES) was a placebo controlled, double-blind study of the effect of spironolactone on mortality in patients with highly symptomatic heart failure and reduced ejection fraction. To be eligible to participate patients had to have an ejection fraction of \u2264 35%, NYHA class III\u2013IV symptoms, and a history of NYHA class IV symptoms within the last 6 months before enrollment. Patients with a baseline serum creatinine of >2.5 mg/dL or a recent increase of 25% or with a baseline serum potassium of >5.0 mEq/L were excluded. Follow-up visits and laboratory measurements (including serum potassium and creatinine) were performed every four weeks for the first 12 weeks, then every 3 months for the first year, and then every 6 months thereafter. The initial dose of spironolactone was 25 mg once daily. Patients who were intolerant of the initial dosage regimen had their dose decreased to one 25 mg tablet every other day at one to four weeks. Patients who were tolerant of one tablet daily at 8 weeks may have had their dose increased to 50 mg daily at the discretion of the investigator. The mean daily dose at study end for patients randomi...",
  "brand_name": "Aldactone",
  "manufacturer": "Pfizer Laboratories Div Pfizer Inc",
  "application_number": "NDA012151",
  "pharm_class_epc": [
   "Aldosterone Antagonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251128",
  "set_id": "0fed2822-3a03-4b64-9857-c682fcd462bc",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 120104,
  "serious": 93023,
  "death": 14816,
  "hospitalization": 55575,
  "primary_suspect": 119261,
  "top_reactions": [
   [
    "Dyspnoea",
    9389
   ],
   [
    "Fatigue",
    7704
   ],
   [
    "Acute Kidney Injury",
    7403
   ],
   [
    "Nausea",
    6908
   ],
   [
    "Diarrhoea",
    6875
   ],
   [
    "Off Label Use",
    5943
   ],
   [
    "Dizziness",
    5635
   ],
   [
    "Headache",
    5618
   ],
   [
    "Hypotension",
    5091
   ],
   [
    "Drug Ineffective",
    4837
   ],
   [
    "Death",
    4648
   ],
   [
    "Fall",
    4378
   ],
   [
    "Asthenia",
    4170
   ],
   [
    "Vomiting",
    4158
   ],
   [
    "Pneumonia",
    3939
   ]
  ],
  "by_year": {
   "2019": 11378,
   "2020": 10568,
   "2021": 9564,
   "2022": 8889,
   "2023": 9781,
   "2024": 10736,
   "2025": 10670,
   "2026": 5327
  },
  "by_year_primary": {
   "2019": 11363,
   "2020": 10543,
   "2021": 9516,
   "2022": 8702,
   "2023": 9592,
   "2024": 10619,
   "2025": 10497,
   "2026": 5253
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250805",
   "reason": "Presence of foreign substance: identified as aluminum.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20130904",
   "reason": "Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the al",
   "firm": "Pfizer Us Pharmaceutical Group",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 29,
  "nda": 2,
  "anda": 19,
  "first_approval": "19600121",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 27,
  "labeling_recent": 4,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "AMNEAL",
   "AMNEAL PHARMS",
   "ANNORA PHARMA",
   "ASCOT",
   "AUROBINDO PHARMA",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/21/1960"
 },
 "trials": {
  "total": 330,
  "completed": 163,
  "terminated": 43,
  "with_results": 53,
  "industry": 50,
  "phase3": 54,
  "results_share": 0.32515337423312884,
  "terminated_share": 0.1303030303030303
 },
 "pubmed": {
  "rct": 396,
  "meta": 40,
  "recent_rct": 76,
  "cochrane": [
   {
    "pmid": "20687095",
    "title": "Spironolactone for hypertension",
    "year": "2010"
   },
   {
    "pmid": "19370553",
    "title": "Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne",
    "year": "2009"
   },
   {
    "pmid": "14583916",
    "title": "Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne",
    "year": "2003"
   },
   {
    "pmid": "11687072",
    "title": "Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne",
    "year": "2001"
   },
   {
    "pmid": "10796700",
    "title": "Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "spironolactone",
   "Aldactone",
   "Carospir"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9082905,
  "beneficiaries": 2366486,
  "spend": 81238913.17,
  "by_brand": [
   {
    "brand": "Spironolactone",
    "claims": 9081323,
    "per_claim": 8.8780375514,
    "is_generic": true
   },
   {
    "brand": "Aldactone",
    "claims": 1291,
    "per_claim": 331.98031758,
    "is_generic": false
   },
   {
    "brand": "Carospir",
    "claims": 291,
    "per_claim": 639.17515464,
    "is_generic": false
   }
  ],
  "per_claim": 8.944155330260529
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "spironolactone",
  "matched": "spironolactone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 26369,
  "fills": 9082905,
  "per_million": 2903.1460749617004,
  "ratio": 1.0484647007362835,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,903 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "396 randomized trials and 40 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist",
    "Only 33% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 19 generic makers (-1)",
    "4 label changes approved since 2021 (-4)"
   ],
   "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 (19 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, acute kidney injury, nausea. 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 canrenoate potassium, canrenone, eplerenone? 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.)"
 ]
}