{
 "query": "digoxin",
 "ingredient": "digoxin",
 "slug": "digoxin",
 "rxcui": "3407",
 "brands": [
  "Lanoxin",
  "Digox"
 ],
 "names": [
  "digoxin"
 ],
 "classes": [
  {
   "id": "C01AA",
   "name": "Digitalis glycosides"
  }
 ],
 "alternatives": [
  "acetyldigitoxin",
  "acetyldigoxins",
  "deslanoside",
  "digitalis leaf extract",
  "digitoxin",
  "lanatoside c",
  "medigoxin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 34,
   "INTRAMUSCULAR": 9,
   "INTRAVENOUS": 9,
   "PARENTERAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3 ) 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Heart Failure in Pediatric Patients LANOXIN increases myocardial contractility in pediatric patients with heart failure. 1.3 Atrial Fibrillation in Adults LANOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.",
  "contraindications": "is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin. Ventricular fibrillation. ( 4 ) Known hypersensitivity to digoxin or other forms of digitalis. ( 4 )",
  "warnings_and_cautions": "Risk of rapid ventricular response leading to ventricular fibrillation in patients with AV accessory pathway. ( 5.1 ) Risk of advanced or complete heart block in patients with sinus node disease and AV block. ( 5.2 ) Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias. Advanced age, low body weight, impaired renal function and electrolyte abnormalities predispose to toxicity. ( 5.3 ) Risk of ventricular arrhythmias during electrical cardioversion. ( 5.4 ) Not recommended in patients with acute myocardial infarction. ( 5.5 ) Avoid LANOXIN in patients with myocarditis. ( 5.6 ) 5.1 Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff-Parkinson-White Syndrome) Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response leading to ventricular fibrillation are thereby increased. 5.2 Sinus Bradycardia and Sino-atrial Block LANOXIN may cause severe sinus bradycardia or sinoatrial block partic...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are included in more detail in the Warnings and Precautions section of the label: Cardiac arrhythmias [see Warnings and Precautions ( 5.1 , 5.2 )] Digoxin Toxicity [see Warnings and Precautions ( 5.3 )] The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142 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 clinical practice. In general, the adverse reactions of LANOXIN are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when LANOXIN is use...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients that digoxin is used to treat heart failure and heart arrhythmias. Instruct patients to take this medication as directed. Advise patients that many drugs can interact with LANOXIN. Instruct patients to inform their doctor and pharmacist if they are taking any over the counter medications, including herbal medication, or are started on a new prescription. Advise patient that blood tests will be necessary to ensure that their LANOXIN dose is appropriate for them. Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of LANOXIN may be too high. Advise parents or caregivers that the symptoms of having too high LANOXIN doses may be difficult to recognize in infants and pediatric patients. Symptoms such as weight loss, failure to thrive in infants, abdominal pain, and behavioral disturbances may be indications of digoxin toxicity. Instruct the patient to monitor and record their heart rate and blood pressure daily. Instruct women of childbearing p...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Chronic Heart Failure Two 12-week, double-blind, placebo-controlled studies enrolled 178 (RADIANCE trial) and 88 (PROVED trial) adult patients with NYHA Class II or III heart failure previously treated with oral digoxin, a diuretic, and an ACE inhibitor (RADIANCE only) and randomized them to placebo or treatment with LANOXIN Tablets. Both trials demonstrated better preservation of exercise capacity in patients randomized to LANOXIN. Continued treatment with LANOXIN reduced the risk of developing worsening heart failure, as evidenced by heart failure-related hospitalizations and emergency care and the need for concomitant heart failure therapy. DIG Trial of LANOXIN in Patients with Heart Failure The Digitalis Investigation Group (DIG) main trial was a 37-week, multicenter, randomized, double-blind mortality study comparing digoxin to placebo in 6800 adult patients with heart failure and left ventricular ejection fraction less than or equal to 0.45. At randomization, 67% were NYHA class I or II, 71% had heart failure of ischemic etiology, 44% had been receiving digoxin, and most were receiving a concomitant ACE inhibitor (94%) and diuretics (82%). As in the smaller trials descri...",
  "brand_name": "LANOXIN",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA020405",
  "pharm_class_epc": [
   "Cardiac Glycoside [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20190508",
  "set_id": "f6c7ca21-1c76-4838-8fb9-e1bec6001d8b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 42294,
  "serious": 34949,
  "death": 7028,
  "hospitalization": 21798,
  "primary_suspect": 42056,
  "top_reactions": [
   [
    "Dyspnoea",
    3526
   ],
   [
    "Fatigue",
    2560
   ],
   [
    "Diarrhoea",
    2449
   ],
   [
    "Nausea",
    2351
   ],
   [
    "Dizziness",
    2135
   ],
   [
    "Death",
    2099
   ],
   [
    "Acute Kidney Injury",
    1973
   ],
   [
    "Off Label Use",
    1827
   ],
   [
    "Atrial Fibrillation",
    1812
   ],
   [
    "Toxicity To Various Agents",
    1770
   ],
   [
    "Headache",
    1766
   ],
   [
    "Drug Interaction",
    1756
   ],
   [
    "Vomiting",
    1752
   ],
   [
    "Malaise",
    1677
   ],
   [
    "Drug Ineffective",
    1640
   ]
  ],
  "by_year": {
   "2019": 3911,
   "2020": 3437,
   "2021": 2448,
   "2022": 1872,
   "2023": 2317,
   "2024": 2195,
   "2025": 2114,
   "2026": 937
  },
  "by_year_primary": {
   "2019": 3903,
   "2020": 3425,
   "2021": 2433,
   "2022": 1826,
   "2023": 2266,
   "2024": 2152,
   "2025": 2074,
   "2026": 923
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240325",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "Novitium Pharma LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20240304",
   "reason": "Cross Contamination with Other Products:(mycophenolate mofetil).",
   "firm": "Novitium Pharma LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 20,
  "nda": 4,
  "anda": 15,
  "first_approval": "19541116",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 39,
  "labeling_recent": 6,
  "sponsors": [
   "ABRAXIS PHARM",
   "ADVANZ PHARMA",
   "AUROBINDO PHARMA LTD",
   "AZURITY",
   "GLAXOSMITHKLINE LLC",
   "HIKMA",
   "HOSPIRA",
   "IMPAX LABS"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/16/1954"
 },
 "trials": {
  "total": 295,
  "completed": 215,
  "terminated": 20,
  "with_results": 51,
  "industry": 178,
  "phase3": 14,
  "results_share": 0.2372093023255814,
  "terminated_share": 0.06779661016949153
 },
 "pubmed": {
  "rct": 395,
  "meta": 36,
  "recent_rct": 15,
  "cochrane": [
   {
    "pmid": "21249645",
    "title": "Digoxin for preventing or treating neonatal respiratory distress syndrome",
    "year": "2011"
   },
   {
    "pmid": "10796245",
    "title": "Digoxin for preventing or treating neonatal respiratory distress syndrome",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "digoxin",
   "Lanoxin",
   "Digox"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1580892,
  "beneficiaries": 371086,
  "spend": 37827086.6,
  "by_brand": [
   {
    "brand": "Digoxin",
    "claims": 1579920,
    "per_claim": 23.330428534,
    "is_generic": true
   },
   {
    "brand": "Lanoxin",
    "claims": 972,
    "per_claim": 994.72834362,
    "is_generic": false
   }
  ],
  "per_claim": 23.927685509193545
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "digoxin",
  "matched": "digoxin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5149,
  "fills": 1580892,
  "per_million": 3257.0219850565377,
  "ratio": 1.1762661928400724,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 96,
   "letter": "A",
   "why": [
    "3,257 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "395 randomized trials and 36 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III across 15 generic makers (-1)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "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 (15 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over acetyldigitoxin, acetyldigoxins, deslanoside? 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.)"
 ]
}