pharmacopeia
GET
/api/v1/drug/digoxin
2D structure
3-[(3S,5R,8R,9S,10S,12R,13S,14S,17R)-3-[(2R,4S,5S,6R)-5-[(2S,4S,5S,6R)-5-[(2S,4S,5S,6R)-4,5-dihydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-6-methyloxan-2-yl]oxy-12,14-dihydroxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]-2H-furan-5-one
SMILES C[C@@H]1[C@H]([C@H](C[C@@H](O1)O[C@@H]2[C@H](O[C@H](C[C@@H]2O)O[C@@H]3[C@H](O[C@H](C[C@@H]3O)O[C@H]4CC[C@]5([C@@H](C4)CC[C@@H]6[C@@H]5C[C@H]([C@]7([C@@]6(CC[C@@H]7C8=CC(=O)OC8)O)C)O)C)C)C)O)O
InChIKey LTMHDMANZUZIPE-PUGKRICDSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Enzyme Inhibitors; Sodium-Potassium Exchanging ATPase Interactions.

Enzyme

Indications

Sourced from openFDA
  • & USAGE Digoxin 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.ICD-10: I50.9

Contraindications

Sourced from openFDA
  • Digoxin 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.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Digoxin dose is based on patient-specific factors (age, lean body weight, renal function, etc.). See full prescribing information. Monitor for toxicity and therapeutic effect. 2.1 Important Dosing and Administration Information In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose. Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4) ] . Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight. 2.2 Loading Dosing Regimen in Adults and Pediatric Patients For adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose. The recommended loading dose is displayed in Table 1. Table 1.

Warnings & precautions

Sourced from openFDA

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 digoxin 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 Digoxin may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.

Adverse reactions

Sourced from openFDA

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 Oliva Therapeutics at 1-877-200-6088 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 digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when digoxin is used within the recommended dose range, is maintained within the therapeutic serum concentration range, and when there is careful attention to concurrent medications and conditions.

Use in specific populations

Sourced from openFDA

Pregnant patients: It is unknown whether use during pregnancy can cause fetal harm. ( 8.1 ) Pediatric patients: Newborn infants display variability in tolerance to digoxin. ( 8.4 ) Geriatric patients: Consider renal function in dosage selection, and carefully monitor for side effects. ( 8.5 ) Renal impairment: Digoxin is excreted by the kidneys. Consider renal function during dosage selection. ( 8.6 ) 8.1 Pregnancy Risk Summary Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. Untreated underlying maternal conditions, such as heart failure and atrial fibrillation, during pregnancy pose a risk to the mother and fetus (see Clinical Consideration). Animal reproduction studies have not been conducted with digoxin. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Overdosage

Sourced from openFDA

10.1 Signs and Symptoms in Adults and Children The signs and symptoms of toxicity are generally similar to those described in the Adverse Reactions (6.1) but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become more frequent with levels above 2 ng/mL. However, in deciding whether a patient’s symptoms are due to digoxin, the clinical state together with serum electrolyte levels and thyroid function are important factors [see Dosage and Administration (2) ] . Adults: The most common signs and symptoms of digoxin toxicity are nausea, vomiting, anorexia, and fatigue that occur in 30-70% of patients who are overdosed. Extremely high serum concentrations produce hyperkalemia especially in patients with impaired renal function. Almost every type of cardiac arrhythmia has been associated with digoxin overdose and multiple rhythm disturbances in the same patient are common. Peak cardiac effects occur 3-6 hours following ingestion and may persist for 24 hours or longer.

Approval history

Sourced from openFDA
  • Nov 16, 1954NDANDA009330Azurity
  • Oct 24, 1975ANDAANDA083391Hikma
  • Sep 30, 1997NDANDA020405Advanz Pharma
  • Jul 26, 2002ANDAANDA076268Stevens J
  • Aug 21, 2003ANDAANDA040481Sandoz
  • Aug 26, 2004NDANDA021648Hikma
  • Oct 30, 2007ANDAANDA077002Hikma Intl Pharms
  • Jul 20, 2009ANDAANDA078556Impax Labs

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
70,809 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea6,1168.6%
  2. 2Nausea4,7836.8%
  3. 3Dizziness4,4816.3%
  4. 4Fatigue4,2035.9%
  5. 5Atrial Fibrillation3,9935.6%
  6. 6Diarrhoea3,7765.3%
  7. 7Asthenia3,6325.1%
  8. 8Death3,4324.8%
  9. 9Vomiting3,3774.8%
  10. 10Hypotension3,2004.5%
  11. 11Cardiac Failure Congestive3,1414.4%
  12. 12Pain3,0004.2%
  13. 13Fall2,9294.1%
  14. 14Drug Interaction2,8094.0%
  15. 15Pneumonia2,7383.9%

Literature

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Recent PubMed references pinned to Digoxin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 288 ClinicalTrials.gov registrations naming Digoxin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Digoxin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • ABCB1CPIC C (provisional)ClinPGx 3

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Digoxin work?
Mechanism-of-action classes: Enzyme Inhibitors; Sodium-Potassium Exchanging ATPase Interactions.
What is Digoxin used for?
According to FDA labeling, Digoxin carries indications including: & USAGE Digoxin 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Digoxin?
Digoxin is classified as Digitalis glycosides, Cardiac Glycoside, Enzyme Inhibitors, Sodium-Potassium Exchanging ATPase Interactions, Conduction System Depolarization, Negative Chronotropy, Nodal Depolarization, Positive Inotropy.
What are the brand names for Digoxin?
Digoxin is marketed under brand names including Digitek, Digox, Lanoxin.
What are the contraindications for Digoxin?
Digoxin labeling lists contraindications including: Digoxin 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.. Always consult the full prescribing information and a clinician.
Note. Data for digoxin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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