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What the label lists and what reports show

Digoxin side effects

Digoxin's FDA label lists its adverse reactions in its own words. FAERS holds 71,335 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (6,182 reports).

  • Generic listed

Check it at the source: the digoxin FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.

What does the label list?

From the label: 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 Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set d91e3646-4c63-4512-ab22-db39c085c4dc), via openFDA; the full label on DailyMed

What do FAERS reports show?

71,335 reports list digoxin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13,780 are coded as a death and 36,261 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Dyspnoea6,182
  • Nausea (named in the label)4,837
  • Dizziness (named in the label)4,539
  • Fatigue4,263
  • Atrial Fibrillation (a use or a product term, not a reaction)4,040
  • Diarrhoea3,855
  • Asthenia3,650
  • Death (an outcome recorded in the report)3,447
  • Vomiting (named in the label)3,423
  • Hypotension3,234
  • Cardiac Failure Congestive3,146
  • Pain3,045
  • Fall2,948
  • Drug Interaction (a use or a product term, not a reaction)2,830
  • Pneumonia2,756
  • Headache (named in the label)2,682
  • Malaise2,611
  • Bradycardia (named in the label)2,534
  • Toxicity To Various Agents2,435
  • Drug Ineffective (a use or a product term, not a reaction)2,410
  • Chest Pain2,259
  • Anaemia2,205
  • Myocardial Infarction2,196
  • Renal Failure2,154
  • Anxiety (named in the label)2,121

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Digoxin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions