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Digoxin Dosing Errors, Drug Interactions and Off-Label Risks: Insights from an EudraVigilance Disproportionality
Emilia Sorina Fiat1,2, Laurentiu Stoicescu3, Ioana Rada Popa Ilie4
1Doctoral School, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Journal of Clinical Medicine
|August 13, 2026
Summary
Digoxin use in heart failure patients leads to significant adverse events, particularly drug interactions and overdoses, especially in the elderly. Careful monitoring and dose adjustments are crucial to mitigate digoxin toxicity risks.
Area of Science:
- Pharmacovigilance
- Cardiology
- Geriatrics
Background:
- Digoxin, a narrow therapeutic index inotropic agent, is prescribed for heart failure.
- Digoxin use is associated with significant risks, including toxicity and adverse drug reactions.
- Understanding digoxin's safety profile is critical for patient management.
Purpose of the Study:
- To analyze digoxin-associated adverse drug reactions (ADRs) reported in the EudraVigilance database.
- To investigate drug-drug interactions, dosing errors, and off-label use of digoxin.
- To characterize the ADR profile of digoxin compared to other inotropic agents.
Main Methods:
- Descriptive and disproportionality analyses of Individual Case Safety Reports (ICSRs).
- Comparison of digoxin with other inotropic agents using Reporting Odds Ratio (ROR).
- Data analysis included ICSRs up to January 25, 2026.
Main Results:
- 11,426 digoxin-related ICSRs were reported, predominantly in elderly patients (65-85 and >85 years).
- Higher reporting probabilities for 'Drug interaction' and 'Overdose' were observed compared to other inotropes.
- Fatal outcomes linked to drug interactions (19 cases) and overdose (41 cases); gastrointestinal, renal, and nervous system disorders were consistently signaled. Off-label use (0.8%) correlated with poor outcomes.
Conclusions:
- Digoxin toxicity and cardiac complications are major causes of morbidity.
- Elderly patients with polypharmacy and renal decline face exacerbated risks.
- Rigorous clinical monitoring, precise dosing, and vigilance for drug interactions are essential for safe digoxin use.
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