Lanoxin tablet/adverse reactions

Lanoxin tablet®
Black Box Warning
Adult Indications and Dosage   FDA-Labeled Use   Off-Label Use
Pediatric Indications and Dosage   FDA-Labeled Use   Off-Label Use
Contraindications
Warnings
Adverse Reactions   Clinical Trials Experience   Postmarketing Experience
Drug Interactions
Use in Specific Populations   Pregnancy   Labor and Delivery   Nursing Mothers   Pediatric Use   Geriatric Use   Gender   Race   Renal Impairment   Hepatic Impairment   Females of Reproductive     Potential and Males   Immunocompromised Patients
Routes and Preparations   Routes   Preparations
IV Compatibility
Overdosage
Pharmacology   Mechanism of Action   Structure   Pharmacodynamics   Pharmacokinetics   Nonclinical Toxicology
Clinical Studies
How Supplied
Images   Drug Images   Package & Label Display Panel
Patient Information   Patient Information from FDA   Patient Information from NLM
Combined Alcohol Use
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

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 or therapeutic serum concentration range and when there is careful attention to concurrent medications and conditions.

Because some patients may be particularly susceptible to side effects with digoxin, the dosage of the drug should always be selected carefully and adjusted as the clinical condition of the patient warrants. In the past, when high doses of digoxin were used and little attention was paid to clinical status or concurrent medications, adverse reactions to digoxin were more frequent and severe. Cardiac adverse reactions accounted for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse reactions. However, available evidence suggests that the incidence and severity of digoxin toxicity has decreased substantially in recent years. In recent controlled clinical trials, in patients with predominantly mild to moderate heart failure, the incidence of adverse experiences was comparable in patients taking digoxin and in those taking placebo. In a large mortality trial, the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking LANOXIN compared to 0.9% in patients taking placebo. In this trial, the most common manifestations of digoxin toxicity included gastrointestinal and cardiac disturbances; CNS manifestations were less common.

Clinical Trials Experience

Cardiac

Arrhythmia( first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation).

Gastrointestinal

anorexia, nausea, vomiting, and diarrhea

Neurologic

visual disturbances (blurred or yellow vision), headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).

Other adverse reactions

Gynecomastia, thrombocytopenia and maculopapular rash.

Postmarketing Experience

FDA Package Insert for Lanoxin tablet contains no information regarding 'Postmarketing Experience'.