Lanoxin Side Effects

Generic Name: digoxin

Please note - some side effects for Lanoxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lanoxin - for the Consumer

Lanoxin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lanoxin:

Diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, yellow vision, or other vision changes; confusion; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; unusual tiredness or weakness.

Lanoxin Capsules

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lanoxin Capsules:

Diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, yellow vision, or other vision changes; confusion; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; unusual tiredness or weakness.

Lanoxin Elixir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lanoxin Elixir:

Diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, yellow vision, or other vision changes; confusion; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; unusual tiredness or weakness.

Lanoxin Side Effects - for the Professional

Lanoxin

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 Tablets 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.

Adults:

Therapeutic doses of digoxin may cause heart block in patients with pre-existing sinoatrial or AV conduction disorders; heart block can be avoided by adjusting the dose of digoxin. Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered unacceptable. High doses of digoxin may produce a variety of rhythm disturbances, such as 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. Digoxin produces PR prolongation and ST segment depression which should not by themselves be considered digoxin toxicity. Cardiac toxicity can also occur at therapeutic doses in patients who have conditions which may alter their sensitivity to digoxin.

 Digoxin may cause anorexia, nausea, vomiting, and diarrhea. Rarely, the use of digoxin has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.

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

Gynecomastia has been occasionally observed following the prolonged use of digoxin. Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed.

Table 4 summarizes the incidence of those adverse experiences listed above for patients treated with Lanoxin Tablets or placebo from 2 randomized, double-blind, placebo-controlled withdrawal trials. Patients in these trials were also receiving diuretics with or without angiotensin-converting enzyme inhibitors. These patients had been stable on digoxin, and were randomized to digoxin or placebo. The results shown in Table 4 reflect the experience in patients following dosage titration with the use of serum digoxin concentrations and careful follow-up. These adverse experiences are consistent with results from a large, placebo-controlled mortality trial (DIG trial) wherein over half the patients were not receiving digoxin prior to enrollment.

Infants and Children

The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with digoxin in infants and children is the appearance of cardiac arrhythmias, including sinus bradycardia. In children, the use of digoxin may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending digoxin intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.

Side Effects by Body System

General

Side effects generally have been dose-related and occurred more frequently when serum digoxin levels exceed 2.0 ng/mL. Cardiovascular (50%), gastrointestinal (25%), and CNS symptoms (25%) have been reported most often.

Patients at increased risk include those with underlying renal, cardiopulmonary, or thyroid disease, electrolyte imbalances such as hypokalemia, hypomagnesemia, or hypercalcemia, and patients greater than 65 years of age.

Gastrointestinal

Gastrointestinal side effects reported in 25% of patients have included anorexia, nausea, vomiting, diarrhea, and general abdominal pain. Rarely, intestinal ischemia or hemorrhagic necrosis, dysphagia, and esophageal dystonia have been reported.

Cases of severe abdominal pain and documented intestinal ischemia have been reported in patients after hemodialysis. Contraction of intravascular volume combined with digoxin-induced splanchnic vasoconstriction may induce abdominal pain.

Cardiovascular

Cardiovascular side effects have been reported the most frequently. These have included premature ventricular depolarizations (50%), AV nodal arrhythmias (50%), AV conduction disturbances (36%), wide complex tachycardia (less than 1%), paroxysmal atrial tachycardia with AV block, complete heart block, PR prolongation, and ST segment changes.

Ocular

Ocular side effects have included chromatopsia, snowy or blurry vision, photopsia, and decreased visual acuity. Rarely, transient blindness has been reported. Decreased color vision has been reported.

The development of photopsia characterized by innumerable points of light in the peripheral visual fields or a decrease in visual acuity has been associated with therapeutic serum digitalis concentrations in the elderly. Digitalis-induced visual disturbances other than chromatopsia or disturbances of color vision may occur in elderly patients who have no other clinical manifestations of digitalis intoxication.

Digoxin-mediated inhibition of sodium-potassium ATPase influences normal uptake of extracellular potassium by Muller's cells and other retinal neurons and may result in decreased color vision.

Nervous system

Nervous system side effects reported in 25% of patients have included headache, dizziness, and weakness. At least one case of trigeminal neuralgia has been reported.

A 51-year-old man with ischemic cardiomyopathy complicated by congestive heart failure developed right trigeminal neuralgia associated with hyperalgesia between attacks. The pain resolved when digoxin was discontinued and reappeared upon rechallenge.

Psychiatric

Psychiatric side effects have included decreased cognition, memory, disorientation, emotional lability, and depression.

A 74-year-old man with supraventricular tachycardia developed altered cognition, memory, and depression with a serum digoxin level of 0.9 ng/mL. Symptoms resolved when digoxin levels decreased to 0.5 ng/mL.

Endocrine

Endocrine side effects have included increased (significant) serum estrogen, decreased serum luteinizing hormone, decreased (significant) serum testosterone, and gynecomastia.

A study of 38 patients (20 postmenopausal women) who had taken digoxin for at least two years, revealed significantly decreased serum luteinizing hormone and testosterone levels and significantly increased serum estrogen levels relative to a control group of men and postmenopausal women. The study did not control for underlying disease and it is possible that the sex hormone alterations were associated with the underlying diseases rather than use of digoxin.

Hypersensitivity

A 77-year-old man with congestive heart failure developed a psoriasiform rash associated with a positive macrophage inhibition factor test to digoxin. The rash resolved upon discontinuation of the drug and reappeared on rechallenge.

Hypersensitivity reactions have been reported rarely. At least one case of psoriasiform rash has been reported.

Hematologic

Hematologic side effects have been reported rarely. These have included thrombocytopenia.

A 60-year-old man with thyroid cancer and supraventricular tachycardia developed reversible thrombocytopenia during digoxin and heparin therapy. The thrombocytopenia resolved when digoxin alone was discontinued. The bone marrow examination and immunological studies were consistent with a digoxin-induced immune thrombocytopenia due to circulating immune complexes.

Metabolic

Three patients with Type II diabetes who experienced greater antidiabetic control and significant reduction in requirements of hypoglycemic agents following discontinuation of digoxin has been reported. Rechallenge in one patient resulted in increased glucose levels and subsequent dosage increases of hypoglycemic agents.

Metabolic side effects have included hypokalemia, hypomagnesemia, and hypercalcemia. Diabetes mellitus and glucose intolerance have been reported.

Dermatologic

Dermatologic side effects have been reported rarely. These have included maculopapular rash and other nonspecific skin reactions.

Other

Other side effects have been reported rarely. At least one case of diaphoresis and malaise has been reported. At least one case of digoxin cachexia, fatigue, weight loss, and decreased appetite has been reported.

A 48-year-old man with rheumatic mitral valve disease and atrial flutter/fibrillation developed profound diaphoresis and malaise associated with a serum digoxin level of 0.7 ng/mL. The symptoms resolved when digoxin was discontinued, and reappeared on rechallenge.

Cachexia, fatigue, and documented weight loss have been reported in rare cases. Appetites and weights improved after discontinuation of digoxin.

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