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Lanoxin Tablets

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Lanoxin

Lanoxin

Lanoxin Tablets Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Lanoxin Tablets (digoxin) is a member of the cardiac glycoside group of drugs that have specific effects on the myocardial (heart muscle) tissue. Lanoxin is available in a generic form termed digoxin. Lanoxin is used to treat heart failure by increasing left ventricular ejection fractions and arrhythmias such as atrial fibrillation by controlling the ventricular response rate. Most side effects and toxicity of Lanoxin Tablets are avoided if the maintenance dose (see below) is within prescribed limits.

Lanoxin Tablets are supplied as 125 or 250 mcg (microgram) once a day; adequate dosing without toxicity is determined usually by a blood test that determines the drug's level in the blood. Side effects and toxic effects of Lanoxin Tablets differ mainly in severity; symptoms are blurry or yellowish vision, anorexia, nausea, vomiting, and mental changes. More serious events such as cardiac PR interval prolongation, ST depression, heart block, ventricular tachycardia or ventricular fibrillation may occur. In children, sometimes the initial symptoms are cardiac arrhythmias such as bradycardia or tachycardias. There are no controlled studies of Lanoxin Tablets in pregnancy, although there are a few reports of its successful use. A few studies suggest only a small amount of Lanoxin reaches breast milk; currently, most investigators suggest that the benefits of drug use should outweigh the potential problems before Lanoxin is used in pregnant or lactating females.

Our Lanoxin Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lanoxin Tablets in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast, slow, or uneven heart rate;
  • bloody or black, tarry stools;
  • blurred vision, yellowed vision; or
  • confusion, hallucinations, unusual thoughts or behavior.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea;
  • feeling weak or dizzy;
  • headache;
  • enlarged breasts in men; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lanoxin Tablets (Digoxin Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lanoxin Tablets FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are included in more detail in the WARNINGS AND PRECAUTIONS section of the label:

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 LANOXIN are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect. Hence, adverse reactions are less common when LANOXIN 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.

In the DIG trial (a trial investigating the effect of digoxin on mortality and morbidity in patients with heart failure), the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking LANOXIN compared to 0.9% in patients taking placebo [see Clinical Studies].

The overall incidence of adverse reactions with digoxin has been reported as 5 to 20%, with 15 to 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.

Gastrointestinal: In addition to nausea and vomiting, the use of digoxin has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.

CNS: Digoxin can cause headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).

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

Read the entire FDA prescribing information for Lanoxin Tablets (Digoxin Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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