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Lanoxin

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Lanoxin Injection

Lanoxin Side Effects Center

Medical Author: Melissa Conrad Stöppler, MD

Lanoxin (digoxin) is a drug used to enhance the strength of the heartbeat and improve heart beat regularity. It is available in generic form and is used to treat a number of different heart problems. Common side effects can include mild nausea, vomiting, or diarrhea; feeling weak or dizzy; or headache. This is not a complete list of side effects, and others may occur.

Lanoxin is available in tablet as well as injection form. Many different drugs can potentially interact with Lanoxin; alprazolam (Xanax), clonidine (Catapres), spironolactone (Aldactone, Aldactazide), and some antibiotics are a few examples. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman, so digoxin should be given to a pregnant woman only if clearly needed. Studies have shown that digoxin concentrations in the mother's serum and milk are similar, but the estimated exposure of a nursing infant to digoxin via breastfeeding will be far below the usual infant maintenance dose. Therefore, there should be no pharmacologic effect upon the infant. Before using digoxin, tell your doctor if you have certain heart conditions, especially "AV block" (unless you have a pacemaker) or a recent history of heart attack. Do not stop taking digoxin without first talking to your doctor because doing so may worsen your condition.

Our Lanoxin 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 Prescribing information?

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

Lanoxin 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 5-20%, 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.

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 (Digoxin Injection) »

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Additional Lanoxin Injection Information

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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