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Cordarone

Last reviewed on RxList: 10/26/2018
Cordarone Side Effects Center

Last reviewed on RxList 10/26/2018

Cordarone (amiodarone) is an antiarrhythmic drug used for many serious arrhythmias of the heart including ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter. Cordarone is available in generic form. Common side effects of Cordarone include:

Tell your doctor if you have serious side effects of Cordarone including:
  • easy bruising or bleeding,
  • loss of coordination,
  • tingling or numbness of the hands or feet,
  • uncontrolled movements, or
  • new or worsening symptoms of heart failure (such as ankle or leg swelling, increased tiredness, increased shortness of breath when lying down).

Dosing varies depending on indication. Cordarone may interact with beta-blockers and certain calcium channel blockers resulting in an excessively slow heart rate or a block in the conduction of the electrical impulse through the heart. Cordarone increases the blood levels of digoxin, flecainide, phenytoin, and procainamide. Cordarone interacts with warfarin and increases the risk of bleeding. Amiodarone can interact with simvastatin, atorvastatin, and lovastatin, increasing the risk of severe muscle breakdown and kidney failure or liver disease. Cordarone is harmful to the fetus and to infants. It should not be administered during pregnancy and women should not breastfeed while taking Cordarone.

Our Cordarone 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.

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Cordarone Consumer Information

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

Amiodarone takes a long time to completely clear from your body. You may continue to have side effects from amiodarone after you stop using it.

Call your doctor at once if you have any of these side effects, even if they occur up to several months after you stop using amiodarone:

  • wheezing, cough, chest pain, cough with bloody mucus, fever;
  • a new or a worsening irregular heartbeat pattern (fast, slow, or pounding heartbeats);
  • a light-headed feeling, like you might pass out;
  • blurred vision, seeing halos around lights (your eyes may be more sensitive to light);
  • liver problems--nausea, vomiting, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
  • nerve problems--loss of coordination, muscle weakness, uncontrolled muscle movement, or a prickly feeling in your hands or lower legs;
  • signs of overactive thyroid--weight loss, thinning hair, feeling hot, increased sweating, tremors, feeling nervous or irritable, irregular menstrual periods, swelling in your neck (goiter); or
  • signs of underactive thyroid--weight gain, tiredness, depression, trouble concentrating, feeling cold.

Common side effects may include:

  • nausea, vomiting, loss of appetite; or
  • constipation.

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.

Read the entire detailed patient monograph for Cordarone (Amiodarone HCl Tablets)

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Cordarone Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in more detail in other sections of the prescribing information:

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 practice.

At the usual maintenance dose (400 mg/day) and above, CORDARONE causes adverse reactions in about three-fourths of all patients, resulting in discontinuation in 7 to 18%.

In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with CORDARONE, the adverse reactions most frequently requiring discontinuation of CORDARONE included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. Other symptoms causing discontinuations less often included visual disturbances, photosensitivity, blue skin discoloration, hyperthyroidism, and hypothyroidism.

The following side-effect rates are based on a retrospective study of 241 patients treated for 2 to 1,515 days (mean 441.3 days):

Thyroid

Common: Hypothyroidism, hyperthyroidism.

Cardiovascular

Common: Congestive heart failure, cardiac arrhythmias, SA node dysfunction.

Gastrointestinal

Very common: Nausea, vomiting.

Common: Constipation, anorexia, abdominal pain.

Dermatologic

Common: Solar dermatitis/photosensitivity.

Neurologic

Common: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias, decreased libido, insomnia, headache, sleep disturbances.

Ophthalmic

Common: Visual disturbances.

Hepatic

Common: Abnormal liver-function tests, nonspecific hepatic disorders.

Respiratory

Common: Pulmonary inflammation or fibrosis.

Other

Common: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities.

Uncommon: Blue skin discoloration, rash, spontaneous ecchymosis, alopecia, hypotension, and cardiac conduction abnormalities.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CORDARONE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic: hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma.

Immune: anaphylactic/anaphylactoid reaction (including shock), angioedema.

Neurologic: pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), demyelinating polyneuropathy.

Psychiatric: hallucination, confusional state, disorientation, delirium.

Cardiac: hypotension (sometimes fatal), sinus arrest.

Respiratory: eosinophilic pneumonia, acute respiratory distress syndrome in the post-operative setting, bronchospasm, bronchiolitis obliterans organizing pneumonia, pulmonary alveolar hemorrhage, pleural effusion, pleuritis.

Gastrointestinal: pancreatitis, acute pancreatitis.

Hepatic: hepatitis, cholestatic hepatitis, cirrhosis.

Skin and Subcutaneous Tissue Disorders: urticaria, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, pruritus, skin cancer, lupus-like syndrome.

Musculoskeletal: myopathy, muscle weakness, rhabdomyolysis.

Renal: renal impairment, renal insufficiency, acute renal failure.

Reproductive: epididymitis, impotence.

Body as a whole: fever, dry mouth.

Endocrine and metabolic: thyroid nodules/ thyroid cancer, syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Vascular: vasculitis.

Read the entire FDA prescribing information for Cordarone (Amiodarone HCl Tablets)

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Related Resources for Cordarone

Read the Cordarone User Reviews »

© Cordarone Patient Information is supplied by Cerner Multum, Inc. and Cordarone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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