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Does Cordarone (amiodarone) cause side effects?
Cordarone is considered a “broad spectrum” antiarrhythmic medication, that is, it has multiple and complex effects on the electrical activity of the heart which is responsible for the heart's rhythm.
In addition to being an antiarrhythmic medication, Cordarone also causes blood vessels to dilate (enlarge). This effect can result in a lowering of blood pressure. Because of this effect, Cordarone also may be of benefit in patients with congestive heart failure.
Common side effects of Cordarone include:
- eye deposits,
- unsteady gait,
- weight loss,
- dizziness, and
- visual changes.
Serious side effects of Cordarone include:
- heart block,
- low blood pressure,
- scarring of the lungs (pulmonary fibrosis),
- heart failure,
- cardiac arrest,
- hypothyroidism or hyperthyroidism,
- blue skin discoloration,
- liver failure, and
- cardiogenic shock.
Blood levels of are increased when these drugs are combined with Cordarone:
These can inhibit the enzyme that is responsible for the metabolism of Cordarone in the body:
Tricyclic antidepressants and phenothiazines can potentially cause serious arrhythmias when combined with Cordarone.
Warfarin when taken with Cordarone increases the risk of bleeding.
Cordarone inhibits the metabolism of dextromethorphan.
Grapefruit juice may reduce the breakdown of a Cordarone in the stomach leading to increased amiodarone blood levels.
What are the important side effects of Cordarone (amiodarone)?
- Cordarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
- Cordarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time.
- Liver injury is common with Cordarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases.
- Like other antiarrhythmics, Cordarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse.
- This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%.
- All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with Cordarone than with many other agents used in this population, the effects are prolonged when they occur.
- Even in patients at high risk of arrhythmic death, in whom the toxicity of Cordarone is an acceptable risk, Cordarone poses major management problems that could be lifethreatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.
- The difficulty of using Cordarone effectively and safely itself poses a significant risk to patients.
- Patients with the indicated arrhythmias must be hospitalized while the loading dose of Cordarone is given, and a response generally requires at least one week, usually two or more.
- Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment.
Common side effects
Common side effects include:
- eye deposits,
- unsteady gait,
- weight loss,
- dizziness, and
- visual changes.
Amiodarone is also associated with:
Cordarone (amiodarone) side effects list for healthcare professionals
The following serious adverse reactions are described in more detail in other sections of the prescribing information:
- Pulmonary Toxicity
- Hepatic Injury
- Worsened Arrhythmia
- Visual Impairment and Loss of Vision
- Thyroid Abnormalities
- Peripheral Neuropathy
- Photosensitivity and Skin Discoloration
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,
- blue skin discoloration,
- hyperthyroidism, and
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):
Common: Hypothyroidism, hyperthyroidism.
Common: Congestive heart failure, cardiac arrhythmias, SA node dysfunction.
Very common: Nausea, vomiting.
Common: Solar dermatitis/photosensitivity.
Common: Visual disturbances.
Common: Abnormal liver-function tests, nonspecific hepatic disorders.
Common: Pulmonary inflammation or fibrosis.
Common: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities.
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.
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.
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.
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.
Renal: renal impairment, renal insufficiency, acute renal failure.
Reproductive: epididymitis, impotence.
What drugs interact with Cordarone (amiodarone)?
Because of amiodarone's long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone.
Drug interactions with amiodarone are described in Table 1 below.
Table 1: Amiodarone Drug Interactions
|Concomitant Drug Class/Name||Examples||Clinical Comment|
|QT Prolonging Drugs||class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents||Increased risk of Torsade de Pointes. Avoid concomitant use.|
|Negative Chronotropes||digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine||Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate.|
|CYP450 Inhibitors||grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors||Increased exposure of amiodarone. Avoid concomitant use.|
|CYP450 Inducers||St. John’s Wort||Reduced amiodarone serum levels.|
|Cyclosporine||Increased plasma levels of cyclosporine have been reported resulting in elevated creatinine, despite reduction of cyclosporine dose. Monitor cyclosporine drug levels and renal function with concomitant use.|
|Cholestyramine||Reduced amiodarone serum levels.|
|Antiarrhythmics||quinidine, procainamide, flecainide||Reserve concomitant use for patients who are unresponsive to a single agent. Antiarrhythmic metabolism inhibited by amiodarone. Initiate antiarrhythmic at a lower than usual dose and monitor patient carefully. Reduce dose levels of previously administered antiarrhythmic by 30 to 50% for several days after transitioning to oral amiodarone. Evaluate continued need for antiarrhythmic.|
|Digoxin||Increased digoxin concentration. Reduce digoxin by half or discontinue. If continued, monitor for evidence of toxicity.|
|HMG-CoA Reductase Inhibitors||simvastatin, lovastatin, atorvastatin||Increased plasma concentration of HMG-CoA reductase inhibitor. Limit the dose of lovastatin to 40 mg. Limit the coadministered dose of simvastatin to 20 mg. Lower starting dose of other CYP3A4 substrates may be required.|
|Warfarin||Potentiates anticoagulant response and can result in serious or fatal bleeding. Coadministration increases prothrombin time by 100% after 3 to 4 days. Reduce warfarin dose by one-third to one-half and monitor prothrombin times.|
|Phenytoin||Increased steady-state levels of phenytoin. Monitor phenytoin levels.|
|Hepatitis C Direct Acting Antiviral||sofosbuvir||Cases of symptomatic bradyarrhythmia requiring pacemaker insertion have been reported in patients on oral maintenance amiodarone who initiated therapy with sofosbuvir.|
|CYP3A Substrate||lidocaine||Sinus bradycardia has been reported with oral amiodarone in combination with lidocaine given for local anesthesia. Monitor heart rate. A lower starting dose of lidocaine may be required.|
|CYP3A Substrate||fentanyl||Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output.|
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Heart disease (coronary artery disease) occurs when plaque builds up in the coronary arteries, the vessels that supply blood to the heart. Heart disease can lead to heart attack. Risk factors for heart disease include: Smoking High blood pressure High cholesterol Diabetes Family history Obesity Angina, shortness of breath, and sweating are just a few symptoms that may indicate a heart attack. Treatment of heart disease involves control of heart disease risk factors through lifestyle changes, medications, and/or stenting or bypass surgery. Heart disease can be prevented by controlling heart disease risk factors.
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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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.