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Cordarone

Last reviewed on RxList: 4/24/2017
Cordarone Side Effects Center

Last reviewed on RxList 04/21/2017

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:

  • Nausea
  • Vomiting
  • Constipation
  • Weight loss
  • Fatigue
  • Pulmonary fibrosis
  • Heart block
  • Heart failure
  • Dizziness
  • Tiredness
  • Shaking or tremor
  • Numbness and tingling
  • Stomach pain
  • Loss of appetite
  • Sleep problems (insomnia)
  • Weakness
  • Lack of coordination
  • Warmth, tingling, or redness under your skin
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.

Cordarone Consumer Information

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 any of these serious side effects, even if they occur up to several months after you stop using amiodarone:

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • feeling like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up blood;
  • blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
  • feeling short of breath, even with mild exertion, swelling, rapid weight gain;
  • weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
  • numbness, burning, pain, or tingling in your hands or feet; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • feeling dizzy or tired;
  • nausea, vomiting, stomach pain, constipation, loss of appetite;
  • sleep problems (insomnia);
  • weakness, lack of coordination; or
  • warmth, tingling, or redness under your skin.

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)

Cordarone Professional Information

SIDE EFFECTS

Adverse reactions have been very common in virtually all series of patients treated with Cordarone for ventricular arrhythmias with relatively large doses of drug (400 mg/day and above), occurring in about three-fourths of all patients and causing discontinuation in 7 to 18%. The most serious reactions are pulmonary toxicity, exacerbation of arrhythmia, and rare serious liver injury (see WARNINGS), but other adverse effects constitute important problems. They are often reversible with dose reduction or cessation of Cordarone treatment. Most of the adverse effects appear to become more frequent with continued treatment beyond six months, although rates appear to remain relatively constant beyond one year. The time and dose relationships of adverse effects are under continued study.

Neurologic problems are extremely common, occurring in 20 to 40% of patients and including malaise and fatigue, tremor and involuntary movements, poor coordination and gait, and peripheral neuropathy; they are rarely a reason to stop therapy and may respond to dose reductions or discontinuation (see PRECAUTIONS). There have been spontaneous reports of demyelinating polyneuropathy.

Gastrointestinal complaints, most commonly nausea, vomiting, constipation, and anorexia, occur in about 25% of patients but rarely require discontinuation of drug. These commonly occur during high-dose administration (i.e., loading dose) and usually respond to dose reduction or divided doses.

Ophthalmic abnormalities including optic neuropathy and/or optic neuritis, in some cases progressing to permanent blindness, papilledema, corneal degeneration, photosensitivity, eye discomfort, scotoma, lens opacities, and macular degeneration have been reported. (See WARNINGS.)

Asymptomatic corneal microdeposits are present in virtually all adult patients who have been on drug for more than 6 months. Some patients develop eye symptoms of halos, photophobia, and dry eyes. Vision is rarely affected and drug discontinuation is rarely needed.

Dermatological adverse reactions occur in about 15% of patients, with photosensitivity being most common (about 10%). Sunscreen and protection from sun exposure may be helpful, and drug discontinuation is not usually necessary. Prolonged exposure to Cordarone occasionally results in a blue-gray pigmentation. This is slowly and occasionally incompletely reversible on discontinuation of drug but is of cosmetic importance only.

Cardiovascular adverse reactions, other than exacerbation of the arrhythmias, include the uncommon occurrence of congestive heart failure (3%) and bradycardia. Bradycardia usually responds to dosage reduction but may require a pacemaker for control. CHF rarely requires drug discontinuation. Cardiac conduction abnormalities occur infrequently and are reversible on discontinuation of drug.

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).

The following side effects were each reported in 10 to 33% of patients:

Gastrointestinal: Nausea and vomiting.

The following side effects were each reported in 4 to 9% of patients:

Dermatologic: Solar dermatitis/photosensitivity.

Neurologic: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias.

Gastrointestinal: Constipation, anorexia.

Ophthalmologic: Visual disturbances.

Hepatic: Abnormal liver-function tests.

Respiratory: Pulmonary inflammation or fibrosis.

The following side effects were each reported in 1 to 3% of patients:

Thyroid: Hypothyroidism, hyperthyroidism.

Neurologic: Decreased libido, insomnia, headache, sleep disturbances.

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

Gastrointestinal: Abdominal pain.

Hepatic: Nonspecific hepatic disorders.

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

The following side effects were each reported in less than 1% of patients:

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

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, solar dermatitis, blue skin discoloration, hyperthyroidism, and hypothyroidism.

Postmarketing Reports

In postmarketing surveillance, serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with ledipasvir/sofosbuvir or with sofosbuvir with simeprevir, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, urticaria, eosinophilic pneumonia, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, acute pancreatitis, renal impairment, renal insufficiency, acute renal failure, acute respiratory distress syndrome in the post-operative setting, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pulmonary alveolar hemorrhage, pleural effusion, pleuritis, pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, demyelinating polyneuropathy, hallucination, confusional state, disorientation, delirium, epididymitis, impotence, dry mouth, and lupus-like syndrome, also have been reported with amiodarone therapy.

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

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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