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Cordarone IV

Last reviewed on RxList: 3/4/2021
Cordarone IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cordarone IV?

Cordarone IV (amiodarone hydrochloride) Intravenous is an antiarrhythmic drug used to treat and prevent frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Cordarone I.V. also can be used to treat patients with VT/VF for whom oral Cordarone is indicated, but who are unable to take oral medication. The brand name Cordarone IV is discontinued, but generic versions may be available.

What Are Side Effects of Cordarone IV?

Common side effects of Cordarone IV (amiodarone hydrochloride) include:

Dosage for Cordarone IV

The recommended starting dose of Cordarone I.V. is about 1000 mg over the first 24 hours of therapy.

What Drugs, Substances, or Supplements Interact with Cordarone IV?

Cordarone IV may interact with protease inhibitors, loratadine, cimetidine, antidepressants, grapefruit juice, cyclosporine, simvastatin, digoxin, other antiarrhythmic drugs, beta-blockers, calcium channel antagonists, anticoagulants, clopidogrel, antibiotics, St. Johns Wort, fentanyl, lidocaine, dextromethorphan, cholestyramine, disopyramide, azole antifungals, propranolol, diltiazem, verapamil, phenytoin, dextromethorphan, methotrexate, and diuretics. Tell your doctor all medications and supplements you use.

Cordarone IV During Pregnancy and Breastfeeding

Cordarone IV may be harmful to a fetus if administered during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant before using Cordarone IV. This drug passes into breast milk. Breastfeeding while using this drug is not recommended.

Additional Information

Our Cordarone IV (amiodarone hydrochloride) Intravenous 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 IV 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. It could take up to several months for the medicine to completely clear from your body.

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:

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • a light-headed feeling, like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up blood;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
  • swelling, pain, redness, or irritation around your IV needle;
  • weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
  • pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • little or no urinating.

Common side effects may include:

  • low fever;
  • slight dizziness; or
  • mild nausea, vomiting.

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 IV (Amiodarone Intravenous)

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Cordarone IV Professional Information

SIDE EFFECTS

In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received Cordarone I.V. for at least 1 week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days.

The most important treatment-emergent adverse effects were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Overall, treatment was discontinued for about 9% of the patients because of adverse effects. The most common adverse effects leading to discontinuation of Cordarone I.V. therapy were hypotension (1.6%), asystole/cardiac arrest/EMD (1.2%), VT (1.1%), and cardiogenic shock (1%).

The following table lists the most common (incidence 2%) treatment-emergent adverse events during Cordarone I.V. therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse events appeared to be dose-related.

SUMMARY TABULATION OF TREATMENT-EMERGENT DRUG-RELATED STUDY EVENTS IN PATIENTS RECEIVING CORDARONE I.V. IN CONTROLLED AND OPEN-LABEL STUDIES (≥ 2% INCIDENCE)

Study Event
Controlled Studies (n=814)
Open-Label Studies (n=1022)
Total (n=1836)
Body as a Whole
Fever
24 (2.9%)
13 (1.2%)
37 (2.0%)
Cardiovascular System
Bradycardia
49 (6.0%)
41 (4.0%)
90 (4.9%)
Congestive heart failure
18 (2.2%)
21 (2.0%)
39 (2.1%)
Heart arrest
29 (3.5%)
26 (2.5%)
55 (2.9%)
Hypotension
165 (20.2%)
123 (12.0%)
288 (15.6%)
Ventricular tachycardia
15 (1.8%)
30 (2.9%)
45 (2.4%)
Digestive System
Liver function tests abnormal
35 (4.2%)
29 (2.8%)
64 (3.4%)
Nausea
29 (3.5%)
43 (4.2%)
72 (3.9%)

Other treatment-emergent possibly drug-related adverse events reported in less than 2% of patients receiving Cordarone I.V. in Wyeth-Ayerst controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting.

Postmarketing Reports

In postmarketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, renal impairment, renal insufficiency, acute renal failure, 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, pleuritis, pseudotumor cerebri, syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, hallucination, confusional state, disorientation, delirium, epididymitis, and impotence also have been reported with amiodarone therapy.

Also, in patients receiving recommended dosages of Cordarone I.V., there have been postmarketing reports of the following injection site reactions: pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing (see DOSAGE AND ADMINISTRATION).

Read the entire FDA prescribing information for Cordarone IV (Amiodarone Intravenous)

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

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