Black Box Warning

Amiodarone can cause serious lung problems (including pneumonitis, pulmonary fibrosis, and acute respiratory distress syndrome (ARDS)), which can be fatal. Liver problems, including liver failure requiring transplantation, have been reported. Amiodarone can worsen arrhythmias (proarrhythmic effect), sometimes resulting in death. Because of the risk of these serious adverse reactions, reserve amiodarone for patients with recurrent life-threatening ventricular fibrillation or recurrent hemodynamically unstable ventricular tachycardia that is not adequately responsive to other antiarrhythmic therapy or when alternative agents cannot be tolerated.