Objectives-Amiodarone is a commonly used anti-arrhythmic drug. Hepatotoxicity following chronic oral administration occurs in 1% to 3% of patients. Hepatotoxicity following intravenous (IV) administration is infrequent but may be associated with dramatic increases in serum transaminases. We describe the incidence of liver toxicity among patients receiving IV amiodarone during a 5-year period.Methods-This was a single-center retrospective review of patients receiving IV amiodarone for any cause. The outcome measures were development of elevated serum transaminases and the relation of transaminitis to all-cause 30-day mortality.Results-A total of 1510 patients received amiodarone intravenously between 2005 and 2011; 77 (5%) developed elevated liver enzymes. Enzyme elevation was divided into mild (100-300 IU/L), moderate (300-1000 IU/L), and severe (>1000 IU/L). The median alanine aminotransferase was 189 (37-10,006) IU/L and aspartate aminotransferase was 253 (84-12,005) IU/L. The 30-day mortality among those with transaminitis was 22%; however, no patient died of amiodaronerelated liver disease.Conclusions-Amiodarone can cause severe elevation in liver enzymes. The incidence of severe transaminitis is low; deaths following IV amiodarone are rarely caused by drug-induced liver failure. Keywordsamiodarone; intravenous; hepatotoxicity; arrhythmia; atrial fibrillation; mortality; polysorbate 80Amiodarone is a class III antiarrhythmic drug used to treat atrial and ventricular arrhythmias. 1,2 Its adverse effects involve many organ systems and result in cessation of the medication in 10% to 15% of patients. Common adverse effects of oral amiodarone include thyroid dysfunction, corneal microdeposits, hepatic dysfunction, and pulmonary fibrosis, 3,4 and asymptomatic elevations in liver enzymes are reported in 15% to 50% of long-term users. 5,6 Symptomatic liver injury is rare but potentially fatal, occurring in 1% to 3 % of long-term users. [7][8][9][10] Amiodarone often is given by intravenous (IV) bolus in the management of potentially lifethreatening arrhythmias. Adverse effects following IV amiodarone administration include injection site reactions, diaphoresis, flushing, sinus bradycardia, atrioventricular block, and hypotension. 3,4 Acute amiodarone hepatotoxicity also may follow intravenous amiodarone. 7 The presentation of acute hepatotoxicity varies from mild asymptomatic increases in serum transaminases (transaminitis) to fulminant hepatic failure. The clinical presentations, incidence, and outcomes are less well described. The aim of this study was to determine the incidence, prevalence, and clinical manifestations of acute hepatitis following the IV administration of amiodarone. We retrospectively reviewed the clinical data from patients receiving IV amiodarone therapy at the Michael E. DeBakey Veterans Affairs Medical Center between July 2005 and July 2011. We also assessed potentially important variables possibly predicting the presence, severity, and outcome of acute hepatic injury. HHS Public A...