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U.S. Department of Health and Human Services

Safety

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Zithromax (azithromycin) for Oral Suspension, Tablet, Single Dose Packet, and for Injection (IV infusion) and Zmax (azithromycin extended release) for Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013

Summary View

 

WARNINGS

QT Prolongation
  • Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
    • patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
    • patients on drugs known to prolong the QT interval
    • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or…