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U.S. Department of Health and Human Services

Safety

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Avelox (moxifloxacin) tablets and I.V.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

 

Summary View

 

(data numbers updated)

WARNINGS

QT prolongation
  • ...QTc prolongation occurred with moxifloxacin treatment in over 15,500 patients in controlled clinical studies, including 759...

ADVERSE REACTIONS

  • Clinical efficacy trials enrolled over 15,500 moxifloxacin orally and intravenously treated patients, of whom over 14,900 patients received the 400 mg dose.