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U.S. Department of Health and Human Services

Safety

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Factive (gemifloxacin mesylate) Tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

 

Summary View

 

WARNINGS

Central Nervous System Effects/ Disorders
  • ... Although not seen in Factive clinical trials, convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving other fluoroquinolones.”