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U.S. Department of Health and Human Services

Safety

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Factive (gemifloxacin mesylate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified
Factive (gemifloxacin mesylate) Tablets

MEDICATION GUIDE

 

“new safety information” with the use of Factive, particularly the increased risks of tendonitis and tendon rupture.

  • What is the most important information I should know about Factive?
    • Tendon rupture or swelling of the tendon (tendinitis)
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