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Label Changes for:

Avelox (moxifloxacin HCl) Tablets

February 2008

Changes have been made to the PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008


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.

Summary View

Sections Modified


  • Moderate to severe photosensitivity/phototoxicity reactions...
  • Information for Patients
    • Photosensitivity/Phototoxicity has been reported...


  • Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of moxifloxacin treated patients were...
    • photosensitivity/phototoxicity reactions...
  • Postmarketing Adverse Event Reports
    • Photosensitivity/Phototoxicity Reaction...


  • What are possible side effects of Avelox?
    • Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet light (UV) (e.g. tanning beds). Avelox has been infrequently associated with photosensitivity...