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Label Changes for:

Flagyl (metronidazole) tablets, capsules, and Flagyl ER tablets

August 2010

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

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

 

WARNINGS

Central and Peripheral Nervous System Effects
  • encephalopathy, aseptic meningitis, optic neuropathy have been reported in patients treated with metronidazole

ADVERSE REACTIONS

The most serious adverse reactions reported in patients treated with Flagyl (metronidazole) have been... encephalopathy, aseptic meningitis, optic neuropathy

Central Nervous System
  • Encephalopathy, aseptic meningitis, optic neuropathy, dysarthria
Hypersensitivity
  • Stevens-Johnson Syndrome, toxic epidermal necrolysis,
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