Label Changes for:

Cordarone (amiodarone HCl) 200 mg tablets

September 2009

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) -- September 2009

WARNINGS

Pulmonary Toxicity
  • pleural effusion
  • (including eosinophilic pneumonia)” has been added to the pneumonitis listing

ADVERSE REACTIONS

  • There have been spontaneous reports of demyelinating polyneuropathy
Postmarketing Reports
  • Eosinophilic pneumonia, pleural effusion, and demyelinating polyneuropathy

MEDICATION GUIDE

  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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