Label Changes for:
Cordarone (amiodarone HCl) 200 mg tablets
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
- pleural effusion
- (including eosinophilic pneumonia)” has been added to the pneumonitis listing
- There have been spontaneous reports of demyelinating polyneuropathy
- Eosinophilic pneumonia, pleural effusion, and demyelinating polyneuropathy
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.