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Reporting of Serious Adverse Events After Antiviral Medications Severe adverse events associated with the administration of antiviral medications used to prevent or treat influenza (e.g., those resulting in hospitalization or death) should be reported to MedWatch, FDA's Safety Information and Adverse Event Reporting Program, at telephone 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, or via the Internet by sending Report Form 3500 (available at http://www.fda.gov/medwatch/safety/3500.pdf). Instructions regarding the types of adverse events that should be reported are included on MedWatch report forms. |