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U.S. Department of Health and Human Services

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Adverse Event Reports

View PDF of the Adverse Event Reports Section (72 KB)


Background

Summary of Public Comments

Considerations

Transparency Report Arrow View All Adverse Event Reports Draft Proposals


Draft Proposals

Draft Proposal 1

FDA should expand the areas in which it provides the public with online access to public information from adverse event reports about FDA-regulated products submitted to FDA, in a format that is searchable and allows users to generate summary reports of this information, including, if known and as applicable, the trade name and/or established name of the product, dosage, route of administration, description of the adverse event, and the health outcome.  Adverse event report information should continue to be disclosed with a clear disclaimer about the limits of the information.