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 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program

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Reporting Adverse Experiences to FDA

Adverse Reactions - Product Quality Problems - Product Use Errors

Voluntary Reporting

Report serious adverse events online for human medical products, including potential and actual product use errors, product quality problems, and therapeutic inequivalence/failure. The introductory page features additional information and instructions.

Mandatory Reporting

Access to FDA Safety Data

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