FDA MedWatch
Report adverse events from drugs, biologics, devices, vaccines, and cosmetics. Useful for documenting drug-related insurance disputes.
What this agency handles
Adverse event reporting for prescription drugs, OTC drugs, biologics, medical devices, vaccines (via VAERS for vaccines), dietary supplements, cosmetics. Also drug-recall information.
When to file
When you've experienced an adverse event from a medication or device. Useful supporting documentation for insurance appeals involving the same drug/device.
How to file
MedWatch.fda.gov online (Form FDA 3500) or 1-800-FDA-1088.
Frequently asked questions
What does FDA MedWatch handle?
Adverse event reporting for prescription drugs, OTC drugs, biologics, medical devices, vaccines (via VAERS for vaccines), dietary supplements, cosmetics. Also drug-recall information.
When should I file with them?
When you've experienced an adverse event from a medication or device. Useful supporting documentation for insurance appeals involving the same drug/device.
How do I file?
MedWatch.fda.gov online (Form FDA 3500) or 1-800-FDA-1088.
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