Anyone in the U.S. can report a suspected side effect through FDA MedWatch. Here’s what you need to know.
If the reaction is severe, life-threatening, or worsening — get emergency care first. Everything else can wait.
Online — Start a voluntary report on the FDA MedWatch site
Phone — Call 1-800-FDA-1088 for help choosing the right reporting path
Fax / mail — Use Form FDA 3500B and fax to 1-800-FDA-0178
Product name and strength
What happened and which symptoms you noticed
When it started and any relevant dose timing
Whether the product was stopped, restarted, or changed
Outcome so far, including any treatment or hospitalization
Other medicines or supplements used at the same time
The FDA reviews reports to detect safety patterns that clinical trials may have missed. Your report can contribute to label changes, safety alerts, or recalls.
This is not medical advice. OpenClaim helps you research — your doctor helps you decide.