How do I report a medication side effect?
Last updated September 3, 2026.
First tell your prescriber or pharmacist, then file a report with FDA MedWatch. MedWatch is the FDA's safety reporting program, and it accepts reports directly from patients - online or by phone. You do not need to prove the drug caused the problem; the program exists to collect patterns, and your report is how rare dangers surface after approval.
What to do
- Talk to your prescriber first. They can tell whether it is a known side effect, a dose issue, or a reason to switch medications.
- Report serious reactions to MedWatch. Anything that hospitalized you, caused lasting harm, or was severe and unexpected belongs in the system.
- Gather the details before filing. Drug name and strength, start date, what happened and when, and your other medications.
- Do not assume someone else reported it. Reporting is voluntary, and many reactions go unlogged - yours may be the one that completes a pattern.
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