Imagine that you’re taking a medication or using a medical device to treat a sleep disorder. Then something bad happens:  The treatment fails to work, or you end up in the hospital. You talk to your medical provider about your treatment options. But what else should you do?

You should tell the Food and Drug Administration about your experience. An FDA program called MedWatch helps identify important safety concerns to protect you from unexpected problems that could be dangerous.

How does MedWatch work?

The FDA regulates a wide range of products — everything from drugs and medical devices to cosmetics and infant formula. MedWatch allows patients, consumers, and health care providers to report serious problems with the medical products they use or prescribe.

Reporting problems with drugs or medical devices can help the FDA detect safety hazards. If a safety hazard is found, the FDA can issue a safety alert or recall.

The FDA gets important information when you submit a report to MedWatch about unexpected side effects, adverse events, or other problems. Learn more about the type of reports the FDA needs from you.

This video describes what you should know about submitting a MedWatch report.

 

You’re encouraged to report adverse events, side effects, or other problems related to FDA-regulated products to the FDA at www.fda.gov/medwatch.

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Authored by:

Kate Robards