FDA MedWatch Alerts


Whenever you think a medical product may be associated with a serious event (seizure, bronchospasm, GI bleed, hospitalization, life-threatening illness, disability, congenital anomaly, etc.) You need not be sure about causality; if you suspect the product is associated with a serious event, FDA is interested.


Reporting is easier than you think. Although the form asks for many details, the only required info is the product and a description of the problem.


Your report might be the vital action that prompts a change in drug design, identifies unsuspected drug toxicity, or leads to safer use for patients.


Anyone can report a serious adverse event that may be associated with a medical product or device.


It takes only minutes. There are 4 ways to report: secure online forms available at the links to the right; one-page fax or mail form, or phone 1-800-FDA-1088.


FDA has created a safe environment for sharing patient data for public health surveillance. HIPAA allows for reporting of adverse events to FDA without patient authorization. No follow-up from FDA or manufacturers is required; reporting is not an admission of fault.

Epocrates Resources: Our FDA Reporting quick reference list is available in our premium mobile and online products.

Get the latest FDA alerts on your device

The Epocrates DocAlert® message service is continually updated with the latest FDA MedWatch Alerts in your specialty. Refine your specialty under My Account.

Select a platform for details on regular updating. Don't have Epocrates? Get it now.