FDA MedWatch Program

Reporting Adverse Drug Reactions

MedWatch is an FDA program for reporting "serious reactions" resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:

• Patient's Death: when adverse reaction to drug is the suspected cause of death
• Life-Threatening Condition: serious side-effect put patient at real risk of dying
• Hospitalization: admitted because of serious adverse reaction to medication
• Permanent Disability: strokes; nervous system disorders; other impairment
• Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to child
• Needs Medical Intervention to Avoid Permanent Damage: medical treatment required

There are several different ways to file a MedWatch report with the FDA. We provide some basic information about how to file a MedWatch report on this site.

If you are interested in getting the facts of your possible drug injury claim reviewed by our law firm, click here for a free legal case evaluation.