What it means
Anyone can submit a MedWatch report, not only doctors. Reports can cover a suspected side effect, a medication error, a product quality problem such as a faulty pen, or a concern about a counterfeit or compounded product.
Reports go online through the FDA's MedWatch site. Vaccines, tobacco products and animal products use separate reporting systems.
A single report does not prove a drug caused a problem. The FDA looks for patterns across many reports, along with trial data and other studies. That process can lead to label changes, new warnings or safety communications.
When you report, include the product name, strength, lot number if you have it, dates, what happened and how it turned out. Telling your prescriber is still the first step, since they can assess what happened and decide what to do next. Many drug makers also accept reports through their own safety lines.
Why it matters
MedWatch reports help the FDA spot rare GLP-1 problems that trials were too small to find.