Got Side Effects From Drugs? Report Them To the FDA

Over the past few years, the numbers of recalled pharmaceuticals has grown as new drugs are rushed to market before their safety is proven. Want to help improve drug safety? If you experience any serious side-effects from pharmaceutical or suspect drug interactions be sure to report these instances to the FDA. Here’s how:

Download this form.

The FDA strongly recommends that you ask your health care provider to fill it out because he or she can “provide clinical information based on your medical record that can help” the FDA evaluate your report. If you can’t or don’t want to give the form to your doctor, you can fill it out yourself.

Either fax the form to the FDA at 1-800-FDA-0178 or mail it back using the postage-paid addressed form.


Call FDA at 1-800-FDA-1088 to report by telephone

The FDA, via a program called MedWatch, also collects data on other drug problems. You should report these as well. Here is what MedWatch is concerned with:

1) Serious adverse event
* death
* life-threatening situation
* requires admission to hospital or longer-than-expected hospital stay
* permanent disability
* birth defect, miscarriage, stillbirth, or birth with serious disease
* requires medical care to prevent permanent damage

2. Product quality problem
* suspected counterfeit product
* potentially contaminated product indicated by suspicious odor or unusual color
* inaccurate or unreadable product labeling

3) Product use error
* mixing up products with similar drug names or packaging
* taking wrong dose of a drug because of confusing dosing instructions on label

4) Problem with different manufacturer of same medicine
* not getting same results from a generic drug as a brand name drug, or from another generic

Reporting by Consumers [FDA]
FDA 101: How to Use the Consumer Complaint System and MedWatch [FDA]

(Photo: Mike Burns)

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