How to Report Problems with Medical Products to the FDA

Updated September 2010

Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects – also called adverse reactions – can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You do not have to be certain that the health problem is caused by the medical product – the purpose of a tracking program is to figure out if there is a problem by looking for a pattern in the reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online or you or your doctor can request a copy of the form by calling the FDA toll free at 1-888-INFO-FDA (1-888-463-6332).

If for some reason you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (doctors are not required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, as well as an online form that you can submit on the website.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have questions or comments about a specific drug or medical device, you can call the FDA toll free information number at 1-888-INFO-FDA (1-888-463-6332), press 2, followed by 1 for information, then:

  • for dietary supplements, press 2
  • for drug products, press 3
  • for medical devices, press 4
  • for biologics, including human cells, tissues and cellular and tissue-based products, press 6

Reporting problems helps fix them and ensure that other patients do not experience the same unexpected side effects or reactions.