Filing a MedWatch Report

The FDA encourages patients to take the Reporting Form to their treating doctor when it is known or suspected that they have been seriously harmed by a pharmaceutical product. However, it is important to understand that this physician is not required to make a report to the FDA, even if you ask them to do so.

For this reason, and because there may be circumstances when a person does not want to go back to their doctor to ask for help with a drug injury report, patients can submit their information directly to the FDA. There is an online reporting form available through the FDA web site. You can reach the FDA web site by clicking here. You will then need to click the online reporting form link on that page. If you wish to download and print a pdf format version of the form, click here. Thereafter, the completed form can be faxed or mailed to FDA as instructed on the form. Lastly, you can use the toll-free telephone number for reporting a suspected drug injury to the FDA: 800-FDA-1088.

Be assured that the patient's identity will be held in strict confidence by the FDA. In addition, the FDA will not disclose to the identity of the person who submitted the report, be it the doctor, the patient, a family member, a health care provider, or some other concerned person.

Information provided to the FDA through the MedWatch system is included in the FDA Adverse Event Reporting System (AERS).