The only way that information on rare, unusual or long-term side effects of drugs can be gathered is if health care providers report information about such side effects to the Food and Drug Administration (FDA). To try to capture information on the rate of serious side effects associated with drugs, the FDA has a system in place called MedWatch. The success of the MedWatch system, however, is entirely dependent on physicians or other health care providers filling out the MedWatch form and sending it to the FDA. In cases where a doctor or health care provider is too busy to fill out the paperwork, or other circumstances prevent a doctor from doing so (e.g. you don't want the event reported by your doctor), you may file a report yourself.
Your doctor can obtain the MedWatch Voluntary Reporting Form by calling the MedWatch office at 1-800-332-1088. The one page form is simple and only takes a few moments to fill out. It can be submitted to the FDA by mail or through a toll-free fax number. Additionally, for those with access to the world wide web (internet), a form can be filled out online https://www.accessdata.fda.gov/medwatch/medwatch-online.htm
Online reporting can also be accessed by clicking the MedWatch button on the FDA's homepage http://www.fda.gov
Project Inform has sample copies of the MedWatch Voluntary Reporting Form available through the Project Inform hotline (1-800-822-7422).