How do I, my health care provider, or any informed individual report a problem or illness caused by drugs and other medical products regulated by the HHS Food and Drug Administration (FDA)?

Answer:

If you think you have suffered a serious harmful effect or illness from a product FDA regulates, such as drugs, medical devices, medical foods and dietary supplements, the first thing you should do is contact or see your health care provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA.

Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line at: http://www.fda.gov/medwatch/how.htm. 

You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or by reporting on-line at: http://www.fda.gov/medwatch/how.htm.

FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.

For a general, not serious, complaint or concern, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number in your region: http://www.fda.gov/opacom/backgrounders/complain.html. The identity of the reporter and/or patient is kept confidential.