How to Report Drug Side Effects to the FDA

fdadrugreportHelp Protect Others from Dangerous Drugs

Q: I really appreciate your information on drug side effects, which has helped both of my parents get off the drug treadmill! My father-in-law Stu had a very bad reaction to a cholesterol-lowering drug and almost died of damage to his liver. I asked Stu’s doctor if he had reported this to the FDA, and he said he was not required to and didn’t have time to do the paperwork. Can I report it?

A: On the one hand it’s shameful that the FDA does not require reporting of adverse effects of drugs, and on the other hand it happens so frequently that doctors would indeed drown in the paperwork if they were required to report them all. You would think that this would inspire doctors to make changes in how they prescribe drugs, but most of them are on the drug prescribing treadmill!

Reporting adverse drug effects/events to the FDA is a great public service. The more people who let the FDA know when they or a loved one have been harmed by a drug, the more pressure there will be to do something about it.

You can report adverse events to the FDA through their MedWatch Online Voluntary Reporting Form.

If you prefer not to make the report online, you can download and print out a form at and either fax the completed 3500 form and your attachments to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.