How to Report Adverse Drug Reactions

Most of the time, FDA approved drugs are used without ill effect. However, any drug has the potential to have an adverse effect on a particular patient. Reporting these effects is instrumental in ensuring the safety of future patients by demonstrating if a pattern of reactions is emerging. The FDA has a system in place so that reporting drug reactions is a simple procedure.

Instructions

• 1

  See a doctor. If you are experiencing an adverse effect from a drug, you should consult with a physician first to ensure your safety. Your physician should know about the side effects the drug has had on you, so he can consider those when making decisions regarding your health and that of other patients.

• 2

  Ask your doctor or other health care professional to file a report with the FDA's Adverse Event Reporting System.

• 3

  Send a report about your drug reaction directly to the drug manufacturer. Either you or your health care professional (such as a doctor, nurse, or pharmacist) can report the circumstances of your adverse drug reaction directly to the maker of the drug in question. The FDA requires the drug manufacturer to report back to it.

• 4

  If you don't choose either of the above options, your can file your own report with the FDA via the AERS website. The only way you'll know for sure that your report was filed is if you do it yourself. Download the form at http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf and fill it out, including dates and specific drug name. Submit it via the website or fax it to (800) FDA-0178) You can also phone your report to (800) FDA-1088.