Reporting Medication Adverse Events

If you or someone in your family has experienced a serious side effect, or adverse event, you’re encouraged to report it to your doctor. You may also report it to the FDA directly.

There are 4 ways to report adverse events:

  1. Report Online Using the Medwatch Form
  2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn.
  3. Call FDA at 1-800-FDA-1088 to report by telephone
  4. Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500

Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures for:

  • Prescription or over-the-counter medicines
  • Biologics
  • Medical devices
  • Combination products
  • Special nutritional products (infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages