Even though the U.S. Food & Drug Administration (FDA) received over 2 million adverse drug event reports in 2019, most reports are never submitted to the agency. Let’s change this!

According to the FDA, reports to their MedWatch program* should be submitted when you, a loved one, or a patient:

  • Was hurt or had a bad side effect (including new or worsening symptoms) after taking a drug or using a medical device or product.
  • Used a drug, product, or medical device incorrectly which could have or led to unsafe use.
  • Noticed a problem with the quality of the drug, product or medical device.
  • Had problems with how a drug worked after switching from one maker to another maker.**

To call the FDA instead, dial 1-800-332-1088.


* FDA’s MedWatch is “the FDA’s medical product safety reporting program for health professionals, patients and consumers”.

** By “maker”, the FDA is referring to the manufacturer of the drug product you are filing a report about.