Animal & Veterinary
Should I report to FDA an adverse event for an unapproved animal drug?
Yes, FDA encourages you to report adverse events for any drug, even if the drug is unapproved. An adverse drug event, also called an adverse drug experience or ADE, is an undesired side effect associated with a drug, or the drug doesn’t do what you expect it to do (it has a lack of effect). By reporting adverse events with animal drugs, including unapproved ones, you help FDA more easily identify and correct problems.