Should I report to FDA an adverse event for an unapproved animal drug?

Yes, FDA encourages veterinarians 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 a lack of effect. By reporting adverse events with animal drugs, including unapproved ones, you help FDA more easily identify and correct problems.

More information about how to report an adverse drug event to FDA.