Yes, FDA encourages you to report problems with any drug, even if it’s unapproved. Problems include adverse drug events and product defects. 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—the drug doesn’t do what you expect it to do. Adverse drug events also include unfavorable reactions in people who handle the drug. Product defects are problems such as defective packaging or an abnormal appearance of the drug. By reporting adverse drug events and product defects with animal drugs, including unapproved ones, you help FDA more easily identify and correct problems.