Adverse events and other unfavorable effects associated with a medical product. They include drug interactions, risks identified in non-clinical data, risks to those other than the patient (e.g. those preparing and administering the medical product), and risks based on pharmacologic class or current knowledge of the product. Factors such as potential misuse, abuse, or diversion of the product may also be considered.

FDA: Patient-Focused Drug Development Glossary | International Conference on Harmonisation (ICH) Guidelines