Adverse Drug Reactions (ADR)
An Adverse Drug Reaction (adverse reaction; undesirable effact) is a respond to a medicinal product which is noxious and unintended. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Use outside the marketing authorisation includes off-label use, overdose, misuse, abuse and medication errors.
Marketing authorization holders are obliged to collect all ADRs they become aware of. The same applies for the Nation Competent Authorities within the European Union.
Information regarding suspected ADRs associated with medicinal products marketed in the European Union are collected in the European Database and accessible via the following link: