An Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes side effects resulting from the authorised use of a medicinal product at normal doses, medication errors, off-label use and the misuse and abuse of medicinal products.
The information on side effects helps in enhancing the safety of products as the Medicines Authority and the product's manufacturer will have a more complete and accurate picture of the experience patients are having with their medicines.
Medicine users or their relatives can report side effects directly to the Medicines Authority. Healthcare professionals are encouraged to report all ADRs and medication errors to the Medicines Authority. For the scope of this reporting system, medication errors that require reporting to the Medicines Authority are those which are related to the use of medicinal products.