Reporting of adverse reactions and The Norwegian Adverse Drug Reaction Registry
What is an adverse reaction?
An adverse reaction is a harmful and unintended effect of a medicine. This applies regardless of whether or not the medicine has been used as described in the product information.
The definition also includes harmful and unintended effects linked to:
- misuse (incorrect use)
- medication errors
- dosing errors
- off-label use (treatment not covered by the approved indication for use)
- occupational exposure
Reporting adverse reactions
Reports on suspected adverse drug reactions can be submitted by healthcare professionals, patients, next of kin and pharmaceutical companies.
Reports of suspected adverse reactions are registered in The Norwegian Adverse Drug Reaction Registry.
Reporting suspected adverse reactions is an important part of the pharmacovigilance system.