How do I report suspected adverse reactions after taking medicines or vaccines?
You can report suspected adverse reactions using an electronic reporting form at helsenorge.no. This form requires you to log in using an electronic ID. This prevents unauthorised persons from accessing your information.
Next of kin can also submit reports on behalf of the patient, but they must have power of attorney to do so in Helsenorge.no. You will not receive a response to this form.
Healthcare professionals shall report adverse reactions via melde.no.
What adverse reactions should I report?
First and foremost, you should report adverse reactions which are not listed in the package leaflet or which you find very burdensome (serious). See your doctor if you are experiencing troublesome adverse reactions.
Your report can provide us with valuable new information about how adverse drug reactions are affecting use of medicine(s) and quality of life amongst patients.
How to report adverse reactions
Please include the following information when reporting adverse reactions:
- name of the medicine or vaccine and when you started to take the medicine or date of vaccination
- description of the sequence of events, in as much detail as possible
- when the suspected adverse reaction(s) first started
- whether the reaction is still ongoing or has resolved
- any previous or concomitant medical conditions
- other medication, and details about other medication
- results of any blood tests
- whether a doctor has been contacted
If you are reporting on a vaccine:
- which dose the reaction(s) occurred after (i.e. first, second, third dose)
- whether a different type of vaccine was given at different doses. Please specify which
You can add attachments (such as photographs and printouts of test results). The report will be even more valuable if you provide as much information as possible.
Suspected adverse reactions to cosmetic products and dietary supplements must be reported to the Norwegian Food Safety Authority. Suspected adverse reactions to drugs in animals must be reported via a veterinary surgeon.
Report suspected adverse reactions on behalf of children
Children under 16: Parents and guardians can report suspected adverse reactions on behalf of their child.
Children over 16: Young people over the age of 16 can report suspected adverse reactions themselves, but they will need an electronic ID, such as Bank-ID. Parents can report if a power of attorney has been set up. Power of attorney can be set up digitally at helsenorge.no.
We urge children and young people who experience troublesome adverse reactions to contact a healthcare professional, such as a public health nurse or doctor, for assessment and advice. Healthcare professionals are obliged to report serious, new and unexpected reactions which they suspect may be caused by a medicine.
What will happen to my adverse reaction report?
Your report will be sent to the Norwegian Adverse Drug Reaction Registry (the NorADR registry) and you will receive a receipt with the reference number of the report. A copy of your report will always be stored in your Inbox on Helsenorge. Only you will have access to view this copy. Your report will be assessed together with other reports in the work to make medicine use safer. Read more about pharmacovigilance.
You will not receive any personal feedback, but we will contact you if we have any questions about your report. If you need to contact the Norwegian Medicines Agency in connection with your report, you must quote the reference number given in the receipt.