How to report side effects

This can be any unfavourable and unintended sign, symptom, or disease associated with the use of the product.

An example of a side effect could be a rash developing shortly after taking a product. 

Side effects may arise from use of the product within or outside the indication mentioned in the package leaflet.

Novo Nordisk routinely monitors the safety of all our products. This includes review of safety data from clinical studies and side effects received on marketed products to see if there is any new information. By reporting side effects to a Novo Nordisk product, you are giving us important feedback which ultimately will help us take appropriate actions and to provide better instructions for how to use our products. 

Reports will be shared with authorities, who will also analyse the data. In this way patients are best protected as both the company and the authorities are analysing the data to see if there are any new side effects that patients and health care professionals should be aware of.

Side effect details:

• Description of the suspected side effect including whether you have recovered from the event
• When did the side effect occur?
• Are you experiencing other medical conditions?
  
  

Patient details:

• Initials of the person experiencing the side effect
• Age, date of birth or age group (e.g. child, adolescent, adult, elderly)
• Gender
• Country of residence
   

Products details:

• The product name (brand name)
• The dose of the product used when the side effect appeared
• How long have you used the product
• What disease is the product used for?
• Are you still taking the product?
• Information about any other products you have taken around the same time (including non-prescription products, herbal remedies and contraceptives)

As Novo Nordisk has an obligation to seek additional information from a Health Care Professional with knowledge about the side effect, please confirm whether Novo Nordisk can contact your doctor?

• If “Yes”, please provide your doctor´s contact details
• If “No”, Novo Nordisk will respect that and not contact your doctor

Your report is used solely for the scientific evaluation of the medicine.

After careful evaluation of each report received, side effects are filed in our global safety database and regularly used to look for overall patterns. Novo Nordisk may share the details of reported side effects with Health Authorities as mandated by law. However, no personally identifiable details will be shared.

Novo Nordisk will retain the data as long as required by law.