How to report a side effect

If you or the person you are reporting on behalf of are currently suffering from severe side effects, you should contact your local doctor or other medical health professional before reporting the side effect.

Your information about complaints and side effects provides us with important feedback on our products. If you have experienced a side effect or a product complaint to a Novo Nordisk product, we encourage you to report this to Novo Nordisk. 
 

Contact Novo Nordisk

Report directly to Novo Nordisk Canada:

E-mail: nnci-drugsafety@novonordisk.com
Fax: +1 866 665 2612
Phone: +1 800 465 4334 (Customer Service)

 

What is a side effect?

A side effect (also known as adverse reaction) is a harmful and unintended response to a pharmaceutical product. This includes any undesirable patient effect suspected to be associated with pharmaceutical product use. An unintended effect, pharmaceutical product abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are also considered reportable side effects.

 

Why should you report complaints and side effects to Novo Nordisk?

Although our products are tested extensively in clinical trials before they are authorized, not everything is known about their side effects until they have been used by many people over time. Novo Nordisk routinely monitors the safety of all our products. By reporting complaints and side effects, you are giving us important feedback which will ultimately help us take appropriate actions and to provide better instructions for how to use our products.

 

What information to provide

When reporting side effects please provide the following information, if possible:

 

 
Product details

  • Name of product (brand name)?
  • What disease is the product used for?
  • How do you take the product (dose, how often)?
  • What is the product batch number?
  • If it concerns a product fault: Which product part and product function is affected? How did the fault occur? Is a sample available?
  • What were the actions taken to the product? Has the product been discontinued? Any changes in product dose? Were the actions taken to suspected product advised by your HCP?
 

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
  • Gender
  • Age, date of birth or age group (e.g. child, adolescent, adult, elderly)
  • Country of residence
 

Reporter details
  • Name
  • Contact details
 

Data privacy

All personal information reported in relation to a complaint or a side effect will be processed in accordance with applicable data protection legislation:

  • Your report is used solely for the scientific evaluation of the medicine and product quality
  • Side effects are filed in our global safety database and the data is regularly analysed for overall patterns
  • Novo Nordisk may share reported complaints and 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

For more information, please see our Privacy Policy.