Report a side effect
For industry information about COVID-19, visit our COVID-19 health product industry section.
Anyone can report a side effect to a health or cannabis product. Your report can help make these products safer for all Canadians.
Report the issue as soon as possible after the reaction or problem occurred. You should do this even if you are not sure if a particular health or cannabis product was the cause.
Every report counts. Together they tell a story. Report!
Choose a product
Why you should report
All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers.
Your report helps to indicate if there is an issue with a health or cannabis product (a signal). Each single case has to be looked at and considered as unique. However, more than 1 report is usually needed to generate a signal.
A signal is an initial indicator of an issue with the drug, health or cannabis product. However, it is not proof the drug, health, or cannabis product caused the adverse reaction or problem. We evaluate every signal to confirm or disprove a connection between the product and the reaction or problem.
Controlled substances can also cause potential risks to your health.
Reporting a suspected adverse reaction or medical device problem helps us:
- identify potential safety issues
- improve health product safety for all Canadians
- identify previously unrecognized, rare or serious adverse reactions or problems
- add to international data on the benefits, risks or effectiveness of drugs, health and cannabis products
- communicate changes in product safety information to industry, hospitals, health care providers and consumers
- undertake regulatory actions, such as changing the product label or removing a product from the Canadian market
We monitor all reports and take the appropriate steps to protect Canadians.
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
- MedEffect Canada
- Advisories, warnings and recalls
- Adverse Reaction Database
- Medical device incidents database
- Medical devices establishment licence listing
- Medical Device Active Licence Listing
- Mandatory hospital reporting regulations
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