Canada Vigilance adverse reaction online database
- Foreign risk notification for medical devices guidance document: Background [2021-01-14]
- Amendments to the Food and Drugs Act: Guide to new authorities [2021-01-14]
- Incident reporting for medical devices: Guidance document [2021-01-14]
- Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14]
- Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada [2020-12-23]
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
- MedEffect Canada Home Page
- Report an Adverse Reaction
- Learn About Adverse Reactions
- Advisories, Warnings and Recalls
- MedEffect Canada RSS Feeds and MedEffect e-Notice
- Health Product InfoWatch
- Reports and Publications
- Annual trends for the adverse reaction case reports of health products and medical device problem incidents to Health Canada (2008-2017)
For industry information about COVID-19, visit our COVID-19 health product industry section.
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products.
Adverse reaction reports are submitted by:
- consumers and health professionals, who submit reports voluntarily
- manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act
This database includes data from 1965 to 2020-12-31. Information about vaccines used for immunization has been included in the database since January 1, 2011. Information about human blood and blood components has been included in the database since September 1, 2015.
The database should not be used on its own to evaluate a health product's safety profile as It does not provide conclusive information on the safety of health products. It should not be used as a substitute for medical advice. If you have a medical concern, consult a qualified health professional. For more information, consult our Interpretation of suspected adverse reaction data page.
For general questions about the content of the Adverse Reaction Online Database or for technical support, please contact the Canada Vigilance Program.
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