Adverse Reaction Database

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Canada Vigilance Adverse Reaction Online Database

The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products.

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.

Information concerning vaccines used for immunization has only been included in the database since January 1, 2011. Information concerning human blood and blood components has only been included in the database since September 1, 2015.

Indication data has recently been added to the data extract files and the Detailed Adverse Reaction Report. Indication refers to the particular condition for which a health product was taken. For example, diabetes is an indication for insulin. Health products are often authorized for use in treating more than one indication.

The database cannot be used on its own to evaluate a health product's safety profile. It does not provide conclusive information on the safety of health products, and is not a substitute for medical advice. Should you have an issue of medical concern, consult a qualified health professional. For more information consult our Web page: Interpretation of suspected adverse reaction data.

This database includes data from 1965 to 2017-03-31.

Using the Database

Alternative Access to Data (Data Extract)

The data extract provides the full data set from the Canada Vigilance Adverse Reaction Online Database as a series of compressed ASCII text files and is intended for users who are familiar with database structures and capable of setting up their own queries.

Useful Links

  • Procedure - The Release to the Public of Information Obtained from Adverse Reaction and Medical Incident Reports.
  • Drug Product Database - contains information on drugs approved for use in Canada, including human pharmaceutical and biological drugs, veterinary drugs and disinfectant products.
  • Licensed Natural Health Products Database - contains information on natural health products that have been issued a product licence by Health Canada.
  • Advisories and Recalls - provide new safety information for health professionals and consumers on health products, such as pain relievers, cold medicines, prescription drugs, medical devices, vaccines and natural health products.

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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