Adverse Reaction Information

Health products, ranging from pharmaceutical drugs to natural health products and medical devices, play an important role in the lives of Canadians, and in Canada ’s health care system. There are over 22,000 human drug products and 40,000 medical devices available on the Canadian market. Millions of people trust that the products available have passed Health Canada's rigorous safety standards and will help to deliver desired health outcomes.

Health Canada continues to monitor the safety, effectiveness and quality of health products after they reach the marketplace. The department routinely evaluates Canadian adverse reaction reports and selected foreign reports, from manufacturers, health professionals and consumers. These evaluations may include a comprehensive reassessment of the benefit-risk profile of a product. If a safety issue is identified, appropriate action is taken. Such actions range from distributing new product safety information to the public and/or the health care community, to recommending changes to the product's labelling or requesting the removal of the product from the market.

All health products carry risks and benefits. Many of these risks are identified in pre-market testing and can be managed as “expected” or “tolerable” side effects that are outweighed by the product’s benefits. However, once a product is made available on the Canadian market, new “unexpected” or undesirable side effects, referred to as "adverse reactions", are sometimes discovered when the product is used in “real world” conditions.

Health Canada ’s Role

• Build awareness and encourage reporting of adverse reactions by health professionals and consumers through initiatives such as MedEffect, which provides access to adverse reaction reporting forms, new product safety information advisories, warnings and recalls, an e-sign up for automatic notification about new product information, and a complete archive of the CARN (Canadian Adverse Reaction Newsletter).
• Provide channels for reporting of adverse reactions to veterinary drugs.

Related Resources

Health care professionals are encouraged to report adverse events following immunization to their local health unit. Visit the Public Health Agency of Canada's Immunization and Respiratory Infections Division Web site for more information.