Reporting Drug Side Effects or Drug Reactions

Reporting Drug Side EffectsMedEffect Canada

In Canada, suspected side effects or drug reactions can be reported to MedEffect Canada. MedEffect is a program that was set up to improve the safety, effectiveness, and access to medical products. It provides Canadians easy ways to:
Report a side effect or drug reaction (follow the link or call 1-866-234-2345)
Obtain new safety information on drugs and other health products; and
Learn more about the importance of reporting side effects.

Who Can Report Suspected Drug Side Effects and Reactions?

In Canada, anyone–including patients, caregivers, and healthcare professionals–can report suspected side effects and drug reactions.

What Can be Reported?

One doesn’t have to be certain that a treatment caused the reaction in order to report it. Issues reported to MedEffect Canada are mostly only suspected side effects/reactions.

Health Canada wants to know about all suspected side effects/reactions, but especially if they are:
• unexpected (were not listed as possible side effects associated with the drug), regardless of their severity;
• serious, whether expected or not; or
• related to a health product that has been on the market for less than 5 years. This time period would include all hepatitis C treatments allowed for use in Canada except for interferon and ribavirin.

Why Report Drug Side Effects and Reactions?

All drugs and health products have benefits and risks. Although medical treatments are carefully tested before they are allowed to be used in Canada, some reactions become evident only after the drug is being used by the general population. For example, the dangerous reaction of combining amiodarone, a treatment for some forms of irregular heartbeats, and sofosbuvir was discovered only after sofosbuvir was approved and being prescribed.

When you submit a suspected side effect report, your information is contributing to an ongoing collection of information about that product.

Your suspected side effect report may contribute to:
• the identification of previously unknown rare and/or serious side effects;
• changes in product safety information, or other regulatory actions such as the withdrawal of an unsafe treatment from the Canadian market;
• international data regarding benefits, risks, or effectiveness of drugs and health products; and,
• increased health product safety.

 Therefore, record them and report them.