Report Adverse Drug Reactions
Canadians: Submit to Health Canada
Health Canada collects data on adverse drug reactions — this is an important part of assessing drug safety!
Report Mild, Moderate or Severe Symptoms
Drug reaction reports can be for mild, moderate or severe symptoms. Even if you take multiple drugs you can make a report.
Report Anonymously by Phone
Reports can be made anonymously! Toll-free: 1-866-234-2345.
Report On-line, by Mail or Fax
There is more information on the Health Canada Adverse Reaction Reporting site where you can:
- complete and submit your report on-line;
- download and print a paper copy of the reporting form to submit a report by mail or fax; or
- phone one of the Regional Adverse Reaction Monitoring Offices.
Learn About Safety Warnings
Prescription and Over-the-Counter Drugs
If you want to learn about safety warnings for prescription drugs and over-the-counter drugs, subscribe to MedEffect www.healthcanada.gc.ca/medeffect. Subscriptions are free.
Americans: Submit to FDA's MedLine
Report to MedWatch Using Online Form 3500
The FDA's MedLine site allows you to report
serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of the following:
- FDA-regulated drugs,
- biologics (including human cells, tissues, and cellular and tissue-based products)
- medical devices (including in vitro diagnostics)
- special nutritional products and cosmetics.
Updated May 29, 2018