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Report a side effect

For industry information about COVID-19, visit our COVID-19 health product industry section.

Anyone can report a side effect to a health or cannabis product. Your report can help make these products safer for all Canadians.

Report the issue as soon as possible after the reaction or problem occurred. You should do this even if you are not sure if a particular health or cannabis product was the cause.

Every report counts. Together they tell a story. Report!

Choose a product

Drugs

Drugs include pharmaceutical drugs, biologics and radiopharmaceutical drugs.

Pharmaceutical drugs include prescription drugs (require a medical prescription to be dispensed) and non-prescription drugs (obtained without a prescription).

Biologics (biotechnology products and blood products) are drugs that come from living organisms or from their cells. They are used to treat medical conditions such as diabetes and some forms of cancer.

Radiopharmaceuticals are pharmaceutical drugs that have been made radioactive for the purpose of diagnosing illness.

Medical devices

Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits. They are used to treat, diagnose or prevent a disease or abnormal physical condition.

Natural health products

Natural health products are naturally occurring substances. They are often made from plants, but can also be made from animals, micro-organisms and marine sources. They are used to prevent or treat an illness or condition, reduce a health risk or maintain good health. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

Vaccines

Vaccines are products that produce immunity to a specific disease. Most vaccines are given by injection (needle) but some are given orally (by mouth) or nasally (sprayed into the nose). They protect people against serious and potentially deadly diseases, such as diphtheria, measles, polio and tetanus.

Cannabis

Cannabis refers to the plant Cannabis sativa, which is used for its effects on the mind. It is also used for medical, social or religious purposes. Marijuana is a slang term for the dried flowers, leaves, stems and seeds of the cannabis plant.

Veterinary drugs

Veterinary drugs (prescription and non-prescription) are used to diagnose, treat or prevent diseases in pets and food-producing animals.

Veterinary health products (such as vitamins and minerals) are low risk drugs used to maintain or promote the health and welfare of pets and food-producing animals. They are not used to diagnose, treat or prevent diseases.

Why you should report

All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers.

Your report helps to indicate if there is an issue with a health or cannabis product (a signal). Each single case has to be looked at and considered as unique. However, more than 1 report is usually needed to generate a signal.

A signal is an initial indicator of an issue with the drug, health or cannabis product. However, it is not proof the drug, health, or cannabis product caused the adverse reaction or problem. We evaluate every signal to confirm or disprove a connection between the product and the reaction or problem.

Controlled substances can also cause potential risks to your health.

Reporting a suspected adverse reaction or medical device problem helps us:

  • identify potential safety issues
  • improve health product safety for all Canadians
  • identify previously unrecognized, rare or serious adverse reactions or problems
  • add to international data on the benefits, risks or effectiveness of drugs, health and cannabis products
  • communicate changes in product safety information to industry, hospitals, health care providers and consumers
  • undertake regulatory actions, such as changing the product label or removing a product from the Canadian market

We monitor all reports and take the appropriate steps to protect Canadians.

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2023年09月08日

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