Adverse Reaction Reporting for Specific Products

If you are currently suffering from a side effect - also known as an adverse reaction - you should contact your health care provider, your local health authority, or the Canadian Association of Poison Control Centres.

Who can report?

Manufacturers, professionals, and consumers can report adverse reactions to Health Canada and its partners using the programs listed below. Depending on the product, reporting is either voluntary or mandatory.

Clinical Trials

• Biological Drugs, Pharmaceutical Drugs, and Radiopharmaceuticals
• Natural Health Products

Marketed Products

• Blood and Blood Components
• Blood - Recombinant and Fractionated Blood Products
• Cells, Tissues and Organs
• Consumer Products
• Cosmetics
• Drugs for Humans
• Drug Used in Animals
• Food
• Medical Devices
• Natural Health Products for Humans
• Pesticides
• Radiation-Emitting Devices
• Semen - Assisted Conception
• Vaccines to Prevent Disease in Humans
• Veterinary Biologics

Clinical Trials

Biological Drugs, Pharmaceutical Drugs, and Radiopharmaceuticals

Trial sponsors, also known as applicants, must report to Health Canada any serious and unexpected adverse drug reaction (ADR) that occurred inside and outside Canada while the drug (includes biological drugs) is in clinical trials in Canada. For further information follow the instructions for the Clinical Trials - Adverse Drug Reaction (ADR) Reporting.

Examples: vaccines, hormones used as therapeutic and diagnostic agents, enzyme replacement therapies, insulin, recombinant products such as monoclonal antibodies, genetic therapies and recombinant DNA products.

Radiopharmaceuticals include drugs either of chemical or biological origin which are intentionally made radioactive for the purpose of diagnosing illness, as well as kits that are used for the preparation of radiopharmaceutical and radionuclide generators. Radiopharmaceuticals are used as diagnostic or therapeutic agents and are always prepared and administered by health care professionals; they are never self-administered.

Natural Health Products

The sponsor is required to report to Natural Health Products Directorate Clinical Trial Unit any serious unexpected adverse reactions to the natural health product (NHP) that has occurred inside or outside Canada. For further information regarding when and how an Adverse Reaction report must be filed, see the Clinical Trials for Natural Health Products Guidance Document.

Examples of natural health products are vitamins, minerals, herbal products, homeopathic medicines.

Marketed Products

Blood and Blood Components

Blood and blood components that consist of whole blood or are derived from whole blood through a separation process which have not undergone secondary manufacturing and have no Drug Identification Number (DIN) can be reported locally to the Canadian Blood Services or Héma-Québec who must report them to Health Canada. These may also be reported to the Provincial/Territorial Blood Coordinating Offices.

Examples of blood and blood components include cryoprecipitate, plasma, platelets, red blood cells and whole blood.

Blood - Recombinant and Fractionated Blood Products

You can report suspected adverse reactions to recombinant and fractionated blood products which have undergone a manufacturing process and that have a Drug Identification Number (DIN) to the Canada Vigilance Program through the MedEffect Canada section of the Health Canada Web site. Follow the instructions for reporting adverse reactions. These may also be reported to the Provincial/Territorial Blood Coordinating Office.

Examples of recombinant and fractionated blood products include albumin, plasma derived clotting factors and immune globulins.

Cells, Tissues, and Organs

Suspected adverse reactions following transplantation of cells, tissues or organs, including those involving the transmission of an infectious disease or disease agent can be reported to the Canada Vigilance Program. Follow the instructions for reporting adverse reactions provided in the MedEffect Canada section of the Health Canada Web site.

Examples of cells, tissues, and organs include organs for transplantation, ocular tissue, islet and lymphohematopoietic cells that are minimally manipulated.

Consumer Products

To report a product-related injury or death, or a safety-related issue with a consumer product, you are encouraged to report the incident directly to Health Canada by completing the Consumer Product Incident Report Form.

Examples of consumer products include electronics, baby walkers, clothing, toys, children's furniture, small appliances, house wares, household chemicals, bicycles, playground equipment, pools, skates, scooters, hockey helmets, hot tubs, and tents. Adverse reactions related to cell phones should be reported to Industry Canada.

Cosmetics

Cosmetics are defined as any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair, or teeth and includes deodorants and perfumes.

This definition also includes cosmetics used by professional aesthetic services, and bulk institutional products (such as hand soap in school rest rooms).

For a product-related injury or death, or a safety-related issue with a cosmetic or a personal care product, you are encouraged to report the incident directly to Health Canada by completing the Consumer Product Incident Report Form.

Examples of cosmetics products include: shampoo, tooth whiteners, shaving cream, lipstick, hair dyes and tints, depilatories, soaps, moisturizers, nail polish and removers, and self-tanning products.

Drugs for Humans

Suspected adverse reactions to drugs marketed in Canada, including prescription and non-prescription drugs can be reported to the Canada Vigilance Program. Follow the instructions for reporting adverse reactions provided in the MedEffect Canada section of the Health Canada Web site.

Examples of prescription and non-prescription medicines (over-the-counter) include: pharmaceuticals, biologics (such as insulin and vaccines), radiopharmaceuticals, disinfectants and sanitizers with disinfectant claims.

Drugs Used in Animals

Report suspected adverse reactions to drugs used in animals - including a lack of effect - through the Adverse Drug Reactions (Pharmacovigilance) Web site. You will also find safety information such as advisories, warnings, and recalls for veterinary products on the Veterinary Drugs Directorate section of the Health Canada Web site.

Examples of drugs used in animals include prescription and non-prescription medicines (over-the-counter) such as analgesics, antibiotics, antiparasitics, and growth promotants.

Food

Adverse reactions to food products experienced by consumers or reported to industry should be reported to the Canadian Food Inspection Agency. You can use the Recall Contact List for Canadian Food Inspection Agency (CFIA) Notification to find local phone numbers.

Examples of food include dairy, egg, egg products, fish, seafood, honey, fresh/processed fruits and vegetables, organic products, meat and poultry, and retail food.

Medical Devices

Medical device users are encouraged to report device-related incidents directly to Health Canada by completing a Medical Device Problem Report. Completed problem reports and general inquiries are to be directed to the Operational Centre of the Health Products and Food Branch Inspectorate in your area.

Examples of medical devices include defibrillators, syringes, surgical lasers, hip implants, medical laboratory diagnostic instruments (including X-ray, ultrasound devices), contact lenses, and condoms.

Adverse reactions and incidents relating to radiation emitting medical devices can also voluntarily be reported to the Radiation Emitting Devices Program.

Natural Health Products for Humans

Suspected adverse reactions to natural health products marketed in Canada, such as herbal products, natural remedies and homeopathic medicines, can be reported to the Canada Vigilance Program provided in the MedEffect Canada section of the Health Canada Web site. Follow the instructions for reporting adverse reactions.

Examples of natural health products include vitamins, minerals, traditional medicines such as traditional Chinese medicines, probiotics, and other products like amino acids and essential fatty acids.

Pesticides

Report any incident related to a pesticide, whether it involves adverse effects on a human, an animal, or the environment, to the manufacturer using the contact information available on the pesticide label. Manufacturers are required by law to report to Health Canada any incident information they receive related to their product.

You may also report an incident directly to Health Canada by using the appropriate Pesticide Incident Reporting Form for the Public available on the Pesticide Incident Reporting page.

Examples of pesticides include insecticides, herbicides, fungicides, and various other substances (or mix of substances) used to control pests, such as insects, fungus, weeds, animal or bacterial organisms.

Radiation-Emitting Devices

Report an adverse reaction or an incident related to a radiation-emitting device to the Consumer and Clinical Radiation Protection Bureau.

Examples of radiation-emitting devices include ultrasound equipment, X-ray devices, microwave ovens, tanning equipment, or lasers.

For radiation-emitting devices used to diagnose or treat a medical condition, adverse reactions and injuries are subject to mandatory reporting to the Medical Devices Program and may be voluntarily reported to this program.

Semen - Assisted Conception

Physicians who have performed inseminations are to report suspected transmissions of an infectious agent by donor semen to the semen processor. The semen processor is then responsible for reporting these suspected transmissions, to the Minister of Health, by sending a copy of the report to the Health Products and Food Branch Inspectorate how to Submit a Consumer Complaint.

This only applies to donor semen that is used or intended for use in assisted conception.

Vaccines to Prevent Disease in Humans

Health care professionals are encouraged to report any adverse reactions following immunization to their local health unit. Patients are encouraged to report adverse events to their vaccine provider or other health care professional.

Examples of preventative vaccines include vaccines against polio, measles, and rubella (German measles).

Veterinary Biologics

The Veterinary Biologics Section (VBS) of the Canadian Food Inspection Agency (CFIA) should be notified of suspected adverse reactions to veterinary biologics. Veterinary biologics include the following classes of products: vaccines against viral, bacterial, protozoan and fungal diseases, antibody products for the prevention or treatment of infectious diseases in animals and vitro diagnostic kits, including those derived through biotechnology.

Examples of veterinary biologics products include rabies, canine distemper, or equine West Nile vaccines. The Guidelines for Reporting Suspected Adverse Events to the Veterinary Biologics Section (VBS) provide more information. The recommended form used to notify VBS of suspected adverse reactions is available for downloading from the Guidance for Reporting Suspected Adverse Events Web site.