The reporting of suspected adverse drug reactions (side effects) to government regulators of the pharmaceutical industry by consumers (parents, guardians or caregivers) is key to identifying drug safety issues and improving prescription drug safety. It is estimated, for example, that only 1 to 10% of significant adverse drug reactions (ADRs) are reported to the Food and Drug Administration (FDA) in the United States. Almost all ADR reports come from the pharmaceutical industry, which is mandated to report ADRs.
This results in a significant underreporting of serious side effects. By 2015, for example, the FDA had received 655 reports of homicide committed by people on antidepressants, so the actual number was probably in the thousands.
Before you submit a government report, it might be helpful to get a free RxISK Report, which determines how likely it is that your adverse reaction was caused by a drug side effect.
Here are the ADR reporting websites in several countries:
- Australia – Department of Health: Therapeutic Goods Association
- Canada – Health Canada
- New Zealand – Pharmacovigilance Centre
- United Kingdom (England, Northern Ireland, Scotland, Wales) – Yellow Card: MHRA
- United States – FDA: MedWatch