Learn / Medication Safety Reporting
Medication safety reporting
Reporting a suspected adverse event in Australia
Anyone can report a suspected medicine adverse event to the TGA. A report documents a suspected relationship. It does not require you to prove causation.
Pharmacovigilance is how regulators notice problems that trials were too short, too selected, or too small to see. It only works if people report. It also only works if reports are not mistaken for incidence.
1 · Statement
An adverse-event report to the TGA documents a suspected relationship. It does not prove that a medicine caused an event, and DAEN counts are not incidence rates.
2 · Classification
Established. This is how spontaneous pharmacovigilance systems are defined by the regulator.
3 · Papers
4 · Claim limitation
Under-reporting, missing denominators, and confounding are structural.
Last reviewed
1 September 2026
In Australia, consumers can report suspected adverse events to the Therapeutic Goods Administration. You do not have to be certain. You do not have to wait for a specialist to agree. You do have to understand that a published report in DAEN is not a rate, and that missing reports are not evidence of safety.
Sources used on this page
- Therapeutic Goods Administration (2026). Reporting adverse events for consumers.
- Therapeutic Goods Administration (2026). Database of Adverse Event Notifications (DAEN).
Paradoxical.life provides evidence and self-documentation tools, not medical advice. If you have concerns about your health, medication or mental state, speak with a qualified medical practitioner.