Database of Adverse Event Notifications (DAEN)

Therapeutic Goods Administration (2026). Australian medicines regulator.

Population: People in Australia for whom a suspected adverse event was reported
Sample: Spontaneous reports; denominator unknown
Condition: Suspected medicine adverse events
Medication focus: Medicines, vaccines and biologicals reported to the TGA
Jurisdiction: Australia
Last reviewed: 1 September 2026

Plain-language finding

DAEN publishes information from suspected adverse event reports. A report documents a suspected relationship. It does not require the reporter to prove that the medicine caused the event, and a published report is not evidence of incidence or causation.

Important limitation

No reliable denominator. Under-reporting is expected. Reports can be incomplete, duplicated, or confounded. Counts must never be read as rates. Absence of a report is not evidence of absence.

Why we cite this

The public Australian window onto suspected medicine adverse events, with its limitations made explicit.

tga · pharmacovigilance · daen · australia

Research demonstrates a statistical relationship. Association is not causation. Timing, dose, confounding and missing data still matter.

Original source

Claims this source supports

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.
Last reviewed 1 September 2026