Adverse events

Find out how to report adverse events for therapeutic goods, including side effects, and why it's important.

This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page.

We want you to report any unexpected problems or when something goes wrong with a medicine or medical device. We call these adverse events, and your reports help us to monitor the safety of therapeutic goods.

Adverse events include:

side effects
faults
unintended outcomes.

Database of Adverse Event Notifications (DAEN)

All adverse events reported to us are added to this searchable database.

Reporting and searching for adverse events

There are different steps for medicines and medical devices with adverse events reporting. Find out more:

Medicine adverse events

Find out how to report and search for medicine adverse events, including for vaccines and biologicals.
Medical device adverse events

Find out how to report and search for medical device adverse events.

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Product regulation

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Adverse events

Database of Adverse Event Notifications (DAEN)

Reporting and searching for adverse events

Medicine adverse events

Medical device adverse events

Site notifications

Product regulation

Safety and shortages

Resources and guidance

Business services

Adverse events

Database of Adverse Event Notifications (DAEN)

Reporting and searching for adverse events

Medicine adverse events

Medical device adverse events