Adverse Event Reporting


Why report an adverse event?

The TGA monitors adverse events (such as side effects) related to medicines and vaccines to safeguard and enhance the health of the Australian community. Unfortunately, it is not possible to know all potential adverse events of a medicine or vaccine before it is approved for use.

When people tell us about their experiences using a particular medicine or vaccine, it helps us to monitor the safety of those products.

More information: Reporting adverse events involving medicines, vaccines or medical devices.

About reporting

We prioritise issues that may:

  • have adverse health consequences for consumers as a result of public access to dangerous or inappropriate goods,
  • affect confidence in our regulatory processes or contribute to a loss of confidence in therapeutic goods in Australia.

Report an adverse event to a medicine

You can submit an adverse event as either a registered or unregistered user. As a registered user, your contact details will be pre-populated, you can save drafts and also view or amend previously submitted reports.

You can report adverse events of any medicine or vaccine, including medicines you get on prescription and over-the-counter, or complementary medicines that you buy from a pharmacy, supermarket, health food shop or the internet.

If you believe you are experiencing an adverse event it is important to speak to a health professional.