Safety monitoring: Medicines

We monitor the safety of medicines in Australia and can take action to address safety concerns. 

The links below contain information for consumers, patients and carers about the safety of medicines.

Reporting medicine or vaccine adverse events

Consumers: report a side effect of a medicine or vaccine using the online form.

Health professionals:

• report an adverse event of a medicine or vaccine
• report via email, fax or mail using the National Adverse Events Following Immunisation (AEFI) reporting form

More information

• Database of Adverse Event Notifications (DAEN)
• Overview of how TGA manages medicine adverse event reports
• TGA safety monitoring of medicines

• Reporting adverse events

• Reporting adverse events to medicines and vaccines

• Medicines safety
• Adverse event monitoring internationally
• N-nitroso compounds in 'sartan' blood pressure medicines

COVID-19 safety

• COVID-19 vaccine safety monitoring and reporting
• Communicating COVID-19 safety information
• Australia's COVID-19 vaccine safety monitoring system
• COVID-19 vaccine safety monitoring plan