Report issues with medicines and medical devices to help make them safer

Have you experienced an issue with a medicine or medical device? 

Adverse events are side effects or problems associated with the use of medicines, vaccines or medical devices.

You can report adverse events for:

• prescription medicines, vaccines, medical devices, complementary medicines, supplements and vitamins that are included in the Australian Register of Therapeutic Goods (ARTG)
• unapproved and counterfeit medicines and medical devices, including products bought from overseas.

Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices. 

Reporting helps keep others safe by uncovering potential problems sooner, so we can take action faster. This can include issues that are rare, develop slowly or only affect a certain group of people such as those with an underlying illness. 

Report a medicine or vaccine adverse event

You can report a medicine or vaccine adverse event in a number of ways:

• Online through the Adverse Event Management System
• Call 1300 633 424 Monday to Friday, 9am to 5pm AEST
• Ask your doctor or pharmacist to report it to us

Report a medical device adverse event

You can report a medical device adverse event in a number of ways:

• Online through the Medical Device Incident Report System
• Call 1800 809 361 Monday to Friday, 8:30am to 5:30pm AEST
• Email iris@health.gov.au
• Ask your doctor or pharmacist to report it to us

Remember – seek immediate medical attention if you’re unwell or worried about an adverse event.

Visit our Reporting adverse events for consumers page for more information. 

Translated resources

Information on reporting adverse events is available in 5 languages, as well as a print-friendly English version:

• Adverse Event Reporting - Arabic
• Adverse Event Reporting - Chinese (Simplified)
• Adverse Event Reporting - English
• Adverse Event Reporting - Hindi
• Adverse Event Reporting - Korean
• Adverse Event Reporting - Vietnamese

Authorised by the Australian Government, Canberra