Medicine adverse events
Find out how to report and search for medicine adverse events, including for vaccines and biologicals.
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About medicine adverse events
All medicines and vaccines can cause side effects or other unexpected problems. Medicines include prescription medicines, over-the-counter medicines and vitamins.
You can report any side effect or problem with a medicine. We especially want to know about:
- issues with new medicines or vaccines
- problems when medicines or vaccines interact with each other
- unexpected side effects not listed on the label or information sheet
- serious problems, for example that may have caused death or life threatening issues.
Find out more and get an overview of adverse event reporting for medicines:
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Overview of adverse event reporting for medicines
Learn how everyone can play an important role in monitoring the safety of medicines in Australia. -
How we manage your medicines adverse event reports
Find out what happens after you submit a report and actions we can take.
Report an adverse event
Anyone can make a report. You can submit a report - external site for yourself or on behalf of another person.
It’s easy to report a side effect online or by phone. There are different steps for consumers, health professionals and sponsors.
We encourage you to report side effects even if you’re not 100% sure the medicine caused them. You don't need to be certain, just suspicious!
For consumers and health professionals:
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Reporting adverse events for consumers
How to report a side effect, reaction or other problem with a therapeutic good. Your report can help keep others safe. -
Reporting adverse events for health professionals
How to report an adverse event or problem related to a medicine, vaccine or medical device as a health professional.
For industry:
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Reporting adverse events for industry
As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. -
Obligations to report adverse events for medicines and biologicals
Information on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
How we manage your adverse event report
After you report a problem with a medicine or vaccine, we log it in our system and check it for safety concerns. We may take action based on our assessment. This could include alerts, label changes, recalls, or further studies to keep medicines safe.
Find out about How we manage your medicine adverse event report.
Search adverse events for medicines, vaccines and biologicals
You can search for adverse events about medicines, vaccines and biologicals in our public 'DAEN Medicines' database:
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About the Database of Adverse Event Notifications (DAEN): medicines
Access information about suspected adverse events reported to us for medicines, vaccines and biological therapies. -
How to search the Database of Adverse Event Notifications (DAEN): medicines
Learn how to refine your searches, and use tables and graphs to interact with the data.