Overview of adverse event reporting for medicines

Adverse events are unexpected problems that happen when using a medicine, vaccine, or medical device. They can include side effects or issues that cause harm, or that could have caused harm. 

Examples of adverse events include: 

• feeling sick after taking a medicine or getting a vaccine
• a medical device not working properly and putting someone at risk
• a lab test showing something unusual.

Sometimes, these events aren’t caused by the product itself. They might happen because of how it’s used or how different products interact. Just because an adverse event happens, doesn’t mean the product is faulty. 

Our safety monitoring program relies on reports from consumers and health professionals.

Every report counts. One report may not be enough to determine if a therapeutic good caused an adverse reaction, but all reports help us build a picture of a product's safety profile.

Our work is based on applying scientific and clinical expertise to decision making. We decide whether the benefits to consumers outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods.

All medicines and vaccines can cause side effects or other adverse events. 

Medicines include:

• prescription medicines
• over-the-counter medicines that are purchased without a prescription
• complementary medicines, such as herbal medicines, naturopathic or homeopathic preparations and nutritional supplements such as vitamins and minerals.

Adverse events we need to know about for medicines

You can report any adverse event, 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 that may have caused:
  • death
  • life-threatening illness or injury
  • hospital admission or longer hospital stay
  • time away from work or daily activities
  • higher medical costs
  • birth defects.

Anyone can make a report. You can submit a report for yourself or on behalf of another person. 

It’s easy to report an adverse event online or by phone. There are different steps for consumers, health professionals and sponsors, and if your report is about a medicine or a medical device. We will explain the differences when you make a report. 

We encourage you to report adverse events or side effects even if you’re not 100% sure the medicine caused them. You don't need to be certain, just suspicious!

Please give us as much information as possible in your report. The more details you can give, the better picture we can build about a product’s safety.

Patient details

• Sex
• Age

Reporter details

• Name
• Contact details (name, address, phone number)

Product details

• Name of product
• What the product was taken or used for
• How the product was taken or used (swallowed, injected or applied; dose; how often)

Adverse event or side effect details

• What happened?
• Did you/they receive treatment for the side effect?
• Have you/they recovered?

We ask for contact details from people making reports so that we can ask for more information about suspected adverse events if needed. We cannot accept anonymous reports.

We collect a variety of personal information to process these reports.

Information about we handle personal information under the Privacy Act 1988 is in the Privacy section of our website.

If you're a sponsor of a medicine or biological, learn about your legal obligations for reporting adverse events at: Obligations to report adverse events for medicines and biologicals.