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10 questions: reporting side effects

17 October 2018

What are side effects?

A side effect is anything that goes wrong when you use a medicine or medical device.  We call them “adverse events”.

Why report side effects?

It helps us monitor the safety of medicines and medical devices.

What should I report?

Report as much information as you can on all of the side effects that you think might be related to use of the medicine or medical device.

Even already known side effects?

Yes, those too.  Report all side effects.

So, what will you do with this report?

Each report feeds into the data we use to spot patterns and potential problems. So every report counts!

And what if you find a problem?

The TGA will take appropriate regulatory action in cases where it is warranted.  For example, a defective medical device could be recalled.

How do I report?

You can report side effects by filling in a form on the TGA website reporting problems page. You can also ask your doctor to make a report on your behalf.

Reports are private, right?

Side effects are recorded in a public database, but all identifying personal information is confidential.

Can I report someone else’s side effect?


Should I consult a health professional as well?

Yes. Any side effects should be raised with a health professional such as a doctor.