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Report an adverse event or problem (consumers)
The TGA collects adverse event reports to monitor the safety of medicines and medical devices, but we cannot provide you with healthcare or health advice.
You may experience outages and temporary issues related to medical devices adverse event reporting and access to the Database of Adverse Event Notification (DAEN) - medical devices due to scheduled maintenance around 10am-12pm AEST on 25 August and 1 September 2023.
You can report:
- medicine or vaccine side effects (adverse events)
- medical device adverse events
- counterfeit products
- issues with medicine packaging or storage.
If you think you may be experiencing a side effect to a medicine or a problem with a medical device, seek advice from a health professional as soon as possible.
Medicine or vaccine side effects (adverse events)
There are three ways you can report a medicine or vaccine side effect (adverse event): over the phone, online, or by email.
Report over the phone
Call the Adverse Medicine Events (AME) line on 1300 134 237 to report a medicine or vaccine side effect over the phone. You will speak with a health professional who will lodge your report and can provide advice on how to seek help managing the side effect. This service is for medicines only.
Complete the online form to report a medicine or vaccine side effect.
Report by email
Email the TGA to report a medicine or vaccine side effect. Your email should include:
- your contact details
- a description of the side effect (what happened, when it happened and how long it lasted)
- a description of the medicine or vaccine you think caused the side effect (including any other medicines or medical devices you are using).
Medical device adverse events
Complete the online form to report a problem with a medical device.
Additional information on reporting medical device adverse events and frequently asked questions can be found at: Medical device incident reporting & investigation scheme (IRIS).
If you require assistance to report a medical device problem, call 1800 809 361 (08:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au
Complete the online form to report a counterfeit medicine or medical device.
Issues with medicine packaging or storage
Complete the online form to report an issue with a medicine's packaging or storage.