Reporting problems

The online medicine or vaccine side effect (adverse event) reporting forms are temporarily unavailable due to a planned system upgrade. You can still report adverse events to the TGA using one of the alternative methods detailed below.

Report

Reporting can include adverse events involving unapproved therapeutic goods accessed through the Special Access Scheme, as part of a clinical trial or accessed from an Authorised Prescriber.

For information about making a complaint, whether about a breach of the Therapeutics Goods Act, the TGA website or a service received from the TGA, see Contact the TGA.

More information on medicines

For further information about a specific prescription medicine, read the Consumer Medicine Information, which is freely and easily available through the TGA's MedSearch App.

You can also find a list of side effects that have already been reported to the TGA on the Database of Adverse Event Notifications (DAEN).

Email reports

Anyone can lodge a report with the TGA via email:

Contact details

Consumers wanting to report a side effect to a medicine or vaccine by telephone are encouraged to speak to a pharmacist from NPS Medicinewise on 1300 134 237. The pharmacist can both lodge the report and provide further advice on how to manage the side effect.

If you want to lodge a report about a defect with a medicine or vaccine, contact the TGA on 1800 020 653. Please note, TGA staff cannot provide clinical advice.

If you want to lodge a report about a problem with a medical device, phone 1800 809 361.

If you are telephoning us to report a problem, please call between 9am to 5pm, Monday to Friday.

If you have a hearing or speech impediment, find out more about the National Relay Service, or view our postal contact details.

Report

Reporting can include adverse events involving unapproved therapeutic goods accessed through the Special Access Scheme, as part of a clinical trial or accessed from an Authorised Prescriber.

For information about making a complaint, whether about a breach of the Therapeutics Goods Act, the TGA website or a service received from the TGA, see Contact the TGA.

More information on medicines

For further information about a specific prescription medicine, read the Product Information, which is freely and easily available through the TGA's MedSearch App.

You can also find a list of adverse events already reported to the TGA on the Database of Adverse Event Notifications (DAEN).

Email reports

Anyone can lodge a report with the TGA via email:

Contact details

If you want to lodge a report about an adverse event or a defect with a medicine or vaccine, contact the TGA on 1800 020 653.

If you want to lodge a report about a problem with a medical device, phone 1800 809 361.

If you are telephoning us to report a problem, please call between 9am to 5pm, Monday to Friday.

If you have a hearing or speech impediment, find out more about the National Relay Service, or view our postal contact details.

Report

Reporting can include adverse events involving unapproved therapeutic goods accessed through the Special Access Scheme, as part of a clinical trial or accessed from an Authorised Prescriber.

For information about making a complaint, whether about a breach of the Therapeutics Goods Act, the TGA website or a service received from the TGA, see Contact the TGA.

More information on medicines

You can also find a list of adverse events already reported to the TGA on the Database of Adverse Event Notifications (DAEN).

Email reports

Anyone can lodge a report with the TGA via email:

Contact details

If you want to lodge a report about an adverse event or a defect with a medicine or vaccine, contact the TGA on 1800 020 653.

If you want to lodge a report about a problem with a medical device, phone 1800 809 361.

If you are telephoning us to report a problem, please call between 9am to 5pm, Monday to Friday.

If you have a hearing or speech impediment, find out more about the National Relay Service, or view our postal contact details.

More information on reporting

For further information about reporting, including what type of details should be included in a report and what will happen to a report once received, see the TGA's reporting adverse events overview and frequently asked questions section.

Black Triangle Scheme

The Black Triangle Scheme provides a simple way for health practitioners and patients to identify certain types of new prescription medicines, and to encourage the reporting of side effects associated with their use.