Report a side effect of a medicine
Thank you for reporting a side effect
Thank you for submitting a suspected side effect report. Your report has been received and forwarded to the TGA Pharmacovigilance and Special Access Branch.
Your report reference number is: .
Please quote it in any correspondence with the TGA about this report.
You can print a summary of the report details you have provided to the TGA.
What will happen to my report
The TGA enters every report we receive of a possible side effect to a medicine into a database, which we analyse to identify safety signals.
A safety signal might be a number of similar reports of an unexpected side effect with a particular drug and is a 'flag' for a possible safety issue with a medicine. We investigate safety signals in detail to work out the possible role of the medicine or vaccine in causing the side effect.
Three months after a report has been entered into the database, we make it publicly available in the Database of Adverse Event Notifications. The three month time lag allows us to check and analyse the information in the database.
We don't make any information public that could identify the reporter or the person who experienced the side effect.
|Fax||+61 2 6232 8392|
Therapeutic Goods Administration
For general privacy information, go to Privacy page on the TGA website.
Information in this report is collected to assist in the post-market monitoring of the safety of therapeutic goods under the Therapeutic Goods Act 1989 (the Act). All reports are assessed and entered into the Therapeutic Goods Administration’s (TGA’s) Australian Adverse Drug Reactions System (the ADRS). Further information about how the TGA reports on adverse event information is available on the TGA website.
The TGA collects personal information in this report to:
- Assess the safety of medicines and vaccines under the Act.
- Contact the reporter of the adverse event if further information is required.
- Contact representatives of entities that supply therapeutic goods, to discuss reported adverse events.
- Check that the same information has not been received multiple times for the same adverse event.
At times, this information is collected from someone other than the individual to whom the personal information relates. This can occur when an adverse event is reported to a person or an entity other than the TGA (such as a health professional or a hospital), and that person or entity passes the information on to the TGA.
Personal information collected in this report may be disclosed by consent or where the disclosure is required by, or authorised under, a law (for example, under section 61 of the Act). Where a report relates to vaccine events, personal information about the reporter or the patient may be disclosed to State and Territory health agencies under subsection 61(3) of the Act.