Adverse drug 
reaction report to the Therapeutic Goods Administration (TGA)    

This report can be emailed to ADR.Reports@tga.gov.au as a Word or PDF document (preferred) or
faxed to 02 6232 8392.

<<Miscellaneous:Date>> 

Patient Identifier (Patient initials only): <<Patient identifier>>
Date of birth: <<Patient Demographics:DOB>>
Age: <<Patient Demographics:Age>>
Sex: <<Patient Demographics:Gender>>
Ethnicity: <<Patient Demographics:Ethnicity>>

Suspected drug(s) : <<Suspected drugs>>
Commencement date	Trade name	Dose	Route of administration	
<<Commencement date suspect drug 1>>	<<Trade name suspect drug 1>>	<<Dose suspect drug 1>>	<<Route of administration suspect drug 1>>	
<<Commencement date suspect drug 2>>	<<Trade name suspect drug 2>>	<<Dose suspect drug 2>>	<<Route of administration suspect drug 2>>	

Current medications:
<<Clinical Details:Medication List>>

ADR Narrative:<<ADR Narrative>>
Onset date of reaction	<<Onset date of reaction>>	
Patient symptoms	<<Patient Symptoms>>	
Severity	<<Severity>>	
Treatments (if applicable)	<<Treatments (if applicable)>>	
Outcome	<<Outcome>>	
Sequelae	<<Sequelae>>	
Other relevant information	<<Other relevant information>>	

Observations (Weight, height etc as required): 
<<Clinical Details:Measurements>>

Allergies:
<<Clinical Details:Allergies/Adverse Reactions>>

Past Medical History:
<<Clinical Details:History List>>

Social History:
<<Clinical Details:Social History>>

Yours faithfully,

<<Doctor:Name>>
<<Doctor:Qualifications>>
<<Practice:Address>>
<<Practice:E-mail>>
<<Practice:Phone>>
Privacy statement

For general privacy information, go to https://www.tga.gov.au/privacy.
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) Adverse Event Management System (the AEMS). Further information about how the TGA uses adverse event information that is reported to it is available at https://www.tga.gov.au/reporting-adverse-events
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.