Adverse drug reactions: what to report

You do not need to be certain, just suspicious!

Any information related to the reporter and patient identifiers is kept strictly confidential.

Adverse drug reaction reports should be submitted for the following medicines:

• Prescription medicines (including vaccines)
• Over-the-counter medicines (medicines purchased without a prescription)
• Complementary medicines (herbal medicines, naturopathic and/or homoeopathic medicines, and nutritional supplements such as vitamins and minerals).

ADRAC particularly requests reports of:

• All suspected reactions to new medicines
• All suspected reactions to Drugs of Current Interest listed in the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm>
• All suspected drug interactions
• Unexpected reactions, ie not consistent with product information or labelling
• Serious reactions which are suspected of significantly affecting a patient's management, including reactions suspected of causing:
  • death
  • danger to life
  • admission to hospital
  • prolongation of hospitalisation
  • absence from productive activity
  • increased investigational or treatment costs
  • birth defects