If you have an unexpected or severe reaction to a prescription medicine, an over-the-counter drug, or a medical device in Australia, telling your GP isn't the only step that matters. Australia's medicine safety net relies on a centralised reporting system run by the Therapeutic Goods Administration (TGA) — and both health professionals and everyday consumers can report directly.
Why reporting matters beyond your own case
Reports feed the Database of Adverse Event Notifications (DAEN), which the TGA uses to spot early warning signs — a contaminated batch, a labelling failure, or an undeclared side effect — that can lead to a product being pulled from sale.
What's covered
The TGA's remit covers prescription medicines, complementary medicines (vitamins and herbal supplements), vaccines, regulated sunscreens, and medical devices from everyday items like glucose monitors to implantable devices like pacemakers.
What to have ready before you report
Note the full brand name, the active ingredient, the batch or lot number (printed on the box or blister pack), and a clear timeline of when your symptoms started relative to taking or using the product.
Submitting your report
Reports go through the TGA's online reporting portal. TGA staff assess the case, and where a statistical signal emerges around a specific batch, the TGA can issue a national Safety Alert requiring pharmacies to pull the affected stock.