1 March 2023

Pholcodine cough medicines cancelled by the TGA

Fifty-five cough medicines – all containing pholcodine – have been cancelled from the Australian Register of Therapeutic Goods.

Of the 55 products, there are 44 products still on pharmacy shelves that are now subject to recall following a safety investigation by the Therapeutic Goods Administration (TGA).

The investigation followed a link being found between pholcodine-containing medicines and an increased risk of anaphylactic reactions to some of the medicines used as muscle relaxants (neuromuscular blocking agents) during general anaesthesia.

Pholcodine is used in a range of over the counter pharmacy medicines to treat dry cough, particularly in syrups and lozenges.

It is also used in combination with other medicines in products that treat the symptoms of cold and flu.

The TGA’s advice for people who need general anaesthesia and who have taken pholcodine in the past 12 months, is to make your health professional aware.

Health professionals should also check whether patients scheduled to undergo general anaesthesia have used pholcodine in the previous 12 months.

See the TGA media release for more information and the full list of cancelled products here.