News
An RACGP expert has welcomed a TGA proposal to remove Andrographis as a permitted ingredient in listed medicines.
Anaphylaxis associated with Andrographis can be ‘rapid and unpredictable’, the TGA warns.
The Therapeutic Goods Administration (TGA) has proposed the removal of Andrographis paniculata (Andrographis) from a list of permitted ingredients in listed medicines, following ongoing reports of anaphylaxis.
Andrographis is found in a range of herbal medicines for relief of colds and flu, and as a listed medicine, it can be purchased at pharmacies, supermarkets and health food stores without a prescription.
However, the ingredient has come under close watch from the TGA following concerns over anaphylaxis, with a safety review undertaken in 2015 and a requirement in 2019 for medicines containing Andrographis to carry a warning label for risk of allergic reaction.
Now, an updated safety review released by the TGA suggests that despite steps to increase safety, the regulator has ‘continued to receive a sustained number of reports of anaphylaxis associated with Andrographis‑containing medicines, with no indication of a declining trend’.
As of 31 December 2024, the TGA said it had received reports of 1217 adverse events related to medicines containing Andrographis. And in latest figures up to 31 December 2025, there had been 287 reports of anaphylaxis, including one fatal case in 2024.
Of further concern is that anaphylaxis associated with Andrographis can be ‘rapid and unpredictable’ – it can occur on first use or after previous uneventful use, even in people with no history of allergies.
‘Symptoms can appear within 30 minutes of taking the medicine and often require urgent medical treatment,’ the safety review states.
The TGA states that for an ingredient to remain appropriate for use in low-risk listed medicines available from retail outlets, ‘it should be safe for self-administration without the need for medical advice or supervision’.
‘As the risk of life-threatening anaphylaxis cannot be predicted or reliably mitigated, and with a sustained high number of reports of anaphylaxis involving Andrographis-containing listed medicines since 2019, this ingredient is inconsistent with the low-risk medicines regulatory framework.’
The idea of introducing stronger label warnings, formulation restrictions or further education was rejected by the TGA review as effective options to reduce the risk.
‘This updated safety review has concluded that even if additional risk mitigation strategies were adopted, the risk of life-threatening anaphylaxis associated with Andrographis is inconsistent with the low-risk regulatory framework of listed medicines.’
Chair of the RACGP Expert Committee – Quality Care, Professor Mark Morgan supports the TGA’s proposal.
‘With any medication decision there is always a balance of harms or risks against benefits. The evidence of benefits for Andrographis to relieve cold and flu symptoms is limited,’ he told newsGP.
‘I agree with the TGA’s approach to remove Andrographis from permitted ingredients.’
Professor Morgan also suggested GPs be aware of the concerns around Andrographis.
‘If a patient describes anaphylaxis symptoms, this awareness might help the hunt for a trigger for the symptoms,’ he said.
A spokesperson for the TGA also recommended GPs help patients understand the risks of taking products containing Andrographis and advise patients accordingly. This includes educating patients on the signs of anaphylaxis as well as what to do if an allergic reaction occurs.
As well as a rapid onset of symptoms, it is important to note that ‘a viral illness can increase the likelihood or severity of an allergic reaction,’ the spokesperson said.
‘Consumers and health professionals are also encouraged to report any suspected problems with Andrographis, as this will assist with the TGA’s monitoring of these products.’
The TGA has invited stakeholders, including patient associations, health professionals, medicine sponsors and industry peak bodies to provide feedback on the proposed removal of Andrographis from the permitted ingredients list.
Updated safety advice can be access via the TGA website.
Log in below to join the conversation.
anaphylaxis Andrographis medicine safety medicines regulation TGA Therapeutic Goods Administration
newsGP weekly poll
How important is mentoring in supporting GPs throughout their career?