A herbal ingredient in popular cold and flu supplements will be pulled from pharmacy shelves after years of reports linking it to severe and sometimes fatal allergic reactions.
Following extensive safety and stakeholder review, the Therapeutic Goods Administration (TGA) has made the decision to remove Andrographis paniculata from the Therapeutic Goods (Permissible Ingredients) Determination, effective 17 September 2026.
Around 80 listed medicines currently contain the herb, with most marketed as cold, flu and immune-support products.
AP breaks down the reasons beyond the decision, what products are affected and what pharmacists need to tell patients.
Why is Andrographis being pulled?
As previously reported in AP, a TGA safety review recorded 287 reports of anaphylaxis linked to Andrographis-containing medicines since 2005 – including a fatal case reported in June 2024.
Several interventions, including a mandated warning label in 2019, failed to have an impact.
‘In 2024, we published a safety alert and one medicine sponsor added a stronger and more prominent warning label as a further safety measure. These measures have not led to a meaningful reduction in the number of reports of anaphylaxis,’ the TGA said.
The TGA’s safety review also found reactions to Andrographis are unpredictable. Adverse reactions can happen the first time someone takes it, and most people affected had no prior history of allergies or asthma – a profile that undermines strategies relying on patients to self-screen for risk.
Beyond the anaphylaxis reports, the TGA logged 1,368 adverse event reports up to 31 December 2025 linked to Andrographis-containing medicines, including ageusia and dysgeusia.
Connie Katelaris, Professor of Immunology and Allergy at Western Sydney University, said immunologists have long been aware of the risks Andrographis poses, and had previously raised concerns with the TGA.
‘Myself and my colleagues have seen many cases now of people who have ingested this on the promise that it helps to boost their immune system and help [sic] them fight off particularly respiratory infections,’ she said.
‘We’ve had several cases of patients having the most severe form of allergic reaction, that is anaphylaxis … and these are just the people who come forward to specialists.’
What products are affected?
BioCeuticals’ ArmaForce – sold in 30, 60 and 120-tablet packs – is a prominent cold and flu product containing Andrographis, alongside the same manufacturer’s Clinical Immune Force and Swisse’s Ultiboost Immune Action.
The vast majority of the 80 Andrographis-containing products are sold as combination formulas. More than 80% of reported adverse events involved Andrographis paired with Echinacea species, an ingredient with its own recognised history of anaphylaxis.
What’s the timeline for change?
From 17 September 2026, new medicines containing Andrographis are no longer eligible for listing on the Australian Register of Therapeutic Goods (ARTG). Medicines already listed won’t be pulled immediately. But the TGA has ‘strongly encouraged’ sponsors to voluntarily cancel their ARTG entry, work with manufacturers to cease manufacturing and release of stock, or undertake a consumer-level recall.
If sponsors don’t take action voluntarily, the TGA said it will begin regulatory action, including compulsory recalls or ARTG cancellations, from mid-October 2026.
In a statement, BioCeuticals said it has already begun this process.
‘We have ceased releasing stock for supply and are engaging with the TGA as a priority on the appropriate next steps for affected products including voluntary withdrawal from the market, in line with the TGA’s guidance.’
But the herb isn’t banned outright. Any product containing Andrographis will now require individual TGA assessment of safety, quality and efficacy through the registered medicines pathway.
What should pharmacists tell patients?
The TGA has instructed health professionals, including pharmacists, to be aware that reactions may happen on first use or after previous use without problems – and that they often occur within 30 minutes of taking the product.
While the evidence around why Andrographis causes anaphylaxis is limited, factors that can increase the risk or severity of allergic reactions include:
- viral infections
- anti‑inflammatory medicines use (like ibuprofen)
- alcohol use
- exercising around the time of exposure.
Should pharmacists be aware of a suspected Andrographis-releated adverse event, it should be reported to the TGA.
Pharmacists can learn more about reporting adverse events by completing the CPD activity ‘Pharmacovigilance and Therapeutic Risk Management’, coming soon to PSA’s Education Catalogue.
