Source: The Conversation (Au and NZ) – By Ian Musgrave, Senior Lecturer in Pharmacology, Adelaide University
A herb commonly sold in cold and flu supplements may no longer be classified as “low-risk”, after Australia’s therapeutic goods regulator found it can cause severe allergic reactions and even death.
The Therapeutic Goods Administration (TGA) is proposing to remove andographis – widely used in Indian and Chinese traditional medicine – from its list of permitted ingredients. A new safety review found the herb can cause “rapid and unpredictable” anaphylaxis, the most severe type of allergic reaction.
Anaphylaxis can happen even if you’ve previously taken andrographis without any problems. But little is known about why.
Currently, products containing this ingredient can be purchased at supermarkets and pharmacies without a prescription.
Here’s what we know about the risks, and what the TGA wants to change.What is andrographis?
Traditional medicines are becoming more popular in Western societies, particularly in response to the COVID pandemic.
Andrographis paniculata is one of these: a herb in the Asterids clade of flowering plants. Andrographis is often used to treat and prevent cold and flu symptoms, upper respiratory tract infections, inflammation and fever.
However, despite its popularity, there is a gap in empirical evidence to support these benefits.
In Australia, andrographis is ofen used in combination with another herbal ingredient, echinacea. In 2024, the TGA said more than 80% of the adverse event reports it received were for multi-ingredient preparations that included both andrographis and echinacea, which has also been linked to anaphylaxis.
Why did the TGA conduct this safety review?
All medicines are surveyed for adverse events, and andrographis is known to be associated with allergic responses.
The TGA first began receiving reports of anaphylaxis and hypersensitivity in 2005, from people who’d taken andrographis.
In 2015, the TGA published a public alert after a safety review found andrographis can cause serious allergic reactions, including anaphylaxis.
Anaphylaxis can be fatal if not treated immediately. Anaphylactic reaction to a trigger (such as food, medication or insect bites) can cause symptoms including swelling of the tongue and throat, and difficulty breathing.
So, while rare, allergic reactions to andrographis are concerning because they can be life-threatening.
Changes to labelling
In 2019 there was a sudden rise in adverse effects reported, with a large number of allergic and anaphylatic reactions. This led the TGA to change safety messaging on medicines containing andrographis. A warning was added to the label:
Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention.
The new, mandatory labelling was rolled out between December 2019 and May 2020.
Despite this labelling, the TGA recorded another spike in reported adverse events from May 2020. This increase coincided with first months of the COVID pandemic, although there were few COVID cases in Australia at that time.
This particular rise in adverse events was associated with a loss of sense of taste and smell, symptoms associated with COVID, although these people did not have COVID. Allergic and anaphlyactic responses were also reported.
Industry groups responded with further voluntary labelling changes. Some also decided to put preparations containing andrographis behind the pharmacy counter, so people would need to consult with a pharmacist before using them.
Further spikes in allergic reactions
Even with these new labelling and availability approaches, there were significant adverse event spikes in 2022, 2023, 2024 and 2025, involving significant numbers of allergic reactions.
Tragically, in June 2024 the TGA received a report that someone had died from anaphylaxis after taking andrographis. Another case involved drug-induced liver injury.
While there are other serious reactions to andrographis, the anaphylactic reactions are considered the most serious as these are life-threatening, unpredictable and usually progress rapidly. Symptoms usually began within 30 minutes.
It is not clear why andrographis causes anaphylaxis. Most people affected had no history of allergies or asthma.
What does the TGA recommend now?
Previous changes – to labelling, and putting the products behind the pharmacist’s counter – have not substantially altered the incidence of serious adverse reactions.
So the TGA has proposed to remove andrographis from its list of permitted ingredients. These are low-risk ingredients that are permitted in listed medicines, including herbal preparations.
The TGA has opened a consultation about this proposal with stakeholders, such as consumer associations, health professionals, medicine sponsors and industry peak bodies.
In the meantime, consumers should read the TGA’s updated safety review and supplementary report website before taking any medicine that contains andrographis.
How else to stay safe
If you believe you or someone else is having an anaphylactic reaction, seek emergency medical help immediately by calling triple 0.
And if you experience any other symptoms of an allergic reaction, stop taking the product and seek medical advice.
You should always speak to a health professional before taking any medication, including herbal supplements, and read the label before using a product – even if you buy it without a prescription.
– ref. What is andrographis, the cold and flu ingredient the TGA says can be fatal? – https://theconversation.com/what-is-andrographis-the-cold-and-flu-ingredient-the-tga-says-can-be-fatal-280356
