The Risks of Andrographis and the TGA’s New Safety Measures
Andrographis, a herb commonly found in cold and flu supplements, may no longer be considered a “low-risk” ingredient. This is due to concerns raised by Australia’s Therapeutic Goods Administration (TGA), which has identified serious risks associated with its use, including severe allergic reactions and even death.
The TGA is now proposing to remove andrographis from its list of permitted ingredients in herbal medicines. A recent safety review highlighted that the herb can cause anaphylaxis — the most severe form of allergic reaction — which can occur suddenly and without warning, even if someone has previously taken it without issues. Despite its widespread use in traditional Indian and Chinese medicine, there is still limited scientific evidence supporting its effectiveness for treating colds, flu, or other ailments.
What is Andrographis?
Andrographis paniculata is a flowering plant in the Asterids clade, often used to treat symptoms like colds, upper respiratory tract infections, inflammation, and fever. It is particularly popular in Western societies, especially following the COVID-19 pandemic, as more people turn to natural remedies.
In Australia, andrographis is frequently combined with echinacea. In 2024, the TGA reported that over 80% of adverse event reports involved multi-ingredient products containing both andrographis and echinacea. Both ingredients have been linked to anaphylaxis, raising further concerns about their safety.
Why Did the TGA Conduct This Review?
All medicines are monitored for adverse effects, and andrographis has long been associated with allergic responses. The TGA first began receiving reports of anaphylaxis related to andrographis in 2005. By 2015, the agency issued a public alert after finding that the herb could cause life-threatening allergic reactions.
Anaphylaxis is a medical emergency that can lead to swelling of the throat, difficulty breathing, and even death if not treated promptly. While such reactions are rare, they are highly concerning due to their severity and unpredictability.
Changes to Labelling and Availability
In 2019, there was a sudden increase in adverse events linked to andrographis. This prompted the TGA to update the safety warnings on products containing the herb. A new label was introduced, stating:
“Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention.”
This updated labelling was implemented between December 2019 and May 2020. However, despite these changes, the TGA recorded another spike in adverse events in May 2020, coinciding with the early stages of the COVID-19 pandemic. Although few cases of the virus were reported in Australia at the time, many of the adverse events included symptoms like loss of taste and smell — typically associated with the virus.
Industry groups responded by making additional voluntary changes, such as placing andrographis-containing products behind the pharmacy counter, requiring consultation with a pharmacist before purchase.
Further Spikes in Allergic Reactions
Despite these measures, there were significant spikes in allergic reactions involving andrographis in 2022, 2023, 2024, and 2025. Tragically, in June 2024, the TGA received a report of a fatality caused by anaphylaxis after taking andrographis. Another case involved drug-induced liver injury.
The reasons why andrographis causes anaphylaxis remain unclear. Most affected individuals had no prior history of allergies or asthma, highlighting the unpredictable nature of the reaction.
What Does the TGA Recommend Now?
The TGA has determined that previous measures — such as updated labels and restricted availability — have not significantly reduced the occurrence of serious adverse reactions. As a result, the agency has proposed removing andrographis from its list of permitted ingredients in listed medicines.
The TGA has opened a consultation period with stakeholders, including consumer groups, health professionals, and industry representatives. During this time, consumers are advised to review the TGA’s updated safety review and supplementary report available on its website before using any product containing andrographis.
How to Stay Safe
If you or someone else experiences anaphylactic symptoms, seek emergency medical help immediately by calling triple zero (000). For other allergic reactions, stop taking the product and consult a healthcare professional.
Always speak to a health professional before starting any new medication, including herbal supplements. Read the label carefully, even if the product does not require a prescription.
