The TGA’s decision to remove Andrographis paniculata from the ingredients permitted in new Listed medicines is an important development for herbal practitioners. Below, you’ll find a brief summary of the decision and the NHAA’s response, followed by two documents with further detail and answers to common questions.
Andrographis removed from the TGA Listed medicines framework
On 17 September 2026, the TGA removed Andrographis paniculata from Listed medicines following more than 1,300 adverse event reports, including anaphylaxis and a fatality in 2024.
In summary:
- Across all preparations: The TGA review didn’t identify any dose, extract or preparation type, including liquid extracts, with a lower risk profile.
- Hard to predict: Reactions have occurred in people who previously took Andrographis without issue, and standard allergy screening may not identify those at risk.
- Supporting your patients: It’s worth reviewing current protocols and stock, talking through any concerns with patients, documenting informed consent, and reporting any suspected adverse events to the TGA.
What the NHAA is doing: We made a submission to the TGA review and continue to work with the TGA and industry. We are seeking clarification on practitioner-dispensed preparations, liaising on supply and recalls, and developing member resources and CPD on pharmacovigilance.
Please read the overview below.
Here is the link to downloading our Q&A
Andrographis paniculata has been removed from the TGA listed medicines framework
Overview
On 17 September 2026, the Therapeutic Goods Administration (TGA) announced the removal of Andrographis paniculata (Andrographis) from the list of permissible ingredients for Listed medicines in Australia. As a result, new Andrographis-containing products can no longer be supplied through the Listed medicines pathway, unless they undergo the more rigorous Registered medicine approval process.
The TGA has also strongly encouraged companies to voluntarily cancel existing Andrographis-containing products from the Australian Register of Therapeutic Goods (ARTG), cease further manufacture and distribution, and consider product recalls where appropriate.
This decision follows a series of safety reviews conducted since 2015 and more than 1,300 reported adverse events associated with Andrographis-containing products, including a significant number of anaphylactic reactions. According to the TGA, investigations have not identified any particular dosage form, extract type, formulation, or manufacturer that is associated with a lower risk profile. Existing risk-mitigation measures, including mandatory warning statements introduced in 2020 and enhanced warning labels adopted by some sponsors, have not been sufficient to reduce the reported incidence of serious adverse reactions.
The NHAA encourages all members to familiarise themselves with this important regulatory development and consider its implications for clinical practice, product recommendations, dispensary stock, and patient communication. This decision highlights the importance of ongoing pharmacovigilance and the professional responsibility of practitioners to monitor, document, and report adverse events associated with complementary medicines.
Many practitioners may have patients currently using Andrographis-containing products or seeking advice regarding the TGA’s decision. It is therefore important to provide balanced, evidence-informed guidance, acknowledge patient concerns, and consider suitable therapeutic alternatives where clinically appropriate.
This document provides NHAA members with an overview of the regulatory decision, the safety concerns underpinning the TGA’s action, practical considerations for clinical practice, guidance for responding to patient enquiries, and information on potential herbal alternatives that may be considered based on individual patient needs.
Background and History of Safety Concerns
Concerns regarding the safety of Andrographis-containing products have been under review by the TGA for more than two decades. The TGA first received reports of anaphylaxis associated with Andrographis-containing medicines in 2005 and commenced further investigation following additional safety signals identified in 2008. In 2015, the TGA published a safety review and consumer advisory highlighting reports of anaphylactic and other serious allergic reactions linked to products containing Andrographis.
Following a notable increase in adverse event reports during 2019, the TGA introduced mandatory warning statements for listed medicines containing Andrographis. Since May 2020, these products have been required to carry warnings advising consumers that allergic reactions may occur and that use should be discontinued immediately if severe reactions, including anaphylaxis, are experienced.
Despite these regulatory measures and ongoing post-market surveillance, reports of serious allergic reactions continued to be received. A fatal adverse event reported in 2024 triggered a further review of the available safety data. Additional risk-management strategies, including enhanced warning labels adopted by some sponsors, did not appear to significantly reduce the frequency of reported reactions. Consequently, the TGA concluded that existing warning and education measures were insufficient to adequately manage the risk.
The TGA’s review identified several factors contributing to concern. Serious allergic reactions associated with Andrographis may occur rapidly, can be severe, and are difficult to predict. Importantly, many individuals who experienced anaphylaxis had previously taken Andrographis without any adverse effects, indicating that prior tolerance does not guarantee future safety. Most reactions occurred within a short period following ingestion, with a substantial proportion requiring emergency medical treatment and hospitalisation.
The review also found that common screening approaches, such as assessing a patient’s history of asthma, allergies, or previous reactions, were unlikely to identify many individuals at risk. In addition, factors such as acute viral illness, exercise, alcohol consumption, and the concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase either the likelihood or severity of an allergic reactions. This observation is particularly relevant given that Andrographis is most commonly used during periods of viral infection, which may further complicate risk assessment.
For herbal medicine practitioners, the TGA’s findings highlight the importance of remaining informed about evolving safety data, undertaking careful risk-benefit assessments, and maintaining robust pharmacovigilance practices. The unpredictability of these reactions reinforces the need for practitioners to educate patients about
potential adverse effects, encourage prompt reporting of any suspected reactions, and contribute to ongoing monitoring of medicine safety through adverse event reporting systems.
Preparations and Liquid Extracts
A key finding of the TGA review was that no particular preparation form of Andrographis could be considered demonstrably safer than another. The available evidence did not identify any consistently lower-risk dose, extract strength, extraction method, plant part, manufacturer, formulation, or andrographolide concentration. Reports of anaphylaxis and other serious allergic reactions were associated with a broad range of Andrographis-containing products and preparation types.
Of particular relevance to herbal medicine practitioners, the review included a reported case of anaphylaxis following the use of a traditional liquid herbal extract. This finding challenges the assumption that liquid preparations may carry a lower risk than tablets, capsules, or standardised extracts. Based on the evidence examined, the risk of serious allergic reactions does not appear to be limited to any specific dosage form.
For practitioners, this means that product selection based on preparation type alone cannot be relied upon as an effective risk-reduction strategy. The TGA concluded that serious allergic reactions may occur across the spectrum of Andrographis products currently available, reinforcing the rationale for the regulatory action and the importance of discussing these risks with patients when reviewing previous or current use of Andrographis-containing medicines.
What Does This Mean for NHAA Members?
The TGA’s decision to remove Andrographis paniculata from the permissible ingredients list has several practical implications for herbal medicine practitioners.
1. Clinical prescribing and recommendations: Members should carefully review any current treatment protocols, dispensary formulations, or patient recommendations that include Andrographis. Given the TGA’s conclusion that serious allergic reactions can occur across different preparations, including traditional liquid extracts, practitioners should avoid assuming that one form of Andrographis is safer than another.
2. Patient communication: Many patients may become aware of media coverage or product withdrawals and seek advice from their practitioner. Members should be prepared to explain that the regulatory action is based on concerns regarding rare but potentially severe and unpredictable allergic reactions, including anaphylaxis. Patients currently taking Andrographis should be encouraged to discuss their individual circumstances with their healthcare practitioner before making changes to their treatment plan.
3. Dispensary and stock considerations: Practitioners who dispense herbal medicines should review existing Andrographis-containing products and remain informed of any actions taken by companies, manufacturers, wholesalers, or pharmacies regarding supply, cancellation, or recall of products. Members should ensure they are using products that remain compliant with current regulatory requirements.
4. Risk assessment and informed consent: The TGA review found that previous tolerance to Andrographis does not reliably predict future safety and that conventional screening for allergy risk may not identify susceptible individuals. This reinforces the importance of discussing potential risks and benefits with patients and documenting informed clinical decision-making.
5. Pharmacovigilance responsibilities: This regulatory action highlights the critical role practitioners play in medicine safety monitoring. NHAA members are encouraged to actively document, monitor, and report suspected adverse events associated with complementary medicines through the TGA adverse event reporting system. Timely reporting contributes to the evidence base used to assess the ongoing safety of therapeutic products.
6. Consider alternatives: Where Andrographis has traditionally been used for immune support or the management of upper respiratory tract infections, practitioners may wish to consider alternative evidence-informed herbal medicines based on the patient’s presentation, health status, medications, and therapeutic goals. Selection of alternatives should reflect individual clinical circumstances rather than a direct substitution approach.
7. Maintaining professional currency: Finally, this decision serves as an important reminder of the professional responsibility to remain up to date with changes in therapeutic goods regulation, emerging safety data, and evolving best-practice standards. Ongoing engagement with professional development, regulatory updates, and pharmacovigilance helps ensure safe, effective, and evidence-informed patient care.
September 2026