Joint Association Statement Andrographis paniculata for practitioners

27^th Oct 2026

Joint Association Statement Andrographis paniculata for practitioners

Andrographis paniculata has been identified as a herb with an unpredictable safety risk and has been removed as an available ingredient permitted for use in new listed medicines by the TGA. Its removal is on the basis that severe allergic reactions, including anaphylaxis, may occur unpredictably, including in individuals who have previously used the herb without experiencing a reaction.

While the frequency of these reactions is not precisely known, available evidence indicates that a safe dose or preparation of Andrographis paniculata has not been established. It is currently unclear whether the risk differs between various administration forms or methods of preparation (i.e. tablets, capsules, powder or liquid herbal extracts).

Importantly, the TGA’s decision relates specifically to the listed medicines framework and does not constitute a blanket prohibition on the use of Andrographis paniculata. While new medicines containing this ingredient can no longer be listed on the ARTG, other lawful pathways remain available, including the registered medicines pathway and, where applicable regulatory requirements are met, practitioner dispensing or extemporaneous compounding for individual patients. Practitioners should check the regulatory status of individual products, including any applicable recalls, and exercise appropriate professional judgement when considering the use of Andrographis, taking into account the identified safety risks.

Please consider and seek advice from your professional indemnity and product liability insurance provider about your cover for prescribing, compounding or supplying Andrographis paniculata, as applicable.

If you have any questions, reach out to your association.

• Download PDF