TGA removes Andrographis paniculata from the low-risk medicine ingredient list
Medicine Safety & Regulation | Australia
Australia’s medicines regulator has removed Andrographis from the ingredients permitted in low-risk listed medicines after concluding that warnings could not adequately manage the risk of severe allergic reactions.
Decision at a glance
Status
Removed from the Permissible Ingredients Determination.
Effective date
17 September 2026. The final notice was published on 18 September.
Immediate effect
New Andrographis medicines can no longer enter the low-risk listed-medicine pathway.
What changed?
The TGA, or Therapeutic Goods Administration, has removed Andrographis paniculata from the Permissible Ingredients Determination. This is the legal list of ingredients that may be used in low-risk listed medicines in Australia.[1]
From 17 September 2026, new medicines containing Andrographis are no longer eligible to be included as listed medicines in the ARTG, or Australian Register of Therapeutic Goods.[1]
Why did the TGA act?
Andrographis is used in some herbal products marketed for cold and flu symptoms or immune support. The TGA’s updated review concluded that anaphylaxis associated with these products can be severe, rapid and unpredictable. Anaphylaxis is a serious allergic reaction that requires emergency medical treatment.[3]
The regulator received 287 reports of anaphylaxis associated with Andrographis-containing medicines between 2005 and 31 December 2025. Of these, 217 were received from 2019 onwards. A fatal case associated with an Andrographis-containing product was reported in June 2024.[4]
The TGA had required allergy and anaphylaxis warnings on listed Andrographis medicines released for supply since May 2020. Its supplementary review found no decline in the sustained reporting pattern after warnings were strengthened on one prominent product in 2024.[4]
What the evidence says
Supported The TGA identified a continuing serious safety signal
The safety review considered Australian and international adverse-event reports, specialist advice, product formulations, published literature and toxicology. The TGA concluded that severe, unpredictable anaphylaxis remained associated with Andrographis despite existing risk controls.[3]
Uncertain The exact frequency of anaphylaxis cannot be calculated
Spontaneous adverse-event reports do not provide a reliable count of how many people used the products. Some reports were incomplete, and many involved multi-ingredient products. The data therefore cannot establish the precise incidence of anaphylaxis or prove causation in every report.[2]
Not supported Every Andrographis product was immediately banned or recalled
The decision does not instantly remove every existing product from sale. The TGA first recommended voluntary cancellations, cessation of supply and recalls. Compulsory cancellation or recall decisions will be considered for individual medicines if timely voluntary action does not occur.[1]
What remains uncertain?
Adverse-event reporting systems are designed to detect safety signals, not calculate precise risk. Reports may be incomplete, duplicated, stimulated by publicity or affected by under-reporting. They also cannot prove that an ingredient caused every reported reaction.
Most of the 287 Australian anaphylaxis reports involved products containing both Andrographis and Echinacea. However, 50 reports involved Andrographis products without Echinacea, including 15 involving single-ingredient products. After considering supply patterns, the TGA concluded that the signal could not be confined to Echinacea or to a particular formulation.[4]
The consultation outcome paper acknowledged the absence of robust exposure data and uncertainty about the true incidence. The regulator nevertheless concluded that the continuing pattern of severe reactions was incompatible with the expectations for a low-risk listed medicine.[2]
What happens to existing products?
The TGA has strongly recommended that sponsors take voluntary action. This may include cancelling affected ARTG listings, stopping manufacture and release of new stock, and arranging consumer-level recalls.[1]
If sponsors do not act promptly, the TGA says it will begin taking regulatory action from mid-October 2026. Any compulsory cancellation or recall will apply to specific medicines following consideration by the appropriate decision-maker.
This distinction matters. A product remaining on a shelf immediately after the decision does not mean that the TGA reversed its finding. It may reflect the transition from the ingredient-level decision to product-level action.
What did the consultation find?
The TGA received 29 submissions. Health professional organisations outside the complementary-medicine sector generally supported removal, citing the severity and unpredictability of anaphylaxis and the burden on emergency services.[2]
Industry groups, affected sponsors, complementary-medicine practitioners and related organisations were largely opposed. They argued that the reaction was rare, questioned aspects of the evidence, and preferred stronger warnings, formulation restrictions, education or practitioner-only access. Complementary Medicines Australia publicly described the decision as disproportionate.[6]
The TGA responded that no compelling evidence submitted during consultation overturned the review’s conclusion. It judged that warnings and other proposed controls would not adequately reduce the risk within the listed-medicine framework.[2]
Safety note
The TGA advises consumers to reconsider their need to take products containing Andrographis. People may still encounter these products while sponsors and the regulator consider further action.[1]
Possible signs of anaphylaxis include difficult or noisy breathing, tongue swelling, throat tightness, wheezing, difficulty speaking, persistent dizziness or collapse. Severe allergic symptoms require urgent medical attention. Call 000 if anaphylaxis is suspected.
Key sources
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| Source | What it found | Main limitations |
|---|---|---|
| TGA final decision, 2026 Official regulatory notice Read the decision |
Confirms removal from the Permissible Ingredients Determination, effective 17 September 2026, and explains the transition for existing products. | Describes a regulatory judgment. It is not a clinical trial and does not calculate the individual probability of a reaction. |
| TGA consultation outcome, 2026 29 submissions Read the outcome paper |
Summarises support, opposition, methodological criticisms and the regulator’s response before the final recommendation. | Consultation participation was uneven, with relatively few consumer and mainstream healthcare submissions. |
| TGA updated safety review, 2026 Regulatory safety assessment Read the safety review |
Found a sustained signal of serious, unpredictable anaphylaxis and assessed warning-based risk controls as inadequate for a low-risk listed ingredient. | Relies substantially on spontaneous adverse-event data, with incomplete reports and no precise population exposure denominator. |
| TGA supplementary report, 2026 Data updated to 31 December 2025 Read the supplementary report |
Reported 287 Australian anaphylaxis reports associated with Andrographis-containing medicines, including 217 since 2019. | Reports show association, not confirmed causation in every case, and cannot establish the exact incidence. |
Frequently asked questions
Has Australia banned every Andrographis product?
No. The confirmed decision removes Andrographis from the ingredient list used for low-risk listed medicines. Existing products are not all recalled automatically. Sponsors and the TGA must take further action for individual products.
Can shops still sell products containing Andrographis?
Some currently listed products may remain available during the transition. Their status may change if sponsors cancel listings or conduct recalls, or if the TGA orders product-specific action.
Why did the TGA remove Andrographis?
The regulator concluded that the continuing risk of severe and unpredictable anaphylaxis could not be adequately managed within the low-risk listed-medicine framework.
How many anaphylaxis reports were recorded?
The TGA supplementary report recorded 287 reports associated with Andrographis-containing medicines from 2005 to the end of 2025. Reports identify a safety signal, but they do not establish the exact reaction rate or prove causation in every case.
Does the decision show whether Andrographis works for colds?
No. This decision concerns safety and whether the ingredient is suitable for the low-risk listed-medicine pathway. It is not a clinical effectiveness review of Andrographis for cold or flu symptoms.