The move follows reports of anaphylaxis - a severe allergic reaction which may be potentially life-threatening. Symptoms include swelling of the throat and tongue, difficulty breathing, swallowing, wheezing, and blue, grey or pale skin.
Andrographis, on the other hand, can be found in a range of herbal medicines intended to relieve cold and flu. Such products can be purchased in Australia without a prescription at pharmacies, supermarkets and health food stores.
A search on the Australian Register of Therapeutic Goods (ARTG) shows 84 results on Andrographis products. Most of these products claim to support immune health.
Number of cases
As of December 31, 2025, the TGA has received 287 reports of anaphylaxis associated with Andrographis-containing medicines. The regulator received its first such report in 2005.
Notably, the majority of the cases - 217 or 76% of them - were received between 2019 and 2025. A spike was also observed in 2024, where 53 cases were reported. The TGA said this could be due to increased awareness as a result of ongoing public education during that time.
In 2025, the number of cases was 33, consistent with that of 2022 and 2023, when 33 and 30 cases were reported, respectively.
“The sustained high reporting since 2019 supports the conclusion of the Andrographis updated safety review, that current risk mitigation measures have not reduced the risk of anaphylaxis associated with Andrographis for it to be suitable for inclusion as an ingredient in listed medicines,” the TGA wrote in its adverse event report on Andrographis paniculata and anaphylaxis.
Single ingredient and formulated products implicated
Overall, reports of anaphylaxis were associated with 48 Andrographis products. Of which, five were from a particular company and contained the same ingredient formulation and tradename. These five products were involved in 66% of the anaphylaxis cases.
Interestingly, 83% of all anaphylaxis reports involved products containing both Andrographis and Echinacea.
Against this backdrop, the regulator clarified that Echinacea is not the primary causative factor in anaphylaxis adverse events observed in Andrographis-containing medicines.
One reason is that only 10 anaphylaxis cases involving medicines containing Echinacea without Andrographis have been reported to the TGA.
“International reporting reveals disproportionately high reporting of anaphylaxis associated with Andrographis, and at a level that is greater than that for Echinacea,” the TGA wrote.
The remaining 12% of anaphylaxis reports involved multi-ingredient Andrographis-containing medicines that did not contain Echinacea, and the rest (5%) contained Andrographis as a single active ingredient.
“Anaphylaxis associated with Andrographis can be rapid and unpredictable. It can occur on first use or after previous uneventful use, even in people with no history of allergies,” the TGA wrote. “Symptoms can appear within 30 minutes of taking the medicine and often require urgent medical treatment.”
Would a label warning work?
Based on experience, the TGA pointed out that a label warning is unlikely to reduce the number of anaphylaxis cases.
Citing the case of a product where stronger and prominently displayed label warnings were introduced in 2024, the TGA said that the number of anaphylaxis reports for this product in 2025 was consistent with 2022 and 2023 before the label warning was introduced.
“This further supports the conclusion of the Andrographis updated safety review, that available evidence does not support that a stronger label warning is an effective option to reduce the risk of anaphylaxis from Andrographis for it to be suitable for inclusion as an ingredient in listed medicines,” the TGA wrote.
Aside from anaphylaxis, the TGA has received a total of 1368 adverse event reports related to medicines containing Andrographis, including ageusia, anaphylactic reaction and dysgeusia - a taste disorder.
