Despite adding warning labels to medicines containing Andrographis in 2019, the TGA has continued to receive a “sustained high number” of anaphylaxis reports associated with the products.
There were 287 anaphylaxis cases reported between 2005 and the end of 2025 – amongst a total of 1368 adverse events which also included ageusia and dysgeusia.
Andrographis is commonly used in Indian and Chinese traditional medicine for cold, flu and jaundice and is often combined with other herbal ingredients such as Echinacea.
“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 said.
In fact, most of those affected had no history of allergies or asthma. Symptoms usually began within 30 minutes.
Changes to make the warning label more prominent in 2024 also did not reduce the number of anaphylaxis reports.
“Notably there has been no decline in anaphylaxis reports received in 2025 when compared to the most recent years (2022 and 2023) prior to the strengthened label warning. This suggests that the strengthened label warning has not effectively reduced the number of anaphylaxis cases associated with this medicine,” the TGA said.
“Andrographis is associated with a risk of life-threatening anaphylaxis that is inconsistent with the low-risk regulatory framework of listed medicines.”
They note that because anaphylaxis associated with Andrographis is unpredictable and usually progresses rapidly, warning labels would not be expected to reduce the number of cases unless they lead people to avoid medicines containing it.
“Current risk mitigation strategies, including stronger label warnings, have not reduced the risk of anaphylaxis from Andrographis for it to be suitable for use in listed medicines. – TGA”
General factors that may increase the chance or severity of allergic reactions include viral infections, taking anti-inflammatory medicines, alcohol, or exercising around the time of exposure to an allergen, the TGA said.
While most of the anaphylaxis cases (83%) involved multi-ingredient products that also contained echinacea, 12% did not contain it. There were also 15 anaphylaxis reports (5%) for medicines with Andrographis as the sole active ingredient, confirming a signal that Andrographis is the likely culprit.
“This is also supported by the far smaller number of anaphylaxis cases related to medicines containing Echinacea without Andrographis present in the medicine,” the TGA added, noting that in the same 20 year period there have been only 10 such cases, eight of which also included other ingredients.
You can read the TGA’s safety review and supplementary report here.
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