Anaphylaxis Warnings Issued Over Andrographis: TGA Reviewing Safety

AN UPDATED safety review of herbal medicine ingredient Andrographis paniculata is currently underway, amid ongoing reports of anaphylaxis and other severe allergic reactions. The Therapeutic Goods Administration (TGA), which initiated the review, told Pharmacy Daily that "further advice on any regulatory action will occur in early 2026". More than 1,300 adverse events associated with andrographis are now listed on the TGA Database of Adverse Event Notifications (DAEN), including anaphylaxis, respiratory disorders and rashes, with one reported death due to anaphylaxis. The herb is found in products with claims around relief of cold and flu symptoms, and boosting the immune system. There are about 100 products listed on the Australian Register of Therapeutic Goods (ARTG) containing andrographis. It has been subject to several TGA safety reviews since 2008, and in 2019, new labelling regulations were introduced. Products containing the ingredient are required to carry a warning label stating: "Andrographis may cause allergic reactions in some people - if you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention" (or words to that effect). The TGA noted that little is currently known about the risk factors for andrographis allergy. "We are evaluating this safety concern and are considering whether the current label warning for andrographis is sufficient to address this risk," it stated. The TGA advises that health professionals should warn patients presenting with any type of allergic reaction after taking a medicine containing andrographis to avoid products containing the ingredient in the future, as subsequent reactions may be more severe. It also suggests that as a precaution, patients with a history of severe allergies to anything should avoid using medicines containing andrographis. KB The above article was sent to subscribers in Pharmacy Daily's issue from 21 Jan 26