Andrographis paniculata (Andrographis) and anaphylaxis - updated safety review and supplementary report

The TGA has completed an updated safety review with in depth analyses of adverse event data up to 31 December 2024, and a supplementary report considering adverse event data up to 31 December 2025, of the herb Andrographis paniculata (Andrographis) and the risk of anaphylaxis. We have published a media statement outlining proposed regulatory action to address this risk. We are currently consulting on this proposal with consumer associations, health professionals, affected medicine sponsors and industry peak bodies.

These updated reviews follow an earlier safety review that found Andrographis can cause serious allergic reactions, including anaphylaxis. The earlier safety review was published in 2015, together with a public safety alert issued in 2015.

Since 2019, medicines containing Andrographis have been required to carry a label warning about the risk of allergic reactions. However, despite these warnings, reports of anaphylaxis linked to Andrographis have continued.

In 2024, we published a safety alert and one medicine sponsor added a stronger and more prominent warning label as a further safety measure. These measures have not led to a meaningful reduction in the number of reports of anaphylaxis.

The first reports of anaphylaxis associated with Andrographis-containing medicines were received by the TGA in 2005 and up to 31 December 2025, the TGA has received 287 reports of anaphylaxis linked to medicines containing Andrographis, including one fatal case reported in 2024.

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The updated safety review and supplementary report

Evidence considered in the TGA’s updated safety review and supplementary report included:

• Australian and international adverse event reports
• formulations of the medicines involved in the Australian adverse events
• available published literature since November 2011
• a toxicology review of non‑clinical studies
• expert advice from a clinical immunology and allergy specialist, and
• expert advice from the Advisory Committee on Complementary Medicines (ACCM).

The evidence considered does not support stronger label warnings, formulation restrictions or further education as effective options to reduce the risk of anaphylaxis associated with Andrographis for it to be suitable for use as an ingredient in listed medicines. The updated review and supplementary report concluded that Andrographis may not be appropriately positioned within the low-risk regulatory framework of listed medicines.

Background

Andrographis is used in Indian and Chinese traditional medicine for conditions such as the common cold, flu and jaundice. It is often combined with other herbal ingredients, including Echinacea.

Around 80 products containing Andrographis are listed on the Australian Register of Therapeutic Goods (ARTG), although many are not currently being supplied in Australia. These products are available from supermarkets, health food stores and pharmacies for self-selection.

About anaphylaxis

Anaphylaxis is the most severe type of allergic reaction and is a medical emergency. It requires immediate treatment with adrenaline (epinephrine). Delayed treatment can be life‑threatening.

Symptoms of anaphylaxis can include:

• Difficult or noisy breathing.
• Swelling of the tongue.
• Swelling or tightness in the throat.
• Wheezing or persistent coughing.
• Difficulty speaking or a hoarse voice.
• Persistent dizziness or collapse.
• Becoming pale and floppy (in young children).
• Stomach pain or vomiting.

What we know about Andrographis-related anaphylaxis

• Reactions are unpredictable and can happen the first time someone takes it, or after taking it previously without any issue.
• Most people affected had no history of allergies or asthma.
• Symptoms usually began within 30 minutes
• Little is known about why Andrographis causes anaphylaxis.
• General factors that may increase the chance or severity of allergic reactions include viral infections, taking anti‑inflammatory medicines (such as ibuprofen), alcohol, or exercising around the time of exposure to an allergen.

What consumers should do

• Be aware of the signs of anaphylaxis, which can be triggered by many allergens, including Andrographis.
• If you think you or someone else is having anaphylaxis, call for emergency medical help immediately.
• Stop taking the product and seek medical advice if you experience any symptoms of an allergic reaction.
• Always speak to a health practitioner about your individual clinical circumstances.
• Always read medicine labels carefully before using a product.