Medicines containing Andrographis paniculata safety advisory

About andrographis

Andrographis is a herbal ingredient permitted for use in low-risk medicines in Australia. Approximately 100 medicines listed in the Australian Register of Therapeutic Goods (ARTG) contain andrographis.

Andrographis is a herb commonly used in Indian and Chinese medicine and is known as the 'king of bitters'. It may be present in multi-ingredient herbal medicine products that are typically used for relief of cold and flu symptoms, or for immune support. 

Reports of allergic reactions

We have previously reviewed the safety of andrographis for use in listed medicines after receiving reports of adverse events associated with its use. We published a safety review in 2015 that suggested an association between andrographis and allergic reactions including anaphylaxis, and also published a safety alert. In 2019, labelling requirements were introduced to include the following statement on medicine labels:

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).

We have continued to monitor reports of allergy and anaphylaxis for medicines containing andrographis. Since 2005, we have received more than 300 reports of anaphylaxis and/or hypersensitivity reactions to medicines containing andrographis. More than 200 of these reports have been received since 2019. In June 2024, we received a report of an anaphylactic reaction with a fatal outcome in someone that had used a medicine containing andrographis.

More than 80% of the adverse events reported to us for andrographis are for multi-ingredient medicines that contain both andrographis and Echinacea species (echinacea) together with other ingredients. Echinacea is another herbal ingredient often used in medicines for relief of cold and flu symptoms and immune support. Echinacea has also been reported to cause allergic reactions, including anaphylaxis. 

Little is currently known about the risk factors for andrographis allergy. We are evaluating this safety concern and is considering whether the current label warning for andrographis is sufficient to address this risk.

Information for consumers

Please read the key messages at the top of this webpage. 

If you take medicines or herbal supplements containing andrographis, you should be aware of the potential for allergic reactions. In some reports made to us, a mild reaction occurred before a more severe reaction, including anaphylaxis. However, in other cases the first reported sign of an allergy was a severe reaction, even in people who had used the product previously without any reaction.

You should be cautious using these medicines if you do not have reliable access to medical care. This is because severe reactions have been reported to occur in patients who have previously used these medicines without a reaction.

If you have a history of allergic reactions, you should be cautious using a medicine containing andrographis and stop using it at the first sign of any allergic reaction. 

If you have previously experienced a severe allergic reaction including anaphylaxis to any trigger, you should avoid medicines containing andrographis. This is because the risk factors for a severe reaction to andrographis are unknown.

If you experience an allergic reaction to a medicine containing both andrographis and echinacea, you should avoid medicines containing either ingredient in the future. 

If you have any concerns or questions about this issue or experience any adverse effects, you should discuss them with your health professional. Report any suspected side effects from medicines or herbal supplements containing andrographis to us.

For further information on how we regulate registered and listed medicines, see How we regulate medicines.

Information for health professionals

Be aware that products containing andrographis can lead to allergic reactions which may be severe and can include anaphylaxis. Similarly, the herbal ingredient echinacea may also be involved in allergic reactions.

When treating patients who are presenting with symptoms of hypersensitivity, you should consider whether a complementary medicine could be involved. 

You should advise patients presenting with any type of allergic reactions after taking a medicine containing andrographis and/or echinacea to avoid products containing these ingredients in the future. This is because our adverse event data indicate that subsequent reactions may be more severe.

As a precaution, patients with a history of severe allergies, including anaphylaxis, should avoid using medicines containing andrographis and/or echinacea. 

Information for sponsors

Labels on products containing andrographis must warn consumers about the potential for allergic reactions. We remind you that as a sponsor you must report all serious adverse events and significant safety issues to us within the required timeframes detailed in the Pharmacovigilance responsibilities of medicine sponsors.

Reporting problems

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.

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.