ISSUE 5 OCTOBER
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Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 7 July 2026.
Summary
Cases of liver injury associated with herbal preparations containing Withania somnifera (W. somnifera), commonly known as Ashwagandha, continue to be reported both in Australia and internationally.
W. somnifera has been widely used in Ayurvedic and other traditional medicine systems. In Australia, products containing W. somnifera are readily available for consumers to purchase without the need for consultation with a health professional.
To date, no fatalities or liver transplant cases associated with W. somnifera have been reported in Australian consumers. However, the TGA is aware of at least 4 published international literature case reports of liver failure including one requiring liver transplant. Additionally, 3 fatalities in patients with acute-on-chronic liver failure associated with single-ingredient W. somnifera preparations have been reported by researchers in India.
What health professionals should do
In very rare cases, liver injury has been reported after consuming herbal products that contain W. somnifera. When assessing patients presenting with symptoms of liver injury, health professionals should consider potential involvement of complementary medicines. The use of products containing W. somnifera should be avoided in individuals with existing liver disorders.
Health professionals should also be aware that cases of acute onset of gastrointestinal symptoms – such as nausea, vomiting and diarrhoea – have been reported after consuming products containing W. somnifera. These symptoms may be easily mistaken for infectious gastroenteritis or food poisoning.
Some reports of liver injury received by the TGA have involved products purchased online from overseas sources. Patients should be advised to exercise caution when considering buying medicines (including herbal products) online, as products obtained from overseas are not regulated by the TGA for quality, safety or effectiveness.
See the full article on the TGA website.
