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.
We issued a safety advisory in 2024 highlighting that medicines and herbal supplements containing W. somnifera may be associated with liver injury in very rare cases. This advisory was prompted by evidence in the scientific literature and an increase in reported adverse events.
Most of the reported Australian liver injury cases resolved following discontinuation of the product, although some required medical treatment and 4 cases required hospitalisation. The safety advisory also warned of sudden and potentially severe gastrointestinal symptoms in some people.
Since the publication of the 2024 advisory, we have received a further 4 adverse event reports with enough information to suggest a possible liver injury that may have been caused by medicines containing W. somnifera. However, in 2 cases, there were other ingredients linked to liver injury that may have contributed to the reported reactions. All resolved on discontinuation of the suspected medicine and none reported that hospitalisation was needed.
The available evidence indicates that while the risk appears to be very rare, there is a potential for liver injury associated with the use of this herbal ingredient.
What consumers should do
If you take medicines or herbal supplements containing W. somnifera, you should be aware of the potential for gastrointestinal side effects and the possible risk for liver injury in very rare cases. While liver injury is a very rare side effect, it can be severe. However, the risks are reduced if you recognise the early signs and stop taking the medicine or herbal supplement.
You should immediately stop taking it and seek medical advice if you experience any of the following symptoms:
- yellowing of the skin or eyes
- dark urine
- nausea
- vomiting
- unusual tiredness
- weakness
- stomach or abdominal pain
- loss of appetite.
Please be aware that sudden vomiting and/or diarrhoea after only one or 2 doses may not be liver damage, but rather an acute reaction that should resolve when the medicine is stopped. If this occurs, stop use and see a doctor for assessment.
As a precaution, if you currently have or have had liver problems, you should avoid medicines and herbal supplements containing W. somnifera.
If you have any concerns or questions about this issue, you should discuss them with your health professional. You can report any suspected side effects from medicines or herbal supplements containing W. somnifera to us or your health professional.
For more detailed information written for health professionals see this Medicine Safety Update article.