Medicines containing Withania somnifera (Withania, Ashwagandha)

Consumers and health professionals are advised that medicines and herbal supplements containing the herb Withania somnifera may cause side effects (known as ‘adverse events’) in some people. This includes sudden and potentially severe gastrointestinal symptoms in some people and, in very rare cases, may be associated with liver injury.

Withania somnifera is a widely used medicinal herb with a long history of traditional use in Ayurvedic medicine. It can be bought in supermarkets, health food shops and pharmacies without a prescription and without the advice of a health professional. About 320 medicines listed in the Australian Register of Therapeutic Goods (ARTG) contain Withania somnifera.

Gastrointestinal side effects

We are monitoring reports of gastrointestinal problems (side effects) experienced by consumers taking products containing Withania somnifera, such as sudden severe nausea, vomiting and diarrhoea. In some reports, vomiting and diarrhoea occurred after a single dose and, in some cases, it was initially mistaken for food poisoning.

Reactions resolved after discontinuation of the product but 16 cases were still severe enough to require hospitalisation. Some of these cases involved other ingredients known to cause gastrointestinal side effects, but severe reactions requiring hospitalisation are not expected from these ingredients. However, it is still possible they may have contributed in some cases.  

Very rare link with liver injury

We have received 12 reports of liver problems experienced by consumers taking products containing Withania somnifera up to 5 February 2024. Seven of these reports had enough information to suggest a liver injury that may have been caused by Withania somnifera. In 4 of these cases there were no other ingredients likely to have contributed to the liver injury. The other 3 cases involved additional products or ingredients that may have contributed to liver injury. Most patients recovered after they stopped using Withania somnifera, although some required medical treatment. Four cases required hospitalisation.

In addition to these reports, there have also been further overseas reports in the scientific literature and multiple cases reported to regulators in other countries that suggest Withania somnifera may cause liver injury. 

In response to these reports, we completed a safety investigation of the ingredient Withania somnifera and the risk of liver injury. Available evidence shows that there may be a very rare risk of liver injury from taking Withania somnifera. 

This is a relatively new issue globally, and we are continuing to closely monitor emerging evidence. If further substantiating evidence arises, regulatory actions will be considered. This could include warning statements on product labels or other changes to the requirements for ingredients permitted for use in listed medicines. 

Information for consumers

If you take medicines or herbal supplements containing Withania 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 Withania 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 Withania somnifera to us or your health professional.

Please note that some reports of liver damage involved products purchased online from overseas. You should exercise caution when considering buying medicines online. Medicines bought online from overseas are not regulated by us for quality and safety.

The benefits of purchasing complementary medicines that are regulated by us include that you have assurances that those products contain the ingredients listed on the label and are made under strict manufacturing standards. If you buy unregulated medicines, either from a local retailer or online, you may be wasting your money and risking your health.

You can identify if a medicine has been included on the ARTG by checking to see if it has an AUST R or AUST L number on the medicine label. For further information on how we regulate registered and listed medicines, see How we regulate medicines.

Information for health professionals

Health professionals should be aware that products containing Withania somnifera can cause acute, severe vomiting and diarrhoea that may be mistaken for infectious gastroenteritis. 

In very rare cases, these products may also case liver injury in some individuals. When treating patients who are presenting with symptoms of liver injury, you should consider whether a complementary medicine could be involved. Use of medicines or herbal supplements containing Withania somnifera should be avoided in patients with existing or previous liver pathologies.

Information for sponsors

Sponsors of products containing Withania somnifera should be aware of this issue and take appropriate risk mitigation action if the available evidence alters the risk-benefit profile for their products. Sponsors are also reminded of their obligation to report all serious adverse events and significant safety issues to us within required timeframes.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our 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.