Liver toxicity associated with products containing Ashwagandha

12-09-2023

Pharmacovigilance centre Lareb received four reports of liver toxicity in people who used products containing Ashwagandha. These reports showed that three people were recovering after withdrawal of these products. It is important to warn people about the risk of liver toxicity when using these products.

Ashwagandha (Withania somnifera), is an herb that has been used in traditional medicine of India for thousands of years. It promotes better sleep and has beneficial effects on both physical and mental stress. It is not a registered medicine in the Netherlands, but can be purchased without a prescription as a nutritional supplement.

Side effects Ashwagandha
Little research has been done into the safety of Ashwagandha, so not much is known about its side effects. Drowsiness, diarrhoea and abdominal pain are known side effects. Some cases of liver toxicity have been described in the literature after the use of products containing Ashwagandha.

Herbal products often consist of multiple herbs. Sometimes it may happen that the herbs have been mixed up or that herbal products contain herbs that are not listed on the label. Sometimes the product may be contaminated. Therefore, it cannot be ruled out that the liver toxicity in the reports was caused by something else in the product.

Warning
Herbal products are generally considered safe by people, but they can have serious side effects. Although liver toxicity with products containing Ashwagandha appears to be rare, it is important to be aware of this risk.

Lareb has informed the Netherlands Food and Consumer Product Safety Authority of these reports.

The full overview of the reports can be found here.