Medicines containing turmeric or curcumin - risk of liver injury

Consumers and health professionals are advised that medicines and herbal supplements containing the herb Curcuma longa (turmeric) and/or curcumin may cause liver injury in rare cases. This risk also relates to other ingredients from the Curcuma species as they contain naturally occurring curcumin: Curcuma aromatica, Curcuma zanthorrhiza and Curcuma zedoaria.

Medicines and herbal supplements containing these Curcuma species and/or curcumin can be bought in supermarkets, health food shops and pharmacies without a prescription and without the advice of a health professional. There are over 600 listed medicines included in the Australian Register of Therapeutic Goods (ARTG) that contain these Curcuma species and/or curcumin.

Link with liver injury

The TGA has received 18 reports of liver problems experienced by consumers taking products containing Curcuma longa (turmeric) and/or curcumin up to 29 June 2023. Nine of these reports had enough information to suggest a liver injury that may have been caused by the Curcuma longa (turmeric) or curcumin product. Of these, in 4 cases there were no other ingredients likely to have contributed to the liver injury. Two of these cases were severe, including one that had a fatal outcome. The other 5 cases involved products that contained other ingredients that may have contributed to liver injury.

In addition to these cases, there have been several Australian and overseas case reports in the scientific literature, and multiple cases reported to regulators in other countries.

In response to these reports, the TGA completed a safety investigation of the ingredients Curcuma longa (turmeric) and curcumin and the risk of liver injury. Available evidence shows that there is a rare risk of liver injury from taking Curcuma longa (turmeric) and/or curcumin in medicinal dosage forms. The risk may be higher for products with enhanced absorption or bioavailability and/or higher doses. People with existing or previous liver problems may be more likely to develop this rare adverse event. However, there is not enough information at this time to conclusively identify which medicines are higher risk. The TGA will continue to monitor this issue and is currently considering further regulatory action, including consultation on a label warning. We will publish the outcome of this consultation including the details of any new labelling requirements in late 2023.

The risk of liver injury does not appear to relate to Curcuma longa (turmeric) when consumed in typical dietary amounts as a food.

About Curcuma species and curcumin

Curcuma longa (turmeric) is a plant that has been used as a food spice for over 4,000 years, as well for medicinal purposes in traditional Indian (Ayurvedic) and Chinese medicines. Curcumin is a naturally occurring component in Curcuma longa (turmeric) and can be isolated and used as an active ingredient in medicines.

Curcumin also naturally occurs in other Curcuma species permitted for used in listed medicines. These are Curcuma aromatica, Curcuma zanthorrhiza and Curcuma zedoaria. Because these Curcuma species contain curcumin, there is also a risk of liver injury from consuming medicines/herbal supplements that contain any of these Curcuma ingredients.

Information for consumers

If you take medicines or herbal supplements containing Curcuma species and/or curcumin you should be aware of the risk for liver injury in rare cases. While liver injury is a rare adverse event 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.

As a precaution, if you currently have or have had liver problems, you should avoid medicines and herbal supplements containing the above Curcuma species and/or curcumin.

If you have any concerns or questions about this issue, you should discuss it with your health professional. Report any suspected side effects from medicines or herbal supplements containing the above Curcuma species and/or curcumin to the TGA or your health professional.

Information for health professionals

Health professionals should be aware that products containing Curcuma longa (turmeric), Curcuma aromatica, Curcuma zanthorrhiza, Curcuma zedoaria and/or curcumin may cause 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 the above Curcuma species and/or curcumin should be avoided in patients with existing or previous liver pathologies.

Information for sponsors

Sponsors of products containing the above Curcuma species and/or curcumin 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 the TGA within required timeframes.

Further reading

Adverse effects associated with the consumption of food supplements containing turmeric - The French Agency for Food, Environmental and Occupational Health and Safety (ANSES).

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.

The TGA 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.