Summary Safety Review - Turmeric and Curcuminoids for Oral Use - Assessing the Potential Risk of Hepatotoxicity

Turmeric- or curcuminoid (active compounds found in turmeric)-containing natural health products (NHPs) for oral use

Hepatotoxicity (liver injury)

• Health Canada’s review of the available information found a possible link between the oral use of either turmeric- or curcuminoid-containing NHPs and the risk of hepatotoxicity, which, in rare cases, could lead to serious outcomes.

• Health Canada will update the monographs^a that include the medicinal ingredients turmeric and curcuminoids for oral use to include the risk of hepatotoxicity. Health Canada expects licence holders to update the risk information on product labels for all licensed turmeric- or curcuminoid-containing NHPs to:

  • include information about the warning signs and symptoms of hepatotoxicity, including yellowing of the eyes or skin, dark urine, nausea, vomiting and stomach pain,

  • advise consumers to stop using these products and consult a healthcare professional if symptoms occur, and

  • advise consumers to consult a healthcare professional before use if they have a liver disorder or are taking medications.

• Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.

Health Canada reviewed the potential risk of hepatotoxicity with the oral use of either turmeric- or curcuminoid-containing NHPs. This safety review was triggered by rare, but potentially serious, cases of hepatotoxicity with the oral use of either turmeric- or curcuminoid-containing health products reported to international regulatory authorities and published in the scientific literature.  

Turmeric mainly comes from the rhizome (a horizontal underground stem that sends out both shoots and roots) of the Curcuma longa plant, which is native to Asia and belongs to the ginger family. Curcuminoids, such as curcumin, are the active compounds in turmeric. They have antioxidant effects (help protect cells from harmful free radicals, which have been linked to certain health conditions) and other potential health benefits. Curcuminoids can be extracted from the rhizome and used in NHPs.

Turmeric, when used as a culinary spice and consumed in food in typical dietary amounts, has not been identified as a safety concern. Therefore, Health Canada’s review does not apply to turmeric or curcuminoids consumed as a food.

In addition, when used topically (applied to the surface of the skin) or as coloring agents in NHPs, turmeric or curcuminoids are less likely to be absorbed by the body. Therefore, they were also excluded from Health Canada’s review.

Hepatotoxicity, which can result from exposure to plant extracts and isolates, may progress to more severe complications, including liver failure.

• Turmeric- and curcuminoid-containing NHPs are authorized in Canada to help relieve joint pain and inflammation, and as a source of antioxidants. Turmeric and curcuminoids can also be used in herbal products to help with digestion or protect the liver, or in traditional Chinese medicines.

• Most turmeric- or curcuminoid-containing NHPs for oral use are not authorized for use by individuals under 18 years of age. They are also not recommended for use by individuals with biliary disorders (conditions affecting the gallbladder and/or bile ducts).

• Over 3,000 turmeric- or curcuminoid-containing NHPs for oral use have been authorized by Health Canada under the Natural Health Products Regulations.

• Authorized products are available in different dosage forms (capsules, tablets, powders and liquids), preparations, and ingredient combinations.

• Health Canada reviewed the available information provided by foreign regulatory agencies, as well as from searches of the Canada Vigilance database^b, the World Health Organization’s (WHO) adverse drug reaction database^c and the scientific literature.

• Health Canada reviewed 12 Canadian cases of hepatotoxicity in patients using either turmeric- or curcuminoid-containing NHPs orally. All 12 cases had insufficient clinical information and/or the presence of confounders (other factors that may have contributed to the occurrence of hepatotoxicity), such as underlying medical conditions and use of other medications and NHPs that are known to affect the liver, which limited further assessment. However, a link to the use of the product could not be ruled out.

• Health Canada reviewed over 60 international case reports of hepatotoxicity in persons using turmeric- or curcuminoid-containing health products orally, including from the WHO’s adverse drug reaction database and those that were published in the scientific literature.

  • Three deaths were reported, of which 2 were attributed to hepatotoxicity linked with the oral use of either turmeric- or curcuminoid-containing health products.

  • Although cases of hepatotoxicity are rare and its underlying cause is often unclear, the reports reviewed suggest a possible link between the oral use of either turmeric or curcuminoids and the risk of hepatotoxicity under conditions similar to how these products are used in Canada.

• International regulators, such as Australia’s Therapeutic Goods Administration, the Italian Ministry of Health and the French Agency for Food, Environmental and Occupational Health & Safety, have implemented a number of regulatory actions, such as label updates for oral turmeric- or curcuminoid-containing health products to include the risk of hepatotoxicity and safety alerts to inform consumers of the risk^1,2,3.

• The evidence suggests that the risk of hepatotoxicity associated with turmeric- or curcuminoid-containing NHPs appears to be idiosyncratic (not dependent on the dose or duration of use, and unpredictable in onset with risk factors not fully known). In most cases, the hepatotoxicity is reversible once use of the product is stopped.

• Health Canada’s review of the available information found a possible link between the oral use of either turmeric- or curcuminoid-containing NHPs and the risk of hepatotoxicity.

• Health Canada will update the monographs that include the medicinal ingredients turmeric and curcuminoids for oral use to include the risk of hepatotoxicity. Health Canada expects licence holders to update the risk information on product labels for all licensed turmeric- or curcuminoid-containing NHPs to:

  • include information about the warning signs and symptoms of hepatotoxicity, including yellowing of the eyes or skin, dark urine, nausea, vomiting and stomach pain,

  • advise consumers to stop using these products and consult a healthcare professionals if symptoms occur, and

  • advise consumers to consult a healthcare professional before use if they have a liver disorder or are taking medications.

• Information about NHPs licensed in Canada is available through the Licensed Natural Health Products Database.

• Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.

• Health Canada encourages consumers and healthcare professionals to report any side effects with the use of turmeric- or curcuminoid-containing NHPs, or other health products, to the Canada Vigilance Program.

• Health Canada will continue to monitor the safety information involving turmeric- and curcuminoid-containing NHPs, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, as well as what is known about the use of turmeric- and curcuminoid-containing health products both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

1. Australian Government Department of Health and Aged Care. Therapeutic Goods Administration. Safety Advisory: Medicines containing turmeric or curcumin - risk of liver injury. Published Aug 15, 2023. Available at: https://www.tga.gov.au/news/safety-alerts/medicines-containing-turmeric-or-curcumin-risk-liver-injury

2. Italian Ministry of Health – Decree of 28 July 2022 (In Italian only). Available at : https://www.cna.it/wp-content/uploads/2022/08/01082022-cambio-decreto-curcuma-associazioni-rev-2.pdf

3. ANSES (French Agency for Food, Environmental and Occupational Health and Safety), 2022. Adverse effects associated with the consumption of food supplements containing turmeric. Available at: https://www.anses.fr/en/content/adverse-effects-associated-consumption-food-supplements-containing-turmeric