DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

Overview of Product(s)

Garcinia cambogia, also known as Garcinia gummi-gutta, is a herbal ingredient derived from the fruit of the Malabar tamarind tree that has long been used in Southeast Asia for its appetite-suppressing properties.^1-3 Products containing Garcinia cambogia, either alone or in combination with other ingredients, are commonly marketed for weight-loss purposes, which is an acceptable indication for natural or traditional products as listed in the Drug Registration Guidance Document for Malaysia.^3,4 One of the chemical components of the fruit rind, hydroxycitric acid, is thought to be the active ingredient responsible for its appetite-suppressing and anti-inflammatory activities and can also be synthetically produced for use in natural health products.^1-3

In Malaysia, there are currently 156 traditional products containing Garcinia cambogia, available either as single or multi-ingredient oral formulations registered with the Drug Control Authority (DCA).⁵ No products containing synthetically produced hydroxycitric acid are registered locally.

Overview of Safety Concern

Hepatotoxicity refers to liver damage resulting from exposure to harmful substances such as certain medications, toxins, or chemicals, which in severe cases can lead to liver failure.⁶ Contrary to the common perception that natural products are inherently safe, numerous herbal supplements have been associated with hepatotoxicity and are increasingly recognised as a cause of acute liver injury.^7,8

Source of Safety Concern

The National Pharmaceutical Regulatory Agency (NPRA) received information from Health Canada about the risk of hepatotoxicity associated with the use of natural health products containing Garcinia cambogia or its active compound, hydroxycitric acid.¹ The review conducted by Health Canada was based on information from foreign regulatory agencies, reports from the Canada Vigilance database, the World Health Organisation (WHO) adverse drug reaction database, and scientific literature. The available evidence indicates a potential association between the use of either Garcinia cambogia or hydroxycitric acid and hepatotoxicity. In response, Health Canada will update the monograph for Garcinia cambogia to include this risk, and expects license holders to update the corresponding risk information on product labels.¹

Background of Safety Issue

Several published reports over the years have highlighted concerns regarding the hepatotoxic potential of Garcinia cambogia, although the precise mechanism remains unclear.³ An animal study suggested that Garcinia cambogia may increase hepatic collagen accumulation and lipid peroxidation, leading to oxidative stress. The study also revealed increased expression of certain cytokines, such as tumour necrosis factor-α (TNF-α), contributing to hepatocyte injury and inflammatory response.

Many case reports have described liver injury involving the use of multi-ingredient supplements containing Garcinia cambogia.² In some cases, the products also contained other known or suspected hepatotoxins. More recently, acute liver injury has been reported in individuals consuming products containing only Garcinia cambogia. Available evidence further indicates that hepatotoxicity associated with Garcinia cambogia (hydroxycitric acid) appears to be idiosyncratic, meaning it is not dependent on the dose or duration of use, with unpredictable onset and risk factors that are not fully known.^1,2

According to the literature, patients often present with symptoms of hepatotoxicity within 1 to 4 weeks after consuming products containing Garcinia cambogia, although the time-to-onset may extend up to 12 months in some cases.^2,7-10 In most cases, the hepatotoxicity is reversible upon discontinuation of the product. However, some patients have presented with severe outcomes, including acute liver failure requiring liver transplantation or death.^1,2,7-10

Local Adverse Drug Reaction Reports¹¹

To date, the NPRA has received 16 reports with 39 adverse events suspected to be related to registered products containing Garcinia cambogia. Although there were no reports of hepatotoxicity, other liver-related adverse events were reported, including jaundice (2), transaminitis (2), acute hepatic failure (1), acute hepatitis (1), hepatitis (1), and hepatic enzyme increased (1). The reported time-to-onset ranged from 6 days to 1.5 years, involving patients aged between 29 to 68 years. Co-suspected or concomitant medications were reported in four (4) cases, and the patients’ outcomes were reported as recovered or recovering in five (5) cases.

Advice for Health Care Professionals

• While NPRA continues to review this safety issue, be aware of the potential risk of hepatotoxicity or other hepatic-related disorders associated with the use of Garcinia cambogia-containing products.
• Educate patients not to assume that herbal supplements are safe simply because they are natural, as they have been associated with hepatotoxicity.
• Advise patients to consult a healthcare professional before use, particularly if they have a pre-existing liver disorder or are taking other medications or natural products.
• Advise patients to stop using the product and seek medical attention if they experience signs or symptoms suggestive of hepatotoxicity, such as yellowing of the eyes or skin, dark urine, nausea, vomiting, abdominal pain, or fatigue.
• Patients presenting with unexplained acute hepatitis or liver failure should be questioned about their use of natural or traditional products to support accurate clinical assessment and management.
• Report all adverse events suspected to be related to the use of Garcinia cambogia to NPRA.

 References:

1. Health Canada. Summary Safety Review - Garcinia gummi-gutta and Hydroxycitric Acid - Assessing the Potential Risk of Hepatotoxicity [Internet]. 2025 Sep 19 [cited 2025 Nov 17]. Available from: https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1755272782909
2. Garcinia Cambogia [Internet]. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2019 Feb 13 [cited 2025 Nov 17]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548087/
3. Vuppalanchi R, Bonkovsky HL, Ahmad J, Barnhart H, Durazo F, Fontana RJ, Gu J, Khan I, Kleiner DE, Koh C, Rockey DC, Phillips EJ, Li YJ, Serrano J, Stolz A, Tillmann HL, Seeff LB, Hoofnagle JH, Navarro VJ; Drug-Induced Liver Injury Network. Garcinia cambogia, Either Alone or in Combination with Green Tea, Causes Moderate to Severe Liver Injury. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1416-e1425. Available from: https://doi.org/10.1016/j.cgh.2021.08.015
4. National Pharmaceutical Regulatory Agency (NPRA). Drug Registration Guidance Document (DRGD) Third edition Tenth Revision July 2025 [Internet]. 2025 [cited 2025 Nov 17]. Available from: https://www.npra.gov.my/easyarticles/images/users/1153/DRGD%20July%202025/Complete-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-10th-Revision-July-2025.pdf
5. National Pharmaceutical Regulatory Agency (NPRA). QUEST3+ Product Search [Internet]. 2025 [cited 2025 Dec 30]. Available from: https://www.npra.gov.my
6. Yale Medicine. Hepatotoxicity (liver toxicity) [Internet]. 2025 [cited 2025 Nov 17]. Available from: https://www.yalemedicine.org/clinical-keywords/hepatotoxicity
7. Corey R, Werner KT, Singer A, Moss A, Smith M, Noelting J, Rakela J. Acute liver failure associated with Garcinia cambogia use. Ann Hepatol. 2016 Jan-Feb;15(1):123-6. Available from: https://doi.org/10.5604/16652681.1184287
8. Ferreira V, Mathieu A, Soucy G, Giard JM, Erard-Poinsot D. Acute Severe Liver Injury Related to Long-Term Garcinia cambogia Intake. ACG Case Rep J. 2020 Aug 11;7(8):e00429. Available from: https://doi.org/10.14309/crj.0000000000000429
9. Lunsford KE, Bodzin AS, Reino DC, Wang HL, Busuttil RW. Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation. World J Gastroenterol. 2016 Dec 7;22(45):10071-10076. Available from: https://doi.org/10.3748/wjg.v22.i45.10071
10. McCarthy RE, Bowen DG, Strasser SI, Mckenzie C. The dangers of herbal weight loss supplements: A case report of drug-induced liver injury secondary to GARCINIA CAMBOGIA ingestion and literature review. Pathology. 2020. S147. Available from: https://doi.org/10.1016/j.pathol.2020.01.042
11. National Pharmaceutical Regulatory Agency (NPRA). The Malaysian National ADR Database (QUEST) [Internet]. 2025 [cited 2025 Oct 28]. Available from: https://www.npra.gov.my (access restricted)

Written by: Wo Wee Kee

Reviewed/Edited by: Lim Sze Gee, Dr Rema Panickar, Noor'ain Shamsuddin, Norleen Mohamed Ali