NPRA Updates on Reports of Kidney-Related and Liver-Related Adverse Reactions after Consumption of Ganoderma (Lingzhi / Reishi) Products

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The National Pharmaceutical Regulatory Agency (NPRA) wishes to advise the public on the risks of kidney-related and liver-related adverse reactions related to ganoderma which is also known as lingzhi or reishi.

 

Background

Ganoderma lucidum, an oriental fungus, is a large, dark mushroom with a glossy exterior and a woody texture. In China, G. Lucidum is commonly known as lingzhi, and in Japan, reishi or mannentake.1 It has a long history of use for promoting health and longevity in China, Japan, and other Asian countries.2 However, there are no clinical studies in humans supporting its effectiveness or safety.2,3 A variety of commercial G. Lucidum products are available in various forms, such as powders, tablets, capsules and tea. In Malaysia, there are 81 registered products of G. Lucidum or lingzhi as single ingredients that are available in the tablets, capsules, and powder forms.

The National Centre for Adverse Drug Reactions Monitoring, NPRA has detected an increase in the number of adverse reaction reports related to consumptions of ganoderma/ lingzhi with 11 cases in the past one (1) year.

 

Case reports related to the safety issue

Nine (9) reports of kidney-related adverse reactions

NPRA has received nine (9) local reports of kidney-related adverse reactions suspected to be associated with ganoderma-containing products in the last one (1) year. The reactions reported were increased in creatinine and urea (waste products normally removed by the kidneys) in the blood, acute interstitial nephritis (swelling of a part of the kidneys’ filters) and also worsening of existing kidney impairments. The adverse reactions were reported to occur as early as six (6) days and up to four (4) months after the consumption of ganoderma-containing products.

The patients were between 30 to 60 years of age. Most of them were also concurrently taking other medications and were reported to have underlying medical conditions, including chronic kidney impairments, diabetes, coronary artery disease (the build-up of plaque in the heart’s arteries that could lead to heart attack).

Out of the nine (9) patients that experienced the adverse reactions, seven (7) were hospitalised. Six (6) were reported to have recovered or were recovering (at the time of reporting) after stopping the suspected products, whereas the remaining three (3) did not recover.

 

Two (2) reports of liver-related adverse reactions

Within the same time period, NPRA has also received two (2) local reports of liver-related adverse reactions suspected to be associated with ganoderma-containing products. The symptoms included liver enzymes impairment (high bilirubin and liver enzymes), jaundice (yellowing of the skin and the whites of the eyes) and acute liver failure. These adverse reactions occurred as early as four (4) days and up to one (1) month after taking the ganoderma-containing products.

Both patients, aged 55 and 61 years old, were hospitalised. One patient had history of taking other traditional medications, while the other has underlying hypertension, gout, rheumatic heart disease (permanent heart valve damage caused by rheumatic fever) and chronic kidney disease.

After stopping the intake of the suspected products, one (1) patient was reported to have recovered and the other patient were recovering (at the time of reporting).

 

Safety concerns

Although currently there is no scientific data on the risks of kidney- or liver-related adverse reactions from taking ganoderma, NPRA would like to advise consumers to exercise caution when considering the use of ganoderma-containing products. This is particularly important in patients with underlying medical conditions including reduced kidney and/or liver functions.

 

NPRA will continue to closely monitor this safety issue and update the public of any other significant findings.

 

Advisory

Healthcare professionals and consumers are advised of the following:

  • Be aware that a number of local cases of liver-related adverse reactions have been reported in some individuals following the consumption of ganoderma-containing products (which is also known as lingzhi or reishi). This risk could be higher in those with underlying medical conditions.
  • For consumers, consult a doctor as soon as possible if you feel unwell or develop any of the following signs and symptoms of kidney- or liver-related adverse reactions when taking ganoderma:

Kidney: decreased in urine output or frothy urine, any swelling, shortness of breath, feeling fatigue or confusion, or feeling pain in the mid-back where kidneys are located.

Liver: nausea (feel like vomiting), loss of appetite, lethargy (feeling of lack in energy), dark urine, the whites of the eyes have turned yellow or the skin is yellow (jaundice).

  • For consumers, consult your doctor if you plan to try traditional or complementary medicines or treatments for any serious medical conditions, especially when you are suffering from chronic diseases such as diabetes, hypertension and kidney impairment.

 

Reference:

  1. Wachtel-Galor S, Yuen J, Buswell JA, et al. Ganoderma lucidum (Lingzhi or Reishi): A Medicinal Mushroom. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2011. Chapter 9. Available from: https://www.ncbi.nlm.nih.gov/books/NBK92757/ 
  2. Joob B, Wiwanitkit V. Linzhi (Ganoderma lucidum); evidence of its clinical usefulness in renal diseases. Journal of Nephropharmacology. 2016;5(1):9.
  3. Lin Z, Yang B, editors. Ganoderma and Health: Pharmacology and Clinical Application. Springer Nature; 2019 Nov 27.

 

 

Prepared by:

Nurul Aimi Mohd. Reduzan

Lee Sing Chet

NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA)

KEMENTERIAN KESIHATAN MALAYSIA (KKM)

[22 December 2020]

 

Disclaimer: The information provided in this article is published for general information purposes only and is not intended for a specific product. Patients and consumers should review their information with their healthcare providers.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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