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Ganoderma lucidum

Ganoderma lucidum is a basidiomycete belonging to the family Ganodermataceae, characterized by its large, woody, shelf-like fruiting bodies with a shiny, reddish-brown to dark varnish-like cap that measures up to 50 cm in diameter and grows laterally from the substrate. The name lucidum, derived from Latin meaning "shiny," reflects the distinctive lacquered appearance of its pileus, which features a concentric zonation and white to yellowish pore surface underneath, releasing brown spores. Native to subtropical and tropical regions, it primarily inhabits decaying trees such as oaks (Quercus spp.) and other angiosperms in forests, parks, and gardens, where it acts as a white-rot , breaking down and . Widely recognized as reishi in Japan, lingzhi in China, and the "mushroom of immortality" in traditional lore, G. lucidum has been documented in ancient Asian texts like the Shen Nong Ben Cao Jing (circa 25–220 AD) for its reputed ability to enhance vitality, prolong life, and treat ailments such as , , and . Historically rare and reserved for due to its in the wild, the fungus is now extensively cultivated on substrates like and wood logs in controlled environments across , , and to meet demand for medicinal and supplemental products. Contemporary scientific investigations have substantiated many traditional claims, revealing that G. lucidum contains over 400 bioactive compounds, including (such as β-glucans, comprising 1–5% of dry weight) and triterpenoids (like ganoderic acids, up to 8% in some strains), which exhibit potent activities. These include immunomodulatory effects by stimulating production and activity, antioxidant properties that scavenge free radicals, antitumor potential through induction in cancer cells, and anti-inflammatory actions via inhibition of pro-inflammatory mediators. Clinical studies, such as those evaluating extracts, have shown benefits in improving immune in cancer patients and reducing , though further large-scale trials are needed to confirm efficacy and safety. The fungus's , mycelia, and fruiting bodies are all utilized in extracts, powders, and teas, positioning G. lucidum as a cornerstone of modern nutraceuticals and integrative .

Taxonomy and nomenclature

Etymology

The genus name derives from the Greek words ganos (brightness or sheen) and derma (skin), alluding to the glossy, lacquered surface of the fruiting body. The specific epithet lucidum comes from the Latin word lucidus, meaning shiny or brilliant, which similarly describes the varnished, reflective appearance of the mushroom's cap. This scientific binomial was established in 1881 by Finnish mycologist Petter Adolf Karsten, who introduced the genus with G. lucidum as its based on earlier descriptions. In East Asian cultures, Ganoderma lucidum is known by names that reflect its revered status in . The Chinese term lingzhi (靈芝) combines ling (spiritual or divine) and zhi (mushroom or supernatural plant), translating to "herb of spiritual potency" or evoking the essence of . Similarly, the Japanese name reishi (霊芝) shares the same characters and etymological roots, emphasizing efficacy, while an alternative Japanese term mannentake (萬年茸) means "10,000-year ," underscoring beliefs in its longevity-promoting properties.

Classification and synonyms

Ganoderma lucidum belongs to the kingdom Fungi, phylum Basidiomycota, class Agaricomycetes, order Polyporales, family Ganodermataceae, and genus . It is recognized as the of the genus Ganoderma, originally described by in 1781 and validly published by Karsten in 1881. Phylogenetic studies utilizing molecular markers, including the (ITS) region of nuclear and mitochondrial small-subunit sequences, have illuminated the evolutionary relationships within Ganoderma. These analyses position G. lucidum within a monophyletic of the Ganodermataceae, highlighting its close affinity to other laccate species while distinguishing it from non-laccate taxa. Such data have resolved prior ambiguities in genus-level classifications, confirming the transfer of related species from obsolete genera like Fomes and Elfvingia. The nomenclature of G. lucidum encompasses several historical synonyms, including Boletus lucidus (), Polyporus lucidus, and Fomes lucidus, which arose from early classifications based on morphology. Reclassifications to the modern genus were driven by improved understanding of spore characteristics and phylogenetic evidence, particularly as molecular tools revealed that many synonyms represented morphologically similar but genetically distinct entities. Debates persist on species delimitation within the G. lucidum complex, exacerbated by the historical lumping of diverse laccate (shiny-surfaced) and non-laccate forms under a single name. Phylogenetic analyses of ITS and translation elongation factor 1-α (tef1-α) loci have delineated at least 13 distinct species globally, forming three major lineages not aligned with , underscoring the need for integrative combining and . This complexity has implications for accurate identification, especially in medicinal contexts where G. lucidum stricto is primarily , while Asian variants like G. lingzhi were formerly synonymous.

Morphology

Macroscopic features

The fruiting bodies of Ganoderma lucidum, referred to as basidiocarps, exhibit a characteristic bracket-shaped or fan-like (flabelliform) , often appearing shelf-like or kidney-shaped when attached to substrates. These structures typically measure 5–30 cm in width, though sizes can range from a few cm to over 100 cm in exceptional cases depending on environmental conditions, , and . The upper surface of the is distinctly shiny and varnished (laccate), presenting a glossy appearance that ranges from reddish-brown to or dark brown tones, with concentric zones of color that may include whitish margins in younger specimens. As the fruiting body matures, the surface shifts from brownish-orange to reddish-brown shades, enhancing its lacquered sheen. The texture is tough and woody, contributing to a leathery consistency that supports growth patterns on wood. The underside displays a white to cream-colored hymenophore composed of pores, with 4–6 small, circular to angular pores per millimeter that may darken to brownish with age. The stalk, when present, is lateral, short, and stocky, colored dark brown to black, but it is often absent in sessile forms. Variations in macroscopic features, such as color intensity (from light brown to hues) and overall , are observed across different strains, geographic populations, and developmental stages, reflecting high . These external traits have historically facilitated identification for traditional medicinal harvesting.

Microscopic features

Under microscopy, Ganoderma lucidum exhibits a trimitic hyphal system composed of generative, skeletal, and binding hyphae. Generative hyphae are , thin-walled, and measure 2–4 μm in diameter, often featuring clamp connections. Skeletal hyphae are thick-walled to solid, yellowish-brown, and 4–8 μm wide, while binding hyphae are thick-walled, branched, and 3–5 μm in diameter. The basidiospores are a key diagnostic feature, appearing and truncate at the apex, with dimensions of (8–)9–11(–12) × 5.5–7 μm (Q = 1.5–1.8). They possess a double-walled , featuring a hyaline inner wall and a brown outer wall, with the inner wall ornamented by fine interwall pillars that create a subtly echinulate appearance. Basidia are clavate, measuring 20–30 × 7–10 μm, and typically bear four sterigmata; cystidia are absent from the . For microscopic examination, tissues are commonly mounted in 3–5% KOH, sometimes with 1–3% or Melzer’s to enhance contrast; skeletal and binding hyphae often stain yellowish-brown in KOH, aiding identification. These traits, particularly the ornamented double-walled basidiospores and trimitic hyphae, distinguish G. lucidum from morphologically similar species in the .

Ecology and distribution

Habitat preferences

Ganoderma lucidum primarily functions as a saprotroph, colonizing dead or decaying wood, while also exhibiting weakly parasitic behavior on living trees, particularly hardwoods such as (Quercus spp.), (Acer spp.), and (Fagus spp.). As a white rot , it degrades , , and in these substrates, leading to a characteristic whitening and structural breakdown of the wood. This dual lifestyle allows it to infect weakened or stressed trees before transitioning to saprotrophic post-mortem. The fungus shows a strong preference for temperate climates, where it thrives in humid forest environments, conditions that support mycelial growth and fruiting body development. These preferences align with its natural occurrence on angiosperm (broadleaf) wood, where it is commonly associated with stumps, roots, and trunks of trees; it rarely colonizes coniferous wood due to differences in composition. In its , G. lucidum plays a vital role in forest ecosystems by facilitating wood decomposition, which releases essential s like carbon, , and minerals back into the , thereby contributing to and supporting . This process enhances and aids in the breakdown of , underscoring its importance in maintaining healthy dynamics. Note: Due to taxonomic revisions, the species traditionally called G. lucidum in Asian medicinal contexts is now classified as lingzhi; this section describes G. lucidum stricto.

Global distribution

Ganoderma lucidum is native to and parts of northeastern , where it naturally occurs on decaying hardwood trees in temperate forests. This species has a limited native range, often documented in mycological contexts. Through human-mediated dispersal, primarily via in ornamental plants, cultivation kits, and products, G. lucidum has expanded to and . In these areas, established populations are typically limited and linked to anthropogenic introduction rather than natural . Introduced populations thrive in temperate zones, including parts of the —where sightings occur on hardwood hosts in forested and urban settings—supported by suitable climates similar to its native habitats. Factors driving this spread include global commerce and, potentially, warming trends that extend viable habitats, though human activity remains the dominant . Post-2000 records highlight range shifts, with notable sightings in urban forests across and , such as localized naturalization in and , reflecting adaptation to modified environments. These observations underscore the species' increasing presence beyond traditional ranges due to ongoing dispersal.

Cultivation

Propagation techniques

Ganoderma lucidum propagation primarily relies on aseptic techniques to initiate cultures from s or explants, yielding pure mycelial strains for further cultivation. , though effective for obtaining monokaryotic mycelium, is challenging due to inherently low germination rates under artificial conditions, often below 20% without specific inducers. s are harvested as prints by positioning sterile petri dishes beneath mature fruiting bodies for 24 hours to collect the powdery deposit. The s are then suspended in sterile , serially diluted, and spread or streaked onto media such as water or water (prepared from boiled extract solidified with 2% ). To enhance , supplements like 1-2% ethyl alcohol are added, with plates incubated at 27 ± 1°C and monitored at intervals up to 96 hours, resulting in hyphal outgrowth forming monokaryotic mycelium. Richer media like extract often yield negligible germination (0%), underscoring the preference for minimalistic substrates. Tissue culture from fruiting body explants provides a more reliable method for dikaryotic production, starting with small (5-10 mm) pieces excised from the stipe or cap interior under sterile conditions. Surface sterilization is critical to eliminate contaminants; explants are typically immersed in 70% for 1-2 minutes, followed by 2% for 10 minutes, and rinsed three times in sterile . The treated explants are then plated on media, such as (; 200 g potato infusion, 20 g dextrose, 20 g , 5.6) or malt extract agar (MEA), and incubated at 28-32°C in the dark. Initial mycelial outgrowth, white and cottony, emerges within 4-7 days, fully colonizing the plate in 10-14 days under optimal conditions. supports rapid mycelial growth at around 25-30°C. Cloning techniques further facilitate strain preservation and multiplication, often using basidiospore prints as described for or preparing from established . For , (e.g., or ) supplemented with 20% is moistened to 60% water content, packed into heat-resistant bags or jars, and sterilized by autoclaving at 121°C for 90-120 minutes. The cooled is inoculated with 5-10% (v/w) actively growing from cultures or liquid suspensions, then incubated at 25-30°C in darkness until full colonization, typically requiring 2-4 weeks. This method allows for genetic uniformity by selecting high-performing dikaryotic strains. These propagation approaches are hindered by the fungus's slow growth rate, with initial establishment often taking 2-4 weeks, and heightened risks from airborne bacteria and fungi, which demand rigorous aseptic protocols including hoods sterilized with UV light and 95% . Dead or non-viable explants can fail entirely, emphasizing the need for fresh material. Such lab-initiated cultures form the basis for scaling to substrates.

Commercial practices

Commercial production of Ganoderma lucidum relies on solid-state fermentation techniques, utilizing substrates like , wood logs, or -based bags to support mycelial growth and fruiting body development. sawdust, often comprising 75-80% of the mix, is supplemented with wheat bran (10-15%) and (1-2%) to enhance nutrient availability and aeration, promoting efficient colonization. Wood logs from species such as or serve as a traditional alternative for outdoor or semi-commercial setups, while grain bags facilitate initial propagation before transfer to bulk substrates. Recent advances include using lignocellulosic wastes like stalks or corn cobs for sustainable . The cultivation process unfolds in distinct growth phases optimized for yield. The spawn run phase, where mycelium colonizes the substrate, typically lasts 4-6 weeks under controlled incubation at 25-30°C. This is followed by primordia formation, induced by environmental shifts, leading into the fruiting phase that extends 2-3 months, during which antler-like or fan-shaped bodies mature. These timelines vary slightly with substrate type and strain, but sawdust-based systems generally accelerate overall production compared to log methods. Environmental controls are critical for successful large-scale operations, particularly during fruiting. Carbon dioxide levels must be maintained below 1000 ppm to prevent elongated stems and support proper pinning, achieved through increased ventilation. Light cycles, often 10-12 hours of low-intensity exposure (800-3000 lux), trigger primordia initiation and cap development, while humidity is held at 85-95% and temperatures at 24-28°C. These parameters ensure high-quality fruiting bodies in climate-controlled facilities. Global production is dominated by , which accounts for approximately 80% of the supply as of , supported by more than 200 dedicated factories and extensive research infrastructure, with annual output reaching about 160,000 tons of Ganoderma spp. This concentration stems from longstanding expertise in artificial cultivation techniques, enabling efficient scaling for export-oriented industries.

Historical and cultural significance

Traditional uses

Ganoderma lucidum, known as lingzhi in Chinese, has been utilized in (TCM) for over 2,000 years, with records dating back to ancient texts that highlight its role as a superior promoting and . Classified as a top-grade, non-toxic remedy in the Shennong Bencao Jing (circa 25–220 AD), one of the earliest pharmacopeias, it was prescribed to replenish (vital energy), strengthen the physique, and support overall well-being, including immune function through tonifying effects on the heart and liver. This ancient text, attributed to the legendary Emperor , describes its use for enhancing and preventing fatigue, establishing it as an emblem of and endurance in early medicinal practices. Similar reverence is found in traditions as reishi and in medicine as yeongji, where it is valued for promoting health and . In Taoist traditions, G. lucidum held profound spiritual significance, often revered as the "mushroom of immortality" due to its association with divine power and eternal life. Taoist practitioners and monks incorporated it into rituals and elixirs aimed at achieving , spiritual potency, and , viewing it as a symbol of auspiciousness and harmony with the cosmos. Its depiction in cultural artifacts and texts, such as the by (4th century AD), underscored its role in quests, where it was sought in sacred groves as a celestial gift for elevating the spirit and mind. Traditionally, wild specimens of G. lucidum were harvested and prepared in simple forms to preserve their purported essences, including decoctions for hours to extract beneficial properties, hot water teas for daily consumption, ground powders mixed into porridges or elixirs, and alcohol-based tinctures for concentrated use. These methods, detailed in classical TCM compendia like the Ben Cao Gang Mu (1596 AD), emphasized gentle or to align with the herb's calming and nourishing qualities, often combined with other botanicals for synergistic effects in promoting vitality. Over time, these historical applications have influenced contemporary herbal products, adapting ancient wisdom to modern formulations.

Modern commercialization

Ganoderma lucidum, commonly known as reishi, has seen significant commercialization in the , primarily as a and wellness ingredient. The global reishi market was valued at approximately $5.03 billion in 2025, driven by rising consumer interest in natural health products. Commercial products derived from G. lucidum are available in diverse forms, including dietary supplements such as capsules and liquid extracts, herbal teas, and cosmetic formulations like creams and serums for skin health. To ensure product quality and efficacy, industry standardization efforts focus on key bioactive components, particularly , with pharmacopoeial requirements such as ≥0.90% (as anhydrous glucose) in dried material per the Chinese Pharmacopoeia (2020). Major production occurs in , which dominates global output due to its extensive cultivation infrastructure, followed by and other Asian countries. The is a key for processing and branding, emphasizing " reishi" certifications to appeal to international consumers. Regulatory frameworks support its use in food products; for instance, beta-glucans derived from G. lucidum have been granted (GRAS) status by the U.S. for incorporation into baked goods and other foods at levels up to 1%. This status facilitates broader commercialization while underscoring the need for verified safety in non-drug applications.

Phytochemicals

Major compounds

Ganoderma lucidum contains a diverse array of phytochemicals, with triterpenoids and representing the predominant classes due to their abundance and structural complexity. These compounds contribute to the fungus's characteristic properties, though their profiles vary across different parts of the organism. Triterpenoids, numbering over 300 distinct structures, form a major group in G. lucidum, primarily consisting of lanostane-type skeletons with molecular masses ranging from 400 to 600 . Key examples include ganoderic acids A through Z (such as ganoderic acids A, C2, D, F, DM, T, X, and Y) and related lucidenic acids, along with ganoderic alcohols, aldehydes, and lactones like ganoderic acid Df and Me. These liposoluble, water-insoluble compounds are concentrated in the fruiting bodies, mycelia, and spores, often imparting a bitter to extracts. Polysaccharides, another primary constituent, are predominantly water-soluble beta-glucans with molecular weights typically between 10^5 and 10^6 Da, though ranges from 10^3 to 10^6 Da have been reported. Representative types include (1→3)-β-linked with (1→6) branches, heteroglucans, and ganoderan composed of D-glucose, D-mannose, and other monosaccharides. These are extracted from fruiting bodies, spores, and mycelia, with higher yields often observed in spores (up to 1.81% content after wall-breaking). Additional compound classes include sterols, peptides, and . Sterols exceed 20 variants, with as the principal one (comprising about 3‰ of total sterols) and ergosterol peroxide as a notable . Peptides feature fungal immunomodulatory proteins and oligopeptides, such as LingZhi-8 (LZ-8). encompass around 16 identified types, including adenosine derivatives, uridine, and uracil. The composition of these compounds varies by growth stage and substrate; for instance, mature fruiting bodies exhibit elevated triterpenoid levels compared to mycelia, while lignocellulosic substrates like wood or influence overall yields, with triterpenes often higher in fruiting bodies grown on specific woods such as Erythrophloeum fordii. content also differs, being more abundant in spores and mycelia under optimized conditions. Recent reviews as of 2024 indicate over 200 types have been identified, with ongoing structural characterizations.

Analytical methods

High-performance liquid chromatography-mass spectrometry (HPLC-MS) is a primary technique for identifying and quantifying triterpenoids in Ganoderma lucidum, offering high resolution for separating structurally similar compounds like ganoderic acids. Reversed-phase HPLC typically uses a C18 column with a elution of acetonitrile-water mixtures, often acidified with 0.2% acetic acid or to enhance and peak separation. For example, tandem mass spectrometry (ESI-MS^n) in combination with diode array detection (DAD) has enabled the characterization of 32 triterpenoids, including six novel ones, from chloroform extracts of G. lucidum fruiting bodies, with fragmentation patterns revealing diagnostic ions for lanostane-type structures. Ultra-high-performance liquid chromatography- (UPLC-MS/MS) variants provide faster analysis, achieving limits of detection as low as 0.1 ng/mL for key triterpenoids in spores, supporting quality assessment in commercial products. Nuclear magnetic resonance (NMR) is essential for the structural elucidation of purified triterpenoids, such as ganoderic acids, by providing detailed proton and carbon environments. One-dimensional ¹H NMR and ¹³C NMR spectra display characteristic chemical shifts, for instance, methyl singlets at δ 0.8-1.2 ppm for the lanostane skeleton and carbonyl signals around δ 180 ppm for carboxylic acids in ganoderic acids A and B. Two-dimensional techniques like COSY, HSQC, and HMBC further confirm connectivity and . Hyphenated approaches, such as , allow direct ¹³C NMR detection of triterpenoids in crude extracts without prior , facilitating rapid profiling of G. lucidum metabolites. This method has been pivotal in isolating and verifying over 300 triterpenoids from the since the . Polysaccharides in G. lucidum are quantified using gravimetric assays, which involve of crude extracts followed by drying and weighing the precipitate, or more sensitively via colorimetric methods. The phenol-sulfuric acid assay is the standard colorimetric approach, where are hydrolyzed to monosaccharides, dehydrated to derivatives, and reacted with phenol to produce an orange-red measured at 490 nm, with glucose as the reference standard; this has quantified total at approximately 25% in fruiting body extracts. Gravimetric methods complement this by providing absolute yields post-purification, though they are less specific for β-glucans. These assays ensure reproducibility in extract preparation, with reported polysaccharide contents varying from 10-40% depending on extraction conditions. Quality control for G. lucidum herbal extracts follows international standards like ISO 21315:2018, which mandates test methods for macroscopic and microscopic identification, determination of foreign matter, loss on drying, total ash, acid-insoluble ash, residues, , and microbial limits in fruiting bodies. While not prescribing specific assays, it recommends HPLC for triterpenoids and colorimetric methods for to verify minimum content thresholds, ensuring consistency in commercial decoction pieces and . Adherence to these guidelines supports traceability and safety in global trade.

Pharmacology

Bioactive mechanisms

The bioactive mechanisms of Ganoderma lucidum primarily involve such as beta-glucans and triterpenoids like ganoderic acids, which interact with cellular pathways to modulate immune responses, reduce , and inhibit tumor growth. These compounds exert effects through receptor-mediated signaling and gene regulation, as demonstrated in preclinical models. In immunomodulation, beta-glucans from G. lucidum activate the (TLR4) pathway, leading to MyD88-dependent signaling that enhances production, including interleukin-6 (IL-6) and tumor factor-alpha (TNF-α). This activation promotes and responses, bolstering innate immunity and in murine models. Similarly, like GLP-1 synergize with triterpenoids to target TLR4/, amplifying balance without excessive inflammation. Antioxidant activity arises from triterpenoids scavenging (ROS) via activation of the Nrf2 pathway, which upregulates heme oxygenase-1 (HO-1) and other detoxifying enzymes. In cellular assays, ganoderic acid A inhibits ROS accumulation and enhances (SOD) activity, mitigating oxidative damage in fibroblasts and hepatocytes. Animal studies further show that G. lucidum triterpenoids reduce (MDA) levels and restore in (CCl4)-induced liver injury models. Anti-tumor effects are mediated by ganoderic acids inducing through modulation of proteins and activation. Ganoderic acid DM upregulates Beclin-1, which sequesters anti-apoptotic , triggering -3 activation and mitochondrial release in non-small cell cells. In vitro models of demonstrate that ganoderic acid T disrupts mitochondrial membranes, leading to -3 cleavage and reduced cell viability. These pathways inhibit and in xenograft mouse models. Preclinical evidence from and studies highlights liver protection, where G. lucidum regulate Nrf2 to suppress ROS in acetaminophen-induced in mice, lowering (ALT) and aspartate aminotransferase (AST) levels. In CCl4-treated rats, proteoglycans from G. lucidum mycelia decrease hepatic and inflammatory markers, preserving tissue architecture. These mechanisms underscore the compound's potential in oxidative stress-related liver disorders.

Clinical evidence

Clinical evidence from randomized controlled trials (RCTs) and meta-analyses indicates that Ganoderma lucidum may offer supportive benefits for immune function in cancer patients. A 2016 Cochrane meta-analysis of five RCTs involving 373 cancer patients found that supplementation with G. lucidum extract, typically at doses of 1.4–5.4 g/day for 4–12 weeks alongside conventional treatments, significantly improved immune response indicators, including increased the percentage of CD4+ T cells by 3.05% (95% CI 1.00% to 5.11%) and CD8+ T cells by 2.02% (95% CI 0.21% to 3.84%). This suggests potential immune-modulating effects, though the analysis noted high risk of bias in included studies due to poor methodological quality. A pilot RCT in 48 breast cancer patients undergoing endocrine therapy demonstrated that 3 g/day of G. lucidum spore powder for 4 weeks reduced cancer-related fatigue scores by approximately 18% on the FACT-F scale (from 39.76 to 46.78) and improved overall quality of life, with no serious adverse events reported. Regarding cardiovascular health, human trials have yielded mixed results on profiles, with some evidence of modest improvements in . Doses in such trials typically range from 1.5 to 9 g/day of dried extract. However, a 2025 meta-analysis of 17 RCTs (n=971) found no overall significant effects on LDL-C (WMD −0.13 mmol/L, 95% CI −0.34 to 0.08), , or , attributing inconsistencies to variations in extract type, duration (1–24 weeks), and participant characteristics like . Evidence quality remains low, limiting firm conclusions on cardiovascular benefits. As an adjunct in cancer , G. lucidum shows promise for symptom management but not for extending survival. The same 2016 Cochrane reported a modest improvement in tumor response rates (RR 1.27, 95% CI 1.03–1.57) when combined with or radiotherapy, alongside enhanced immune parameters, showed relatively improved compared to controls in four studies, though the is of low due to methodological limitations, or one-year survival. In the aforementioned pilot trial, improvements were linked to reduction, supporting its role in alleviating side effects. No large-scale trials have demonstrated survival extensions, and benefits appear confined to supportive care. Despite these findings, clinical evidence for G. lucidum is constrained by small sample sizes (often n<100 per trial), heterogeneous preparations, and short durations, with most studies originating from and exhibiting methodological limitations like inadequate blinding. As of 2025, larger Phase III trials are needed to confirm efficacy, particularly for immune support and adjunctive anticancer use, and to standardize dosing and extract .

Safety and regulation

Potential risks

Common side effects of Ganoderma lucidum supplementation at standard doses, typically 1-9 grams per day in clinical contexts, include dry mouth, , and , occurring in less than 5% of participants across multiple trials. Recent toxicological studies from 2024-2025 have confirmed low acute and subchronic , no , and overall rarity of adverse effects for both fruiting body and mycelial preparations. In one involving 84 participants with , mild adverse events such as dry mouth, , and were reported in the intervention group at rates similar to , with no serious events attributed to the . A Cochrane of five trials for found minimal side effects, primarily and , with no significant hematological or hepatological observed. Ganoderma lucidum may interact with medications such as , potentially increasing the risk of due to its antiplatelet and effects. Case reports document elevated international normalized ratio (INR) levels in patients concurrently using the supplement and , leading to enhanced activity. This interaction arises from the mushroom's influence on platelet aggregation and , warranting of parameters in at-risk individuals. Rare cases of have been associated with Ganoderma lucidum use, particularly in the 2010s, including reports of elevated liver enzymes and , with no new cases documented in 2024-2025. For instance, a 2022 case described cholestatic in a consuming a G. lucidum extract, resolving after discontinuation. Another 2023 report detailed in a 47-year-old with significantly raised transaminases following prolonged , confirmed as supplement-induced upon exclusion of other causes. Earlier, a 2007 case reported fatal linked to a G. lucidum preparation, though confounded by . These incidents highlight the potential for idiosyncratic liver reactions, though overall incidence remains low in clinical populations, and recent suggests hepatoprotective potential in some models. Additionally, consumption may pose low risks from potentially toxic elements such as accumulated from substrates, particularly in regions like Longquan, , though overall exposure in the general is assessed as minimal. Use of Ganoderma lucidum is contraindicated in pregnant women due to insufficient safety data from human studies. Similarly, individuals with autoimmune disorders should avoid it, as the mushroom's immunostimulatory properties may exacerbate conditions by enhancing immune responses. Caution is advised for these vulnerable groups to prevent potential adverse outcomes. In the United States, Ganoderma lucidum is classified and marketed as a under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which does not require premarket approval by the (FDA) for safety or efficacy claims, provided the product is labeled appropriately and manufactured under good manufacturing practices. The FDA monitors for adulteration and misleading claims, issuing warning letters to companies making unapproved disease treatment assertions, but the ingredient itself faces no outright . In , Ganoderma lucidum holds official status as a (TCM) herb, with cultivation regulated under (GAP) guidelines issued by the State Food and Drug Administration to ensure quality and standardization of medicinal materials. Over 1,000 health food products containing G. lucidum have received government certification, reflecting its integration into the national regulatory framework for TCM. Within the European Union, the dried fruiting body of Ganoderma lucidum is not classified as a novel food, as it demonstrates a history of safe consumption prior to May 15, 1997, allowing its use in food supplements without additional authorization. Extracts such as powder from the fruiting body have similarly been confirmed as not novel in recent consultations (e.g., February 2025 by Finnish authorities). However, dehydrated mycelium powder is considered a novel food under Regulation (EU) 2015/2283, requiring premarket safety assessment and authorization before market placement; for instance, unauthorized mycelium products have been flagged in EU alerts as of 2024. Globally, Ganoderma lucidum faces no major bans or widespread restrictions, though pharmacopeial standards, such as those in the , include identification tests like to detect adulteration with inferior species or contaminants, ensuring product integrity in commercial and medicinal applications.