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Lion's mane: contraindications and side effects reported in research

Soplówka jeżowata przeciwwskazania: what research reports about lion's mane side effects, who should be cautious, and when to check with a doctor first.

Mateusz Rosa

TCM therapist · Doctor of Acupuncture (WFAS) · author of a book on functional mushrooms

4 min read

Lion's mane: contraindications and side effects reported in research
Contents

Soplówka jeżowata przeciwwskazania: known in English as lion's mane, it is studied mainly for mild stomach discomfort, occasional headaches and rare allergic reactions, though a 2025 systematic review notes that adverse events are typically underreported in the literature. Be cautious with a mushroom allergy, pregnancy, breastfeeding, and prescription medication, and check with a doctor first.

What do studies actually report about side effects?

The 2025 systematic review by Menon et al. gathered 26 papers on lion's mane as a supplement, including 5 randomized human trials (PMID: 40959699). The authors describe reported mild stomach discomfort and headaches as the most common findings.

They state plainly, though, that safety documentation in the literature is incomplete, adverse events are sometimes simply not reported in publications. That's a data gap, not proof of complete safety.

Who should be especially cautious with lion's mane?

The studies in our review contain no data on children or on people with thyroid conditions, including Hashimoto's; no data does not mean safety, so in these groups the decision to supplement is best discussed with a doctor, especially since reactions can differ between individuals.

Three groups should talk to a doctor before starting: people with a mushroom allergy (lion's mane is a mushroom, so cross-reactivity is possible), pregnant and breastfeeding women (no safety studies for this group appear in our literature review), and people on anticoagulants or diabetes medication, due to theoretical interactions described in lab and animal studies. More detail on specific medications is in our separate post on lion's mane interactions.

What the studies checked

The table below lines up the three studies cited in this post: type, sample size, exactly what was checked for safety, and the PMID to verify the source. The Menon et al. row is a systematic review covering the other two clinical trials, so read it alongside the paragraphs above.

study (author, year)typein whomwhat it checkedPMID
Menon et al., 2025systematic review26 papers, 5 RCTsbenefits, side effects and uses of lion's mane as a supplement40959699
Mori et al., 2009placebo-controlled RCT30 people, aged 50-80cognitive-scale score after 16 weeks of 3 g/day, no serious events reported18844328
Li et al., 2020pilot RCT49 randomized, 41 completedsafety parameters over 49 weeks of erinacine-A-enriched mycelium32581767

What these studies don't tell you

None of the studies cited was designed purely to assess safety in a large sample or over many years, so rare adverse events may simply not have been captured. The results come from specific populations (Japan, older adults or healthy adults), not everyone who might take the supplement.

FAQ: frequently asked questions

Does lion's mane have serious side effects? No serious adverse events were reported in the studies cited, but the 2025 systematic review notes that safety reporting in the literature is incomplete. Talk to a doctor if you notice concerning symptoms.

Can someone with a mushroom allergy take lion's mane? Not without checking with a doctor or allergist first. Lion's mane is a mushroom, so cross-reactivity with another known mushroom allergy is possible.

Is lion's mane safe during pregnancy? Our literature review found no safety studies covering pregnancy or breastfeeding. That absence of data is a reason for caution and a conversation with your doctor, not a reason to decide alone.

More on the species is on the lion's mane page, and product details are on the lion's mane product card. What the research actually looked at is covered in the post on lion's mane study areas, and study doses are listed in the post on lion's mane dosage.


This content is for educational purposes only and does not constitute medical advice. A food supplement does not replace a varied diet or a healthy lifestyle. If in doubt, consult your doctor or pharmacist.

Lion's mane in scientific research

What was studied, on how many people and with what level of evidence. This overview describes studies, not the effects of a product.

8

human studies

6

placebo-controlled RCTs (incl. 1 pilot)

19912026

years of publication

  • Menon A. et al., 2025

    B

    systematic review

    26 studies, including only 5 RCTs · number of people: not reported

    The review collected studies on the use of Hericium erinaceus as a supplement in the context of cognitive function and reported adverse effects. The authors noted that adverse effects are usually not reported in the literature.

    PMID 40959699
  • Mori K. et al., 2009

    C

    RCT, double-blind, placebo-controlled

    30 people, 50 to 80 years, Japan

    The study examined the effect of taking Hericium erinaceus on a cognitive function scale score in a group of 30 Japanese people aged 50 to 80 with mild cognitive impairment. Very small sample from a single population, the differences faded within 4 weeks after discontinuation.

    PMID 18844328
  • Nagano M. et al., 2010

    C

    RCT, double-blind, placebo-controlled

    30 women

    The study examined the effect of 4 weeks of Hericium erinaceus intake on questionnaire scores for mood, perimenopausal symptoms and sleep quality in a group of 30 women. Very small sample, women only.

    PMID 20834180
  • Saitsu Y. et al., 2019

    C

    RCT, double-blind, placebo-controlled

    not reported

    The study examined the effect of 12 weeks of taking a Hericium erinaceus fruiting-body supplement on cognitive function test results in a group of adult participants. The authors noted that evidence regarding human health remains uncertain.

    PMID 31413233
  • Li I.C. et al., 2020

    D

    pilot RCT, placebo-controlled

    49 randomised, 41 completed

    The study examined the effect of 49 weeks of taking erinacine A-enriched Hericium erinaceus mycelia on cognitive test results and safety parameters in patients with mild Alzheimer's disease. Small, pilot sample size, larger studies needed.

    PMID 32581767
  • Docherty S. et al., 2023

    D

    pilot RCT

    41 healthy adults

    The study examined the effect of a single dose and 28 days of Hericium erinaceus supplementation on cognitive test results, perceived stress and mood in a group of 41 healthy adults. Small sample, null results alongside positive ones, replication needed.

    PMID 38004235
  • Surendran G. et al., 2025

    C

    crossover RCT, placebo-controlled, single dose

    18 healthy adults

    The study examined the effect of a single dose of a standardised Hericium erinaceus fruiting-body extract on cognitive test results and mood measured 90 minutes after administration in a group of 18 healthy young adults. Very small sample requiring replication.

    PMID 40276537
  • Spangenberg E.T. et al., 2025

    E

    systematic review of preclinical studies · preclinical studies (in vitro and rodent)

    not applicable, 23 studies

    The review collected preclinical studies (in vitro and in rodents) on the role of erinacines in neuroprotection models. No standardisation of erinacine measurement, inconsistent reporting of strains and extraction methods.

    PMID 40626304
  • Kawagishi H. et al., 1991

    E

    compound isolation + in vitro test · preclinical studies (in vitro and rodent)

    not applicable

    The study examined, through compound isolation from the fruiting body and an in vitro test, which substances (hericenones C, D, E) stimulate nerve growth factor (NGF) synthesis. Historical chemistry paper (1991).

    DOI 10.1016/0040-4039(91)80039-9
  • Friedman M., 2015

    E

    narrative review · preclinical studies (in vitro and rodent)

    not applicable

    The narrative review collected data on the chemical composition, nutritional value and reported health properties of lion's mane. The author emphasises that many properties come from preclinical studies.

    PMID 26244378
  • Lai P.L. et al., 2013

    E

    in vitro · preclinical studies (in vitro and rodent)

    not applicable

    The study examined the effect of an aqueous extract on nerve fibre outgrowth in an in vitro cell culture, alone and combined with NGF. The preparation did not protect cells from oxidative damage despite its neurotrophic effect.

    PMID 24266378
  • Nakatsugawa M. et al., 2003

    D

    case report, safety

    1 patient, 63-year-old man

    The case report documented acute respiratory failure (pneumonitis) in a 63-year-old man after taking a lion's mane extract 4 months earlier. Single case, safety data, not an efficacy study.

    PMID 14714963
  • Daoust J. et al., 2026

    C

    RCT, double-blind, placebo-controlled (preprint, not peer-reviewed)

    109 people (57+52), 40-75 years, 8 weeks

    The study (preprint, not peer-reviewed) examined the effect of 8 weeks of 2 g daily fruiting-body and mycelium biomass supplementation on visual attention, working memory, sleep quality and mood tests in 109 adults aged 40-75 with reported cognitive difficulties. The authors themselves describe the results as "modest". Preprint status means no scientific peer review.

    DOI 10.64898/2026.04.13.26350781
  • Cornford N., Charnley M., 2025

    E

    narrative review · preclinical studies (in vitro and rodent)

    not applicable (3 human studies + 13 animal studies discussed in the review)

    The narrative review analysed 3 human clinical studies and 13 animal studies on the prevention and delayed progression of Alzheimer's disease. The authors point to the need for additional human clinical studies.

    DOI 10.1017/S0954422425000058

Evidence levels: A · Cochrane review · B · systematic review · C · placebo RCT · D · pilot RCT · E · preclinical studies

What these studies don't say

  • Samples are usually small, most from a single population.
  • Results describe research interventions, not a dietary supplement.
  • The presence of a study is not a health claim.
  • 1 entry/entries are case reports about safety, not efficacy studies.

Source: Aloha Fungi literature review, 1 September 2026; entries verified via PubMed or by DOI (Crossref). See the research

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