is ashwagandha banned in europe?

in denmark, yes: the danish veterinary and food administration says ashwagandha may not be sold as food or in supplements, on the basis of a may 2020 risk assessment by the technical university of denmark that found effects on sex hormones, reproduction, thyroid hormones and the nervous and immune systems in the available studies and concluded no safe intake could be set. the netherlands (march 2024) and france (april 2024) did not ban it but advised against it: the dutch institute advises consumers not to use it, especially in pregnancy, and the french agency advises people with thyroid, liver or heart disease, pregnant and breastfeeding women, people under 18 and people on sedatives to abstain. belgium and italy allow the whole plant in supplements without special conditions, and france had itself listed it as permitted in 2019.

can ashwagandha damage your liver?

it has, in published cases. five patients in iceland and the us drug-induced liver injury network developed jaundice 2 to 12 weeks after starting ashwagandha-containing supplements, with itching and high bilirubin lasting 5 to 20 weeks; the products were analysed and contained ashwagandha and no other toxic compound. nobody developed liver failure and liver tests normalised within 1 to 5 months in the four followed up. the nih’s livertox database lists ashwagandha as an implicated agent, and the dutch and french food-safety agencies cite physician reports of liver injury in their own countries. five cases cannot say how often it happens.

is ashwagandha safe in pregnancy?

no regulator on this page says it is. the danish assessment cites the root’s traditional use to induce abortion and the world health organization’s advice against it in pregnancy and breastfeeding; the dutch institute advises against use in pregnancy as a precaution, noting the effect has never been studied; the french agency lists pregnant women among the people who should abstain and adds breastfeeding women as a precaution. the trials on this page excluded pregnant women, so there is no trial evidence either way.

is ashwagandha fda approved?

no. in the united states it is a dietary supplement under the 1994 dietary supplement health and education act, so the fda does not review it for safety or effectiveness before sale, does not verify the extract or dose in the bottle, and has never approved it for stress, anxiety, depression or anything else; manufacturers may make only non-disease "structure/function" claims. the branded extracts in the trials (ksm-66, sensoril, shoden) are different preparations with different withanolide content, so a trial of one says nothing about another.

Supplement evidence

Ashwagandha

The anxiety and stress trials, and the liver-injury reports.

page first published 2026-09-08 · last updated 2026-10-05

Not an FDA-approved treatmentSold as a dietary supplement5 studies on this page

What Its Legal Status Actually Means

Read this before anything below it. Legal to sell is not the same fact as reviewed, verified, or approved.

Ashwagandha is sold in the US as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA). That means the FDA does not review it for safety or effectiveness before sale, does not verify that a bottle contains the amount or the extract named on the label, and has never approved it to prevent, treat, or cure any condition — including stress, anxiety, or depression. Manufacturers may only make non-disease "structure/function" claims. The branded extracts that dominate the research literature (KSM-66 from Ixoreal Biomed, Sensoril from Natreon, Shoden from Arjuna Natural) are proprietary preparations that differ in root-versus-leaf source, withanolide concentration, and dose, so trial results for one product do not automatically transfer to another bottle on the shelf.

Quoted whole from the 2026-08-18 study harvest. Not summarized, not shortened.

does ashwagandha work for anxiety? what the trials, the liver reports and the regulators say

there is no fda label for ashwagandha, because in the united states it is sold as a dietary supplement and has never been reviewed for safety or effectiveness. the us regulatory facts below come from the legal-status paragraph above, written from the regulator’s documents in the 2026-08-18 study harvest; the danish, dutch and french facts are read from those agencies’ own documents, linked at the end; every trial figure is from a study record on this page. every source is linked at the end of this section. last checked 2026-10-05.

ashwagandha, the root of withania somnifera, is sold in the united states for stress, anxiety and sleep, and it is one of the most-searched supplements on this site. the evidence has three parts that do not point the same way: a stack of small, short trials, most of them run on a manufacturer’s own extract, reporting effects larger than any prescription anxiety drug achieves; a case series of liver injury from iceland and the us national institutes of health’s liver-injury network; and, since 2020, a run of european regulators who looked at the same literature and concluded they could not set a safe intake. this section covers each, in both directions, with the funders named. every figure is from a study record on this page or from a regulator document linked at the end.

this is information to take to a prescriber or pharmacist. nothing here tells anyone to take ashwagandha or to stop, and nothing here is a reason to put off treatment that works for anxiety.

what its legal status means, and does not mean

in the united states ashwagandha is sold over the counter as a dietary supplement under the 1994 dietary supplement health and education act. the fda does not review it for safety or effectiveness before sale, does not verify that a bottle contains the amount or the extract named on the label, and has never approved it to prevent, treat or cure any condition, including stress, anxiety or depression; manufacturers may make only non-disease "structure/function" claims [status]. the branded extracts that dominate the trial literature, ksm-66 from ixoreal biomed, sensoril from natreon and shoden from arjuna natural, are proprietary preparations that differ in root-versus-leaf source, withanolide content and dose, so a result for one does not transfer to another bottle on the shelf [status].

three european food-safety agencies have looked at the same plant and reached a different posture. denmark first: the danish veterinary and food administration asked the technical university of denmark’s national food institute for a risk assessment of the root, delivered on may 15, 2020. it found experimental studies showing effects on sex hormones and reproduction in rats, reports of the root’s use to induce abortion (the world health organization advises against it in pregnancy and breastfeeding for that reason), animal studies showing effects on thyroid hormones with some human studies and adverse-event reports pointing the same way, inhibition of acetylcholinesterase in test-tube and rat studies, and effects on the immune system, and it concluded that on the available data no intake of the root or its extracts could be set below which there would be no risk of harmful effects [dtu-2020]. the administration’s position since is that ashwagandha may not lawfully be sold as food or in food supplements in denmark [dvfa]. the netherlands next: the national institute for public health and the environment, assessing it for the health ministry in a letter report published march 8, 2024, found that the human studies, which mostly looked for benefits, reported no harm, but that physicians in the netherlands and elsewhere had reported intoxications, with harmful effects on the liver and on thyroid hormone and cortisol concentrations, in people taking amounts similar to those in dutch supplements; it advises consumers not to use ashwagandha products, especially in pregnancy [rivm-2024]. france last: the french agency for food, environmental and occupational health and safety, in an opinion dated april 19, 2024, recorded eight adverse-event reports to its nutrivigilance scheme since 2009, six of them analysed for causality, including liver effects (jaundice) and psychiatric effects; it said its findings "share the conclusions" of germany in 2012, denmark in 2020 and the netherlands in 2024 on "the impossibility of defining a risk-free level of consumption because of the insufficient quality of the available data", and it recommended that people with thyroid, liver or heart disease, hyperandrogenism, pregnant women, and anyone on a sedative or other central-nervous-system depressant abstain from supplements containing it, with breastfeeding women and people under 18 added as a precaution [anses-2024].

the other direction, from the same documents. france had accepted the plant onto its list of permitted supplement botanicals in 2019 without particular restriction, and the french opinion notes that belgium and italy allow the whole plant in supplements without special conditions [anses-2024]. the danish assessment is of the root but, because the constituents overlap, it drew on studies of other plant parts, and it says plainly that the data do not allow it to identify which substance in the plant causes the reported effects [dtu-2020]. the dutch report says the human trials found no harm and that it does not know which people are sensitive [rivm-2024]. none of the three agencies claims to have measured how often harm occurs; each says the data are too poor to set a safe dose, and acted on that.

what the trials measured, in whom, and for how long

two meta-analyses and two of the trials they rest on are on this page. the broad one is a bayesian network meta-analysis of 29 randomised trials of 12 medicinal herbs in adults with diagnosed or subthreshold anxiety, with ashwagandha one arm of the network [zhang-2022]. the narrow one pooled 12 randomised trials of ashwagandha in 1,002 people on anxiety and stress scales [akhgarjand-2022]. the two trials are the most-cited one, 64 adults with chronic stress taking 300 mg of ksm-66 root extract twice a day or placebo for 60 days [chandrasekhar-2012], and a 60-person trial of 240 mg of the shoden extract a day against placebo for 60 days in stressed but otherwise healthy adults [lopresti-2019].

what was not measured. the trials typically enrolled about 60 people for 8 to 12 weeks, most were run on manufacturer-supplied extract, and there is no trial in people with a diagnosed anxiety disorder or major depression treated to standard clinical endpoints [risks]. none tested the product a reader would buy for its content, and none was long enough to see the liver injury described below, which appeared 2 to 12 weeks after starting in people outside trials [bjornsson-2020].

what the research says, in both directions

in favour. in the network meta-analysis, ashwagandha reduced hamilton anxiety scale scores by 4.90 points against placebo (95% credible interval −9.70 to −0.17) [zhang-2022]. the pooled analysis of 12 trials reported large reductions in anxiety (standardised mean difference −1.55) and stress (−1.75) [akhgarjand-2022]. in the 64-person trial, the extract group scored lower on every stress scale (p < 0.0001) with lower serum cortisol (p = 0.0006) [chandrasekhar-2012]; in the 60-person trial, hamilton anxiety scores fell more on ashwagandha than placebo (p = 0.040) and morning cortisol dropped more [lopresti-2019].

against, or smaller than the badge suggests. the network meta-analysis’s own authors say all its results "should be considered preliminary because of the unconvincing sample sizes, together with the potential effectiveness of placebos", and the lower bound of the ashwagandha estimate almost touches zero [zhang-2022]. the pooled analysis rated the certainty of its own evidence low, and its heterogeneity was extreme (i-squared 93.8% for anxiety, 83.1% for stress); an effect of −1.55 is roughly three times the size seen for ssris in anxiety trials, which is the signature of small biased trials rather than of a drug no prescription anxiolytic has matched [akhgarjand-2022]. the 60-person trial’s broader stress and mood measure did not reach significance (p = 0.096) [lopresti-2019]. the 64-person trial was single-centre, not preregistered, in people who were stressed rather than diagnosed, with p-values implausibly uniform across every scale, and it has never been replicated at scale by an independent group [chandrasekhar-2012].

who paid. the network meta-analysis was funded by a chinese university and national science programmes, at an institute of chinese medicine [zhang-2022]; the pooled analysis’s funding could not be read [akhgarjand-2022]. the 60-person trial was funded by arjuna natural extracts, the manufacturer of the shoden extract it tested [lopresti-2019]. the 64-person trial declares "source of support: nil" while its own text says the ksm-66 extract was provided by ixoreal biomed, its manufacturer, which is in-kind industry support whatever the declaration says [chandrasekhar-2012]. the great majority of the trials in both meta-analyses were run on manufacturer-supplied branded extracts [akhgarjand-2022; zhang-2022]. the liver case series was funded by the us national institute of diabetes and digestive and kidney diseases, with no commercial sponsor [bjornsson-2020].

the liver, the thyroid, and pregnancy

five patients, mean age 43, in iceland and in the us drug-induced liver injury network developed jaundice with nausea, lethargy, itching and abdominal discomfort 2 to 12 weeks after starting supplements containing ashwagandha. the injury was cholestatic or mixed; itching and high bilirubin persisted for 5 to 20 weeks; chemical analysis confirmed ashwagandha in the products with no other toxic compound found. nobody developed liver failure, and liver tests normalised within 1 to 5 months in the four patients followed up [bjornsson-2020]. five cases cannot say how often this happens; they establish that it happens, and the nih’s livertox database now lists ashwagandha as an implicated agent [bjornsson-2020; risks]. the dutch and french agencies both cite physician reports of liver injury in their own countries [rivm-2024; anses-2024].

the thyroid question runs the other way from most supplement warnings: ashwagandha can raise thyroid hormone levels. a randomised trial in subclinical hypothyroidism reported increases in t3 and t4, and published case reports describe thyrotoxicosis and painless thyroiditis after use, which matters for anyone with thyroid disease or on levothyroxine [risks]; the danish assessment records the same effect in animals and signs of it in people, and the dutch report lists thyroid hormones and cortisol among the reported effects [dtu-2020; rivm-2024]. on pregnancy, the danish assessment cites the root’s traditional use as an abortifacient and the world health organization’s advice against it in pregnancy and breastfeeding, the dutch agency advises against use in pregnancy as a precaution, and the french agency lists pregnant women among the people who should abstain [dtu-2020; rivm-2024; anses-2024]. the harvest adds that its sedative and immune-modulating properties raise interaction concerns with sedatives, thyroid drugs and immunosuppressants [risks].

questions for a prescriber or pharmacist about ashwagandha

each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.

the trials were about 60 people for 60 days, in stressed but undiagnosed adults, mostly on a manufacturer’s own extract. does anything about the people studied match me, and what would you expect it to do?
liver injury appeared 2 to 12 weeks after starting in the published cases. should we check my liver tests before and after, and what symptoms, dark urine, itching, yellow eyes, should make me stop and call?
i have a thyroid condition or take levothyroxine. ashwagandha can raise thyroid hormone levels; does that change anything for me?
i am pregnant, trying to conceive or breastfeeding. three european regulators advise against it in pregnancy; what would you want to know first?
i take a sedative, a sleeping pill, a benzodiazepine or an antidepressant. the french agency says people on central-nervous-system depressants should abstain; what is the concern in my case?
the product i have names a branded extract, or does not say. does it state what part of the plant it is made from and how it was tested?
if i am taking it for anxiety that has lasted months, what treatment with evidence behind it should we be talking about instead or as well?

questions people ask

does ashwagandha work for anxiety?: the trials say yes and the trials are weak. a network meta-analysis of 29 herb trials found ashwagandha lowered hamilton anxiety scores by about 4.9 points, with a credible interval that almost touches zero, and its authors called all their results preliminary. a pooled analysis of 12 ashwagandha trials in 1,002 people reported very large effects but rated its own evidence low certainty, with extreme disagreement between trials. the trials are typically 60 people for 60 days, in stressed rather than diagnosed adults, mostly run on a manufacturer’s own extract, and there is no trial in people with a diagnosed anxiety disorder treated to standard endpoints.
is ashwagandha banned in europe?: in denmark, yes: the danish veterinary and food administration says ashwagandha may not be sold as food or in supplements, on the basis of a may 2020 risk assessment by the technical university of denmark that found effects on sex hormones, reproduction, thyroid hormones and the nervous and immune systems in the available studies and concluded no safe intake could be set. the netherlands (march 2024) and france (april 2024) did not ban it but advised against it: the dutch institute advises consumers not to use it, especially in pregnancy, and the french agency advises people with thyroid, liver or heart disease, pregnant and breastfeeding women, people under 18 and people on sedatives to abstain. belgium and italy allow the whole plant in supplements without special conditions, and france had itself listed it as permitted in 2019.
can ashwagandha damage your liver?: it has, in published cases. five patients in iceland and the us drug-induced liver injury network developed jaundice 2 to 12 weeks after starting ashwagandha-containing supplements, with itching and high bilirubin lasting 5 to 20 weeks; the products were analysed and contained ashwagandha and no other toxic compound. nobody developed liver failure and liver tests normalised within 1 to 5 months in the four followed up. the nih’s livertox database lists ashwagandha as an implicated agent, and the dutch and french food-safety agencies cite physician reports of liver injury in their own countries. five cases cannot say how often it happens.
does ashwagandha affect the thyroid?: it can raise thyroid hormone levels, which is the opposite of what most people expect from a calming supplement. a randomised trial in people with subclinical hypothyroidism reported increases in t3 and t4, published case reports describe thyrotoxicosis and painless thyroiditis after use, and the danish and dutch regulators both record thyroid-hormone effects among the reasons for their advice. anyone with thyroid disease or taking levothyroxine has a specific question to ask before taking it.
is ashwagandha safe in pregnancy?: no regulator on this page says it is. the danish assessment cites the root’s traditional use to induce abortion and the world health organization’s advice against it in pregnancy and breastfeeding; the dutch institute advises against use in pregnancy as a precaution, noting the effect has never been studied; the french agency lists pregnant women among the people who should abstain and adds breastfeeding women as a precaution. the trials on this page excluded pregnant women, so there is no trial evidence either way.
is ashwagandha fda approved?: no. in the united states it is a dietary supplement under the 1994 dietary supplement health and education act, so the fda does not review it for safety or effectiveness before sale, does not verify the extract or dose in the bottle, and has never approved it for stress, anxiety, depression or anything else; manufacturers may make only non-disease "structure/function" claims. the branded extracts in the trials (ksm-66, sensoril, shoden) are different preparations with different withanolide content, so a trial of one says nothing about another.

sources for this section

the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.

What the Research Shows

5 records from the 2026-08-18 harvest, each checked against PubMed and Europe PMC on that date. How a study was designed, how many people were in it, and who paid for it are printed above what it found, because those three facts decide how much the finding is worth.

Study 1 · 2022
- Meta-analysis of randomized trials
- Reputable journal
- Independently funded
strong80/100
Well-supported by good-quality research.
Read this first: The credible interval runs from -9.70 to -0.17, meaning the true effect could be near zero; the ashwagandha estimate rests on a handful of small trials, most of which were supplied or funded by extract manufacturers. The analysis was conducted at the Beijing Research Institute of Chinese Medicine, an institution with an institutional interest in herbal medicine generally, though its funding came from the university and Chinese national science programmes rather than from any supplement company.
A Bayesian network meta-analysis of 29 randomized trials covering 12 medicinal herbs in adults with diagnosed or subthreshold anxiety found Withania somnifera reduced Hamilton Anxiety Scale scores by 4.90 points (95% credible interval -9.70 to -0.17) — an estimate whose lower bound almost touches zero, drawn from trials the authors explicitly flagged as "limited by their small sample sizes." The authors' overall verdict was that all these results "should be considered preliminary because of the unconvincing sample sizes, together with the potential effectiveness of placebos."
Zhang W, Yan Y, Wu Y, et al. (2022). Medicinal herbs for the treatment of anxiety: A systematic review and network meta-analysis. Pharmacological Research. PMID 35378276.
How this record was checked
PubMed record 35378276 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, the 29-trial count, and the Withania somnifera estimate (MD -4.90, 95% CrI -9.70 to -0.17) confirmed verbatim from the abstract. Europe PMC core record fetched 2026-08-18 lists funders "Beijing University of Chinese Medicine" and "National Major Science and Technology Projects of China" and no commercial sponsor, hence funding INDEPENDENT.
Study 2 · 2022
- Meta-analysis of randomized trials
- 1,002 participants
- Reputable journal
- Funding not established
moderate68/100
Reasonable evidence with real limitations.
Read this first: An SMD of -1.55 is roughly three times the effect size seen for SSRIs in anxiety trials, which is implausible on its face; combined with I-squared of 93.8% and the authors' own "low certainty" GRADE rating, the pooled number should be read as a summary of a biased literature, not as an estimate of benefit. The great majority of the pooled trials were run on manufacturer-supplied branded extracts.
Pooling 12 randomized trials with 1,002 participants, this meta-analysis reported large reductions in anxiety (standardized mean difference -1.55) and stress (SMD -1.75) versus placebo. The authors themselves rated the certainty of that evidence as low, and the heterogeneity between trials was extreme (I-squared 93.8% for anxiety, 83.1% for stress) — effect sizes that large with disagreement that severe usually reflect small biased trials rather than a real drug effect of a size no prescription anxiolytic has ever matched.
Akhgarjand C, Asoudeh F, Bagheri A, et al. (2022). Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trials. Phytotherapy Research. PMID 36017529.
How this record was checked
PubMed record 36017529 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, N=1,002 across 12 trials, SMD values, I-squared values, and the "certainty of the evidence was low" statement confirmed verbatim from the abstract. Europe PMC core record fetched 2026-08-18 returned no grant or funding list, and the publisher page was not retrievable, so funding is recorded UNKNOWN rather than inferred.
Study 3 · 2019
- Randomized trial
- 60 participants
- Indexed journal
- Industry funded
- Preregistered
- Declared conflicts of interest
early signal50/100
Suggestive but preliminary. Not settled.
Read this first: Funded by Arjuna Natural Extracts Ltd, the manufacturer of the Shoden extract tested. The authors state the trial was independently managed by the site investigators and the lead author discloses prior funding from the same company for unrelated work, but the sponsor's commercial interest in a positive result is direct, and the study's own secondary psychological outcome (DASS-21) did not reach statistical significance.
Sixty stressed but healthy adults took 240 mg of a standardized ashwagandha extract (Shoden) or placebo daily for 60 days. Anxiety on the Hamilton Anxiety Rating Scale fell more with ashwagandha than placebo (p=0.040), but the broader DASS-21 stress and mood measure did not reach significance (p=0.096); morning cortisol dropped more on ashwagandha. This is a 60-person study in people without a psychiatric diagnosis, funded by the company that makes the extract.
Lopresti AL, Smith SJ, Malvi H, Kodgule R. (2019). An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore). PMID 31517876.
How this record was checked
PubMed record 31517876 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, N=60, the 240 mg Shoden dose, HAM-A p=0.040, DASS-21 p=0.096, and CTRI registration CTRI/2017/08/009449 confirmed verbatim from the abstract and its conflict-of-interest statement. Europe PMC core record fetched 2026-08-18 lists the funding agency as "Arjuna Natural Extracts Ltd", hence funding INDUSTRY and independent false.
Study 4 · 2012
- Randomized trial
- 64 participants
- Indexed journal
- Industry funded
- Declared conflicts of interest
early signal44/100
Suggestive but preliminary. Not settled.
Read this first: The paper's formal declaration reads "Source of Support: Nil" and "Conflict of Interest: None", but its own text states that the high-concentration full-spectrum extract tested "is the KSM-66 Ashwagandha extract, provided by Ixoreal Biomed, Hyderabad, India" — in-kind supply of the investigational product by its manufacturer, which is industry support whatever the declaration says. Recorded here as INDUSTRY on that basis. The trial was also not preregistered and the reported p-values are implausibly uniform across every scale.
The single most-cited ashwagandha trial: 64 adults with chronic stress took 300 mg of KSM-66 root extract twice daily or placebo for 60 days, and the extract group scored significantly lower on every stress scale (p<0.0001) with lower serum cortisol (p=0.0006). It is a 64-person, single-centre, 60-day study in people who were stressed rather than diagnosed, run on extract supplied by the company that sells it, and its results have never been replicated at scale by an independent group.
Chandrasekhar K, Kapoor J, Anishetty S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine. PMID 23439798.
How this record was checked
PubMed record 23439798 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, N=64, the 300 mg twice-daily dose, the 60-day duration, and the p-values confirmed verbatim from the abstract. Europe PMC full text (PMC3573577) retrieved 2026-08-18: the supported-by footnote reads "Source of Support: Nil" and the conflict footnote reads "Conflict of Interest: None", while the body text discloses the KSM-66 extract was provided by Ixoreal Biomed — both statements read directly, hence the INDUSTRY call and the contestedNote above.
Study 5 · 2020
- Case series
- 5 participants
- Reputable journal
- Independently funded
- Declared conflicts of interest
early signal53/100
Suggestive but preliminary. Not settled.
Five patients (mean age 43) developed jaundice with nausea, lethargy, itching, and abdominal discomfort 2 to 12 weeks after starting ashwagandha-containing supplements; the injury was cholestatic or mixed, itching and high bilirubin persisted for 5 to 20 weeks, and chemical analysis confirmed ashwagandha in the products with no other toxic compounds identified. No one developed liver failure and liver tests normalised within 1 to 5 months in the four patients followed up. Five cases cannot tell you how often this happens, but they establish that it happens.
Björnsson HK, Björnsson ES, Avula B, et al. (2020). Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver International. PMID 31991029.
How this record was checked
PubMed record 31991029 fetched via NCBI efetch 2026-08-18; title, authors, journal, year, DOI, the five cases, the 2-12 week latency, the R ratios 1.4-3.3, and the 1-5 month recovery window confirmed verbatim from the abstract. Europe PMC core record fetched 2026-08-18 lists NIDDK grants U01DK083020, U01DK100928, U01DK083027, U01/U24 DK065176 and no commercial sponsor, hence funding INDEPENDENT; the record's conflict statement reads "The authors have no conflicts of interest to declare."

The Risks

Nobody checks this purchase the way a prescription is checked. No prescriber reviews it against the rest of what you take, no pharmacist screens the interaction, and no regulator confirms the dose in the capsule before it is sold. That is why this section sits here at full length rather than as a footnote.

What the paragraph below covers:

Liver injury
Drug interactions
Fertility and pregnancy
Sedation

Ashwagandha has been implicated in clinically apparent liver injury: a case series from Iceland and the US NIH-funded Drug-Induced Liver Injury Network documented five patients who developed jaundice, itching, and cholestatic or mixed liver injury 2-12 weeks after starting ashwagandha-containing supplements, and the NIH LiverTox database now lists it as an implicated agent. It can raise thyroid hormone levels — a randomized trial in subclinical hypothyroidism reported increases in T3 and T4, and published case reports describe thyrotoxicosis and painless thyroiditis after use — which matters for anyone with thyroid disease or on levothyroxine. It is generally advised against in pregnancy, and its sedative and immune-modulating properties raise interaction concerns with sedatives, thyroid drugs, and immunosuppressants. The efficacy evidence is a stack of small (typically 60-person), short (8-12 week) trials, most of them run on manufacturer-supplied extract and reported with effect sizes far larger than any prescription anxiolytic achieves — a pattern that usually signals bias rather than a breakthrough. There is no trial evidence in people with a diagnosed anxiety disorder or major depression treated to standard clinical endpoints.

What Is Not Known

The boundaries of the section above, in the harvest’s own words. What it excluded, why, and where it looked and found nothing. An absence of evidence is not evidence of absence, and it is not evidence of benefit either.

What Was Left Out, and Why

Quoted from the harvest, where these notes sat above the study list rather than after it. Where a note says “below” it means the studies in the section above.

Salve 2019 (Cureus, PMID 32021735, doi 10.7759/cureus.6466) was verified end-to-end but omitted: it duplicates Chandrasekhar 2012 in design, size (n=60), and sponsor (the KSM-66 extract was "manufactured and gifted by Ixoreal Biomed Inc." per the paper's own text), and adds nothing the two entries below do not already show.
Pratte 2014 (J Altern Complement Med, PMID 25405876) was verified but omitted as superseded by the two 2022 meta-analyses below; its own conclusion — "all studies exhibited unclear or high risk of bias" — is preserved in the contestedNotes here.
Lopresti 2019 in Am J Mens Health (PMID 30854916, aging overweight men) excluded: the outcome was hormones/vitality, not a mental-health endpoint.
Individual ashwagandha hepatotoxicity and thyrotoxicosis case reports (e.g. PMID 16355578, PMID 38559552) excluded in favour of the DILIN/Iceland case series below, which is the better-characterised source.

The Retraction Check

PubMed efetch records for all five PMIDs inspected 2026-08-18 for "Retraction in", "Expression of concern", "Erratum in", and "Withdrawn" flags; none present.

Questions for a Prescriber or Pharmacist

This page does not tell anyone to take Ashwagandha or to avoid it. It is not able to: it does not know what else you take, what you have tried, or what you are treating. These are the questions each study above raises, written to be asked out loud.

The best network meta-analysis puts ashwagandha's anxiety benefit somewhere between almost nothing and about 10 points on a clinical scale — is that uncertain a bet worth taking before we try something with firmer evidence?
This meta-analysis reports an anxiety effect bigger than anything prescription medication achieves, but rates its own evidence as low certainty — what would you want to see before treating that number as real?
This trial was paid for by the company selling the extract and ran for 60 days in 60 people without a diagnosed anxiety disorder — does anything about my situation match the people who were actually studied?
Most of what I've read about ashwagandha traces back to one 64-person study using one company's extract — is there anything larger or independent you'd want to see first?
If I take ashwagandha, should we check my liver enzymes before I start and again after a couple of months, and what symptoms should make me stop and call you?

And the one to ask at the counter, whatever the answers above turn out to be: given everything I am already taking, what would you want to know about Ashwagandha before I put it in the same body?

Open Ashwagandha in veisund

The app has the resources behind this page and people working through the same questions.What you post there goes to people, not to a model. If someone answers, it is a person who has been there. The one automated message is a crisis-resource reply.

Where This Page Comes From

Transcribed from the study-harvest-2026-08-18 record for ashwagandha, built into this page by scripts/supplement-ingest.mjs on 2026-09-07. Nothing here is fetched at page load, and nothing here was written by a model without a citation behind it.

Source file	study-harvest/2026-08-18/ashwagandha.yaml
Source repo	REPTechnologies/avalo-backend
SHA-256	1faca3fe747dcd96593eeb9698184e4a770f39206d92236b4aecc87ca636df77
Also searched as	Withania somnifera, KSM-66, Sensoril, Shoden, Indian ginseng, winter cherry, ashwagandha root extract

The Other Substances

Do any supplements actually work? asks the question across all of them. The full library has the medication records, the funding investigations, and the glossary.