⚠ Banned in at least one country (DVFA) — see Regulatory alerts by country below.
⚠ Banned in Denmark (2023). France, Belgium issuing warnings. Counsel patients traveling to the EU [2].
⚠ Contraindicated in pregnancy — classified as potentially abortifacient in Ayurvedic texts.
⚠ Monitor TSH — case reports of both hypo- and hyperthyroid effects. Avoid in autoimmune thyroiditis [1].
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
Recommended test
TSH and free T4
TSH and free T4
Reference range / target
Monitor for TSH suppression and elevated free T4 indicating ashwagandha-induced thyroid stimulation [10]
Monitor for TSH suppression and elevated free T4 indicating ashwagandha-induced thyroid stimulation [10]
When to test
Hypothyroid patients starting ashwagandha; thyrotoxicosis symptoms; baseline before starting
Full lab monitoring ↓Hypothyroid patients starting ashwagandha; thyrotoxicosis symptoms; baseline before starting
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Cortisol reduction is well-demonstrated (5 RCTs, weighted mean difference: −11.3 ng/mL) with 300–600 mg/day root extract over 8–12 weeks [1]. Reasonable adjunct for stress and anxiety when SSRIs are declined or inadequate [3]. Root-only extracts preferred over root+leaf (lower withaferin A hepatotoxicity risk). Set patient expectations: onset requires 4–8 weeks.
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
👦 Pediatric: See guidance
Limited pediatric data. Some Ayurvedic tradition of use in children for growth and immunity, but no adequate clinical trials [7]. Not recommended for children under 12 without medical supervision. One
🏃 Athletes: Specific dosage data under clinical review
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: Can be taken morning or evening. For sleep: take with warm milk 30–60 minutes before bed. For anxiety/stress: morning or split dose AM/PM [6].
💊 With food: Take with food (preferably warm milk, per traditional use) to improve absorption and reduce GI discomfort. Withanolides are lipophilic — fat-containing meals may enhance absorption [7].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['KSM-66 root extract', 'preferred', 'Full-spectrum root extract standardized to ≥5% withanolides. Most clinically studied extract. 14+ RCTs. Gold-standard for anxiolytic and adaptogenic use [6].'] | Standard | Check label | |
| ['Sensoril (root + leaf extract)', '', 'Standardized to ≥10% withanolides (higher concentration from combined root+leaf). Studied for cortisol reduction and anxiety. Different withanolide profile than KSM-66 [6].'] | Standard | Check label | |
| ['Root powder (churna)', 'common', 'Traditional Ayurvedic form. Lower withanolide concentration than standardized extracts. Used at higher doses (3–6 g/day). Often mixed with milk (ashwagandha milk) [7].'] | Standard | Check label | |
| ['Withania somnifera liquid extract', '', 'Hydroalcoholic tincture. Variable potency. Less studied than standardized extracts [7].'] | Standard | Check label |
3 Common questions
Why is ashwagandha banned in Denmark? ▼
Denmark banned ashwagandha in 2023 based on safety concerns including reports of liver injury (hepatotoxicity), thyroid dysfunction, and hormonal effects [2]. The Danish Veterinary and Food Administration concluded that insufficient safety data existed for long-term use. France, Belgium, and other EU countries have issued similar warnings or are reviewing the ingredient.
How long does ashwagandha take to work? ▼
Can ashwagandha affect thyroid function? ▼
Case reports describe both increases and decreases in thyroid hormone levels. Individuals with thyroid disorders (particularly hyperthyroidism or Hashimoto thyroiditis) should use ashwagandha only under medical supervision. Monitor TSH levels if using ashwagandha long-term [1].
What is the difference between KSM-66 and Sensoril? ▼
KSM-66 is a full-spectrum root extract standardized to 5% withanolides. Sensoril is a root-and-leaf extract standardized to 10% withanolides. Both are well-studied; KSM-66 has more published clinical trials. Root-only extracts are generally considered safer due to lower withaferin A content.
4 Clinical evidence
Strong
Cortisol reduction: a systematic review of 5 RCTs found a statistically significant reduction in serum cortisol (weighted mean difference: -11.3 ng/mL) with 300-600 mg/day of root extract over 8-12 weeks [1]. Anxiety reduction: a meta-analysis of 12 trials demonstrated significant improvement in anxiety scores (Hamilton Anxiety Rating Scale) compared with placebo [3]. HIGH
Moderate
Testosterone increase in men: two trials reported 10-22% increase in total testosterone with 600 mg/day KSM-66 over 8 weeks in infertile and healthy men [1]. Muscle strength and recovery: 600 mg/day improved bench press and leg extension strength in resistance-trained men over 8 weeks [1]. Sleep quality improvement: 300 mg twice daily improved sleep onset latency and quality in a 10-week RCT [1]. MODERATE
Insufficient
Thyroid function modulation: case reports suggest both hypo- and hyperthyroid effects; systematic evidence is absent [1]. Anti-cancer activity: preclinical data on withaferin A is promising but human trial data does not exist [1]. Cognitive enhancement in healthy adults: limited to one small trial [1]. LOW
5 Safety, toxicity & adverse events
Absolute contraindications
✕ Thyrotoxicosis/hyperthyroidism — ashwagandha increases T3/T4 via thyroid stimulation; can precipitate thyroid storm
Relative
⚠ Autoimmune diseases (lupus, RA, MS) — immunostimulatory effects may worsen flares
⚠ Pregnancy — traditionally classified as abortifacient; withaferin A shows embryotoxicity in animal studies
⚠ Concurrent thyroid medication — may require dose adjustment due to thyroid stimulation
⚠ Concurrent sedatives/benzodiazepines — additive CNS depression
⚠ Surgery — discontinue 2 weeks before due to CNS depressant and possible blood pressure effects
🚩 Red flags
● Pregnancy — CONTRAINDICATED due to possible abortifacient activity [9]
● Autoimmune disease (lupus, RA, MS, Hashimoto) — immunostimulation may trigger flares [9]
● Thyrotoxicosis symptoms (palpitations, weight loss, tremor) in patient taking ashwagandha — check TSH urgently [10]
● Elevated liver enzymes in ashwagandha user — discontinue immediately; rare hepatotoxicity reported [9]
● Transplant recipient or patient on immunosuppressants — avoid due to immune activation [9]
● Patient on levothyroxine with suppressed TSH — ashwagandha may be contributing to thyroid overstimulation [10]
6 Interactions
Drug interactions
Levothyroxine / thyroid hormones Major
Mechanism: Ashwagandha stimulates thyroid function by increasing serum T3 and T4 levels via hypothalamic-pituitary-thyroid axis modulation [10]. Can cause thyrotoxicosis in patients already on thyroid replacement.
Immunosuppressants Major
Mechanism: Ashwagandha enhances NK cell activity, increases CD4+ and CD8+ T-cells, and stimulates both innate and adaptive immunity [9]. May counteract immunosuppressive therapy.
Sedatives (benzodiazepines, zolpidem) Moderate
Mechanism: Withanolides modulate GABA-A receptors, producing anxiolytic and sedative effects. Additive CNS depression with pharmacological sedatives [6].
Antidiabetic medications (metformin, sulfonylureas, insulin) Moderate
Mechanism: Ashwagandha may reduce fasting blood glucose by 12–25% in some studies. Additive hypoglycemic effect [6].
7 Laboratory monitoring
TSH and free T4 Primary
Morning cortisol Secondary
Liver function tests (ALT, AST) Secondary
8 Regulatory
United States (FDA): Dietary supplement (DSHEA 1994). No FDA-approved drug claims. Classified as GRAS for food use. NDI notification may be required for novel extracts [7].
European Union (EFSA): Novel food status under discussion in some member states. Health claims not yet authorized by EFSA. Available as food supplement in most EU countries. Safety warnings issued by Iceland and Denmark regarding hepatotoxicity [9].
India (FSSAI/Ayush): Listed in Ayurvedic Pharmacopoeia of India. Traditional use documented for >3,000 years. Classified as rasayana (rejuvenating herb). KSM-66 and Sensoril are Indian-manufactured standardized extracts [7].
Australia (TGA): Listed medicine. Permitted indications include 'traditionally used to support stress adaptation' and 'maintain healthy sleep patterns' [7].
9 Regulatory alerts by country
10 regulatory actions on record — 6 with a verified source link, 4 with the official reference being verified.
Banned · 1
🇩🇰
DVFA — Banned April 2023 following DTU risk assessment. All products withdrawn.
Danish Veterinary and Food Administration (DVFA) banned ashwagandha in food supplements following the 2020 DTU risk assessment.
2023-01-01 · official reference being verified
Restricted · 2
🇧🇪
FASFC — Classified as medicinal product. Requires pharmaceutical authorization.
Belgium FASFC (AFSCA): ashwagandha restricted under the Belgian Royal Decree on plants in food supplements.
Source ↗ · 2024-01-01
🇵🇱
GIS — Permitted: max 3g root/day, max 10mg withanolides.
Poland GIS: ashwagandha root powder restricted (max 3 g / 10 mg withanolides; prohibited for children and pregnant/breastfeeding women).
Source ↗ · 2020-01-01
Warning · 4
🇫🇷
ANSES — Advises against use in food supplements for sensitive groups: pregnant/breastfeeding women, minors, and people with thyroid, liver or cardiac conditions. Not banned — re-authorised in supplements since 2015.
ANSES avis Saisine n° 2021-SA-0077 (19 April 2024): risks of Withania somnifera in food supplements; population-specific advice against use (échoes Denmark/Germany/Netherlands).
Source ↗ · 2024-04-19
🇩🇪
BfR — Concerns expressed. May be blocked by local health authorities.
Germany BfR risk assessment / consumer health opinion for this substance.
Source ↗ · 2024-01-01
🇳🇱
RIVM — Advisory March 2024: do not use, especially pregnant women. Liver/thyroid concerns.
Netherlands RIVM/NVWA advice against ashwagandha consumption for specific population groups.
2024-01-01 · official reference being verified
🇦🇺
TGA — Safety advisory 2024: potential GI symptoms, very rare liver injury.
TGA complementary-medicines requirements / mandatory label warnings and permitted-ingredient determinations.
Source ↗ · 2024-01-01
Under review · 3
🇪🇺
EU Heads of FSA — Article 8 procedure recommended (June 2024) for possible EU-wide restriction.
EU Heads of Food Safety Agencies / national food authorities reviewing this botanical under Reg (EC) 1925/2006 Art. 8.
Source ↗ · 2024-01-01
🇸🇪
Livsmedelsverket — Actively considering ban, referencing Denmark's assessment.
Sweden Livsmedelsverket: applies the Danish (DTU) ashwagandha risk assessment; case-by-case municipal enforcement.
2022-09-01 · official reference being verified
🇫🇮
Ruokavirasto — Under regulatory review.
Finland Ruokavirasto: ashwagandha under review applying the Danish (DTU) risk assessment.
2023-01-01 · official reference being verified
10 US supplement products
292
on-market products containing Ashwagandha (NIH DSLD)
Brands carrying Ashwagandha (181)
Click a brand to see its Ashwagandha products.
11 Frequently paired with
12 References (3)
[1]Bonilla DA, et al. Effects of Ashwagandha (Withania somnifera) on physical performance: systematic review and Bayesian meta-analysis. J Funct Morphol Kinesiol. 2021;6(1):20. doi:10.3390/jfmk6010020 META-ANALYSIS Accessed: 2026-05-29
[2]Danish Veterinary and Food Administration. Assessment of ashwagandha (Withania somnifera) — risk assessment. Copenhagen; 2023. www.foedevarestyrelsen.dk REVIEW Accessed: 2026-05-29
[3]Pratte MA, et al. An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha. J Altern Complement Med. 2014;20(12):901-908. doi:10.1089/acm.2014.0177 META-ANALYSIS Accessed: 2026-05-29
13 Related articles
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14 Cite this page
Vancouver: Pkhakadze G. Ashwagandha — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Jun 01]. Available from: https://www.ruokavirasto.fi/en/
APA 7th: Pkhakadze, G. (2026). Ashwagandha — Safety profile. Public Health Institute of Georgia. https://www.ruokavirasto.fi/en/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: December 2026
References: 3 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Ashwagandha — Safety Profile." SupplementIndex, PHIG, 2026. https://www.ruokavirasto.fi/en/ CC BY 4.0.
GP
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG