⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
⚠️
Major drug interaction. This ingredient has clinically significant drug interactions. See Drug Interactions below before use.
Upper Safe Limit
Avoid in pregnancy — may stimulate uterine contractions
PubMed Studies
56
PubChem CID
About
Withanolides modulate cortisol via HPA axis suppression; adaptogenic and anxiolytic properties
How it works (mechanism of action)
Increasingly popular in French pharmacies for stress, fatigue and cognitive function. Good safety profile at standard doses.
⚖️ Regulatory Status
⛔
SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
⛔
PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
⛔
NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
⛔
NL — Banned
NVWA prohibition (2004).
⛔
MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
⛔
PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
IT — Banned
Italian Ministry of Health — ephedra and ephedrine alkaloid supplements prohibited under EU Directive 2002/46/EC.
⛔
AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
⛔
SA — Banned
SFDA Saudi Arabia — ephedra and ephedrine alkaloid supplements prohibited. Controlled as prescription drug.
⛔
ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
SE — Banned
Livsmedelsverket Sweden prohibition aligned with EU Directive 2002/46/EC.
⛔
FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
⛔
EU — Banned
Internal use of comfrey banned in EU due to pyrrolizidine alkaloids causing hepatic veno-occlusive disease. Topical use only permitted.
⛔
ES — Banned
AEMPS Spain prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
DK — Banned
Banned (2023) — Danish Veterinary and Food Administration (DVFA). Liver toxicity and thyroid disruption reports. All preparations ordered off market.
⛔
DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
⛔
CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
⛔
BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
⛔
US — Banned
FDA issued warning letter against oral comfrey products. Contains pyrrolizidine alkaloids causing liver damage.
⚠️
IN — Restricted
CDSCO India (2004) — available only under prescription as pharmaceutical products.
⚠️
TH — Restricted
FDA Thailand — ephedrine controlled as pharmaceutical. Not permitted in food supplements.
⚠️
TW — Restricted
TFDA Taiwan — ephedrine controlled as pharmaceutical drug. Not permitted as health food ingredient. Products with ephedra claims require pharmaceutical registration.
⚠️
ZA — Restricted
SAHPRA (2004) — Schedule 2; pharmacist oversight required.
⚠️
KR — Restricted
MFDS South Korea (2003) — maximum dose restrictions. Not permitted for weight loss products.
⚠️
JP — Restricted
MHLW Japan (2003) — maximum dose limits; not permitted for weight loss marketing. Ephedrine controlled under pharmaceutical regulations.
⚠️
IE — Restricted
FSAI monitoring (2024) following Danish ban and hepatotoxicity reports. Products without adequate safety data may face withdrawal.
⚠️
HK — Restricted
Department of Health Hong Kong — ephedrine-containing preparations controlled as pharmaceutical products. Not permitted as health food supplements without pharmaceutical registration.
⚠️
GB — Restricted
MHRA (2004) — ephedrine alkaloid supplements restricted. Maximum doses apply under the Medicines Act.
⚠️
CN — Restricted
NMPA China — Ma Huang (ephedra) controlled. Ephedrine alkaloid content restrictions; not permitted for weight loss products. Export of ephedra controlled internationally.
💊
CA — Prescription only
DHEA is a controlled substance in Canada, available by prescription only.
💊
AU — Prescription only
DHEA is scheduled as a prescription-only medicine in Australia (Schedule 4).
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
📊 Effectiveness
Cortisol reduction
Evidence Grade A · 12 studies · n=1,400 · Meta-analysis available
Stress and anxiety
Evidence Grade B · 12 studies · n=847 · Meta-analysis available
Physical performance
Evidence Grade B · 8 studies · n=462
Sleep quality
Evidence Grade B · 5 studies · n=280
Testosterone levels
Evidence Grade C · 4 studies · n=198
Athletic performance
Evidence Grade B · 10 studies · n=800
Evidence grades: A=Strong RCT evidence · B=Good clinical trials · C=Limited trials · D=Preliminary/traditional
👥 Safety by Population
🚫 Contraindications & Warnings
Consult a healthcare professional before use if pregnant, breastfeeding, taking prescription medications, or if you have a medical condition. Keep out of reach of children.
💊 Drug Interactions (9)
🔴 Immunosuppressants
MajorImmunosuppressants
Management: AVOID in transplant patients on cyclosporine or tacrolimus.
🔴 Levothyroxine
MajorThyroid medications
Management: Contraindicated in thyroid disease. Monitor TSH.
🔴 Cyclosporine / Tacrolimus
MajorImmunosuppressants
Management: Contraindicated in transplant patients.
🟡 Thyroid medications
ModerateThyroid hormones
Management: Monitor thyroid function when starting or stopping Ashwagandha in patients on thyroid medication.
🟡 Diazepam / Alprazolam
ModerateBenzodiazepines
Management: Avoid combination. Monitor for excessive sedation.
🟡 Metformin / Insulin
ModerateAntidiabetics
Management: Monitor blood glucose closely.
⚪ Sedatives/benzodiazepines
MinorCNS depressants
Management: Use caution with CNS depressants. Avoid driving after taking high-dose Ashwagandha with sedatives.
⚪ Statins
MinorStatins
Management: Monitor LFTs.
⚪ Antihypertensives
MinorAntihypertensives
Management: Monitor BP.
⚠️ Adverse Effects (2)
Hepatotoxicity
very rare (case reports) Severe
Hepatic system
Rare case reports of liver injury. Possibly due to adulterants or excessive doses. Routine safety monitoring recommended.
Thyroid hormone increase
possible in hyperthyroid patients Moderate
Endocrine system
Stimulates thyroid hormone synthesis — beneficial in hypothyroidism but may worsen hyperthyroidism.
🏷️ Other Names
Withania somnifera
Sensoril
Ashwagandha root extract
Ashwagandha KSM-66
Withania
KSM-66
References (1)
- Pratte MA, et al. J Altern Complement Med. 2014;20(12):901-8. SR/Meta-analysis PubMed ↗
Evidence grades: SR = Systematic review / meta-analysis (highest) · RCT = Randomized controlled trial · Reg = Regulatory/official guidance