✓ No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
📰Read the full Milk Thistle evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.⚠ Amanita phalloides mushroom poisoning — IV silibinin is the specific antidote. Contact poison control immediately [2]
⚠ Patient on warfarin + milk thistle — CYP2C9 inhibition may increase INR [2]
⚠ Standard silymarin has low bioavailability — Siliphos formulation preferred [2]
⚠ Patient with NAFLD — modest evidence supports silymarin for liver enzyme improvement [2]
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
ALT, AST
ALT, AST
Reference range / target
Normal range
Normal range
Improvement in transaminases expected with effective liver support [2].
Full lab monitoring ↓⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Milk thistle (silymarin) is the most studied hepatoprotective botanical — IV silibinin is literally life-saving for death cap mushroom poisoning. For everyday liver support, evidence is mixed: positive for NAFLD and alcoholic liver disease in some trials, negative for HCV (SyNCH). Siliphos formulation has 4–10× better bioavailability than standard extract. Commission E approved for toxic liver damage [1] [2] [3].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Generally considered safe. Traditional galactagogue use. Limited formal safety data [1].
👦 Pediatric: See guidance
Limited data. Used traditionally in pediatric liver conditions. No formal dosing guidelines [1].
🏃 Athletes: Standard dose
⚖️ 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: 140 mg TID with meals (standard extract). Siliphos: 120–240 mg BID [2].
💊 With food: Take with food for better tolerance and absorption [2].
🚫 Avoid: CYP2C9-metabolized drugs without monitoring [2].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['Standardized silymarin extract (70–80% silymarin)', 'common', 'Standard supplemental form. 140 mg TID. The extract used in most clinical trials [2].'] | Standard | Check label | |
| ['Silybin-phosphatidylcholine complex (Siliphos/Silipide)', 'preferred', 'Dramatically improved bioavailability (4–10× standard silymarin). Lower dose needed. Better studied in newer trials [2].'] | Standard | Check label | |
| ['IV silibinin (Legalon SIL)', '', 'Hospital use for Amanita phalloides (death cap mushroom) poisoning. The only setting where milk thistle has a clear life-saving role [2].'] | Standard | Check label |
3 Common questions
Does milk thistle actually protect the liver? ▼
The biological mechanisms are well-established (antioxidant, anti-inflammatory, antifibrotic, regenerative). Clinical trial results are mixed: some trials in alcoholic liver disease and NAFLD are positive, while the SyNCH trial in hepatitis C was negative [2] [3]. The strongest evidence is for Amanita poisoning (IV silibinin).
Can milk thistle reverse liver damage? ▼
Animal studies show hepatocyte regeneration. Human evidence suggests improvement in liver enzymes and steatosis but not reversal of established cirrhosis [2]. It is better positioned for protection and early-stage support than reversal of advanced disease.
Does silymarin have low bioavailability? ▼
Yes — standard silymarin is only 20–50% absorbed. Silybin-phosphatidylcholine (Siliphos) improves bioavailability 4–10 fold [2]. The Siliphos formulation is preferred when available.
Is milk thistle the antidote for death cap mushrooms? ▼
Yes — IV silibinin (Legalon SIL) is the specific antidote for Amanita phalloides poisoning. It must be given within 48 hours, ideally within 24 hours. Contact poison control immediately for access to the IV formulation [2].
4 Clinical evidence
Strong
Amanita phalloides poisoning: IV silibinin is the standard antidote, reducing mortality from ~30% to ~10% when given within 48 hours of death cap mushroom ingestion [2]. Hepatocyte membrane stabilization and regeneration are well-established pharmacologically [2]. HIGH
Moderate
Alcoholic liver disease: some trials show improved liver enzymes and histology. The SyNCH trial (n=154) was negative for primary endpoint in hepatitis C [3]. NAFLD: several small RCTs show reduction in liver enzymes and steatosis [2]. Hepatitis C: mixed results; some trials positive for viral load reduction when combined with standard therapy [2]. Type 2 diabetes: silymarin reduced HbA1c by ~1% in a small RCT of diabetics with liver disease [2]. MODERATE
Insufficient
5 Safety, toxicity & adverse events
Relative
⚠ Concurrent CYP3A4/CYP2C9 substrates — potential interaction (clinical significance unclear, but monitor warfarin, statins)
⚠ Hormone-sensitive conditions — silymarin has weak estrogenic activity at high doses
⚠ Ragweed/daisy/marigold allergy — cross-reactivity (Asteraceae family)
⚠ Concurrent diabetes medications — silymarin may enhance hypoglycemia
🚩 Red flags
● Death cap mushroom ingestion — IV silibinin emergency; contact poison control [2]
● Ragweed-allergic patient starting milk thistle — cross-reactivity possible (Asteraceae family) [1]
● Patient on warfarin + milk thistle — CYP2C9 inhibition; monitor INR [2]
6 Interactions
Drug interactions
Warfarin / CYP2C9 substrates Moderate
Mechanism: Silymarin inhibits CYP2C9 in vitro. [2]
Effect: Potentially increased warfarin levels and INR. [2]
Action: Monitor INR within 1–2 weeks of starting milk thistle [2].
Diabetes medications Moderate
Mechanism: Silymarin may reduce blood glucose (improved insulin sensitivity, hepatic glucose effects). [2]
Effect: Additive glucose lowering; hypoglycemia risk. [2]
Action: Monitor blood glucose when adding milk thistle to diabetes regimen [2].
Supplement synergies
NAC · 600–1,200 mg/day NAC
Both support hepatic glutathione. Complementary hepatoprotective mechanisms [2].
Both support hepatic glutathione. Complementary hepatoprotective mechanisms [2].
Alpha-Lipoic Acid · 300–600 mg/day ALA
ALA + silymarin + NAC is the 'liver triad' — three complementary hepatoprotective antioxidants [2].
ALA + silymarin + NAC is the 'liver triad' — three complementary hepatoprotective antioxidants [2].
7 Regulatory
United States (FDA): Dietary supplement. No approved drug claims [1].
Germany (Commission E): Approved for toxic liver damage and as adjunctive therapy for chronic inflammatory liver disease [2].
European Union: EMA: 'well-established use' for toxic liver damage. IV silibinin: hospital drug for Amanita poisoning [2].
South Korea: Available as dietary supplement.
8 US supplement products
331
on-market products containing Milk Thistle (NIH DSLD)
Brands carrying Milk Thistle (169)
Click a brand to see its Milk Thistle products.
9 Frequently paired with
10 Cite this page
Vancouver: Pkhakadze G. Milk Thistle — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/milk-thistle/
APA 7th: Pkhakadze, G. (2026). Milk Thistle — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/milk-thistle/
📋 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: February 2027
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. "Milk Thistle — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/milk-thistle/ CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG