Supplements

Milk Thistle

Updated · 28 sources · Editorial policy

Milk thistle (Silybum marianum) is a flowering plant in the daisy family whose seed-like fruits contain silymarin, a mixture of flavonolignans. Silybin (also spelled silibinin) is its main component. Silymarin has been described as the most commonly used herbal product for chronic liver disease (Freedman et al., Aliment Pharmacol Ther 2011), and it is often marketed as “liver support” for people who take oral anabolic steroids.

The clinical evidence is much weaker than its reputation. A Cochrane review of 18 randomized trials found no significant effect on death, liver complications or liver histology in alcoholic or viral liver disease. Two NIH-funded US trials, in hepatitis C and in fatty liver disease, found no benefit on their primary endpoints. The strongest case for a medical use is intravenous silibinin for death-cap (Amanita) mushroom poisoning, which rests on uncontrolled case series. No human study has tested milk thistle in people using anabolic steroids.

This page summarizes what the clinical trials, systematic reviews and regulators report. It is for education only and is not medical advice.

Property Detail
Source Fruits (“seeds”) of Silybum marianum, Asteraceae (daisy) family
Active fraction Silymarin: silybin A and B, isosilybin A and B, silychristin, silydianin
Forms Oral standardized extracts; silybin–phosphatidylcholine complexes; IV silibinin (Legalon SIL) in Europe
Oral doses used in trials 140 mg three times daily up to 700 mg three times daily (2.1 g/day) of silymarin
IV silibinin dose (amatoxin poisoning) 5 mg/kg loading dose, then 20 mg/kg/day by continuous infusion
Half-life About 1–3 h for free flavonolignans and 3–8 h for their conjugates after a 600 mg oral dose
Main evidence gap No benefit on mortality or primary endpoints in large or high-quality liver trials
US status Sold as a dietary supplement; not FDA-approved as a drug; IV silibinin only under FDA investigational protocols
WADA status Not named on the 2026 Prohibited List

Related library pages: TUDCA, UDCA, ursodiol (UDCA) and NAC (N-acetylcysteine). These are other compounds often promoted for liver protection, each with its own evidence base.

What it is

Milk thistle is a tall plant with purple flowers, native to Europe and brought to North America by early colonists (NCCIH). The extract from its fruits is called silymarin. It is not a single compound but a mixture of flavonolignans (plant polyphenols built from a flavonoid joined to a lignan-like unit), with silybin as the main component (Abenavoli et al., Phytother Res 2018).

Name What it refers to
Milk thistle The plant, Silybum marianum
Silymarin The standardized flavonolignan extract of the fruits
Silybin / silibinin The main component of silymarin, itself a pair of isomers, silybin A and silybin B
Legalon A brand of standardized oral silymarin (Legalon 140) used in the US SyNCH trials
Legalon SIL An injectable, water-soluble form of silibinin (silibinin dihydrogen succinate, disodium salt)

The six main flavonolignans measured in human plasma studies are silychristin, silydianin, silybin A, silybin B, isosilybin A and isosilybin B (Wen et al., Drug Metab Dispos 2008). Reviews describe antioxidant, anti-inflammatory and antifibrotic effects, mostly from laboratory and animal studies (Abenavoli et al., Phytother Res 2018). Those preclinical effects have not translated into clear clinical benefit in most human trials, as shown below.

Pharmacokinetics and bioavailability

Silymarin is poorly absorbed and quickly converted to conjugates (glucuronides and sulfates) in the body. Key findings from human studies:

Study Design Finding
Wen et al., Drug Metab Dispos 2008 Single 600 mg dose of standardized extract, 3 healthy volunteers Half-lives of 1–3 h (free) and 3–8 h (conjugated). Conjugate exposure (AUC) was 4–30 times higher than free compound. Near peak (1–3 h), plasma silymarin was ≈17% free, 28% sulfated and 55% glucuronidated.
Hawke et al., J Clin Pharmacol 2010 140, 280, 560 or 700 mg every 8 h for 7 days, 32 patients with hepatitis C A 5-fold increase in dose raised steady-state exposure of silybin A 11-fold and silybin B 38-fold, showing nonlinear kinetics. Doses up to 2.1 g/day were well tolerated.
Barzaghi et al., Eur J Drug Metab Pharmacokinet 1990 Silybin–phosphatidylcholine complex (IdB 1016) vs silymarin, each equal to 360 mg silybin, 9 healthy volunteers Plasma silybin levels were higher at all time points with the complex. Terminal half-life was generally under 4 h. Under 3% of the dose was recovered in urine; much is likely excreted in bile.

Two practical points follow. First, because plasma levels rise more than proportionally with dose, the SyNCH investigators tested “higher than customary” doses (420 mg and 700 mg three times daily) in their later trials (Hawke et al., J Clin Pharmacol 2010). Second, the phosphatidylcholine complexes (often sold as “phytosome” products) were developed to raise absorption, and one such product was used in an Italian fatty liver trial (Loguercio et al., Free Radic Biol Med 2012).

Regulatory status

  • United States. Milk thistle is marketed as a dietary supplement. Supplements are not approved by the FDA before they are sold (NCCIH). The SyNCH hepatitis C trial was run under an FDA investigational new drug (IND) application (Fried et al., JAMA 2012).
  • Europe and Asia (oral). The investigators of the SyNCH trial describe Legalon 140, the standardized silymarin they used, as approved as a prescription drug for liver disorders in several countries of Europe and Asia (Fried et al., JAMA 2012).
  • Europe (IV). A 2012 review written by the manufacturer’s research staff stated that Legalon SIL was registered or licensed in more than a dozen European countries specifically for Amanita phalloides poisoning (Mengs et al., Curr Pharm Biotechnol 2012).
  • United States (IV). IV silibinin is not FDA-approved. It has been supplied through emergency IND requests (Mengs et al., Curr Pharm Biotechnol 2012) and in an open-label phase 2 US trial (NCT00915681) described below (ClinicalTrials.gov).
  • Sport. Milk thistle, silymarin and silibinin are not named on the WADA 2026 Prohibited List.

What the research shows

The US National Center for Complementary and Integrative Health (NCCIH) summarizes that trials of milk thistle in alcohol-related liver disease, hepatitis B and C, fatty liver disease and chemotherapy- or toxin-related liver problems “have been conflicting or too limited” to support conclusions (NCCIH). The trials behind that conclusion are below.

Alcoholic and viral liver disease: the Cochrane review

A 2007 Cochrane review pooled 18 randomized trials with 1,088 patients who had alcoholic liver disease and/or hepatitis B or C (Rambaldi et al., Cochrane 2007). Methodological quality was low: only 28.6% of trials reported high-quality characteristics.

Outcome (milk thistle vs placebo or no treatment) Relative risk (95% CI)
All-cause mortality 0.78 (0.53–1.15), not significant
Complications of liver disease 0.95 (0.83–1.09), not significant
Liver-related mortality, all trials 0.50 (0.29–0.88), significant
Liver-related mortality, high-quality trials only 0.57 (0.28–1.19), not significant
Adverse events 0.83 (0.46–1.50), not significant

There was also no significant effect on liver histology. The authors concluded that the results “question the beneficial effects” of milk thistle and that high-quality evidence was lacking.

Two of the larger individual trials in cirrhosis point in opposite directions:

Trial Patients Dose and duration Result
Ferenci et al., J Hepatol 1989 170 with cirrhosis (91 alcoholic) 140 mg silymarin three times daily; mean follow-up 41 months 4-year survival 58% vs 39% with placebo (p = 0.036); benefit seen in alcoholic cirrhosis and Child A patients in subgroup analyses
Parés et al., J Hepatol 1998 200 alcoholics with cirrhosis 150 mg silymarin three times daily; 2 years 15 deaths on silymarin vs 14 on placebo; no effect on survival or disease course

Hepatitis C: SyNCH and HALT-C

The SyNCH trial (Silymarin in NASH and C Hepatitis) was a double-blind, placebo-controlled NIH-funded trial at 4 US centers (Fried et al., JAMA 2012). It enrolled 154 people with chronic hepatitis C who had failed interferon-based treatment and had ALT (alanine aminotransferase, a liver enzyme) of 65 U/L or more. They took 420 mg or 700 mg of silymarin, or placebo, three times daily for 24 weeks.

Outcome at 24 weeks Placebo Silymarin 420 mg TID Silymarin 700 mg TID
Met primary ALT endpoint 3.8% (2 patients) 4.0% (2 patients) 3.8% (2 patients)
Mean ALT change, U/L (95% CI) −4.3 (−17.3 to 8.7) −14.4 (−41.6 to 12.7) −11.3 (−27.9 to 5.4)
Mean HCV RNA change, log10 IU/mL 0.07 −0.03 0.04

None of the differences was significant (primary endpoint p ≥ 0.99; ALT p = 0.75; HCV RNA p = 0.54), and quality of life did not differ. The authors concluded that higher-than-customary doses did not lower ALT more than placebo.

The HALT-C finding comes from a different kind of study. HALT-C was a trial of long-term peginterferon, not of silymarin. Researchers later analyzed 1,049 participants with advanced fibrosis or cirrhosis, 34% of whom reported having used silymarin at baseline (Freedman et al., Aliment Pharmacol Ther 2011). Users had less progression on liver biopsy (HR 0.57, 95% CI 0.33–1.00), but there was no effect on clinical outcomes over up to 8.65 years of follow-up. Because people chose whether to take silymarin, this is observational evidence and cannot show cause and effect. Users also differed from non-users at baseline (for example, more were men and they had higher ALT and albumin).

Fatty liver disease (NAFLD/NASH)

Results in nonalcoholic fatty liver disease (NAFLD) and its inflammatory form, steatohepatitis (NASH), are mixed. The two biopsy-based trials of plain silymarin both missed their primary endpoints:

Trial Patients Dose and duration Primary endpoint Other findings
Wah Kheong et al., Clin Gastroenterol Hepatol 2017 99 with biopsy-proven NASH, Malaysia 700 mg three times daily, 48 weeks ≥30% fall in NAFLD activity score: 32.7% vs 26.0% placebo (p = 0.467) Fibrosis improved by ≥1 stage in 22.4% vs 6.0% (p = 0.023); liver stiffness fell ≥30% in 24.2% vs 2.3% (p = 0.002)
Navarro et al., PLoS One 2019 (SyNCH NASH) 78 non-cirrhotic NASH, US 420 mg or 700 mg three times daily vs placebo, 48 weeks ≥2-point improvement in NAFLD activity score: 15% (700 mg), 19% (420 mg), 12% (placebo); p = 0.79 Central review found 63% did not meet histological entry criteria; fibrosis improved most in the placebo group (not significant)

The Malaysian authors wrote that a fibrosis benefit “remains to be confirmed in a larger trial.”

An Italian phase 3 trial tested Realsil, a silybin–phosphatidylcholine complex combined with vitamin E, twice daily for 12 months in 179 patients with biopsy-documented NAFLD (Loguercio et al., Free Radic Biol Med 2012). Forty-one patients withdrew, and 138 (69 per group) were analyzed per protocol. The treated group, but not the placebo group, improved in liver enzymes, insulin resistance (HOMA) and liver histology. Because vitamin E was part of the product, the effect of silybin alone cannot be separated.

A 2024 meta-analysis pooled 26 randomized trials with 2,375 patients (Li et al., Ann Hepatol 2024). It reported lower ALT, AST and blood lipids with silymarin and better steatosis on histology (OR 3.25, 95% CI 1.80–5.87). Its authors stated that the effects still need confirmation, and most included trials were smaller than the two biopsy trials above.

Drug-induced liver injury

Human data exist for two settings, neither of which involves anabolic steroids:

  • Tuberculosis drugs. A meta-analysis of 5 randomized trials (1,198 patients) found that silymarin given with anti-tuberculosis drugs reduced drug-induced liver injury at week 4 (RR 0.33, 95% CI 0.15–0.75), with adverse events similar to placebo (OR 1.09, 95% CI 0.86–1.39) (Tao et al., Can J Gastroenterol Hepatol 2019).
  • Childhood leukemia chemotherapy. In a double-blind pilot trial, 50 children with acute lymphoblastic leukemia and liver toxicity received milk thistle or placebo for 28 days (Ladas et al., Cancer 2010). There were no significant changes in ALT, AST or bilirubin at day 28. At day 56, AST was lower in the milk thistle group (p = 0.05), with a trend for ALT (p = 0.07).

Anabolic steroids: no human evidence

Claim vs evidence. Milk thistle is widely promoted as liver protection for people taking oral steroids. No controlled human study has tested this. Its use for this purpose rests on extrapolation, not data.

The only direct data are from animals:

  • In a rat study, rats given oral methandienone (2 mg/kg/day) with forced swimming for 8 weeks were compared with rats given the same plus silymarin (20 mg/kg/day). The silymarin group had differences on liver tissue staining that the authors interpreted as protective (Radovanović et al., Med Pregl 2003). No liver enzymes or clinical outcomes in people were measured.
  • A 2023 rat study of nandrolone decanoate looked at heart and skeletal muscle, not the liver (Hassan et al., BMC Pharmacol Toxicol 2023).

Animal findings like these do not show that milk thistle prevents liver injury from steroids such as oxandrolone (Anavar) in people. The bile acids TUDCA and ursodiol (UDCA), also marketed for this purpose, have their own pages with their own (also limited) evidence.

Intravenous silibinin for Amanita (death-cap) poisoning

Amatoxins, found in Amanita phalloides and related mushrooms, damage the liver and kidneys by irreversibly binding RNA polymerase II, an enzyme cells need to make proteins (Enjalbert et al., J Toxicol Clin Toxicol 2002). IV silibinin is proposed to block the uptake of amatoxin into liver cells through hepatic transport proteins, interrupting recirculation of the toxin (Mengs et al., Curr Pharm Biotechnol 2012).

The product and dose

Legalon SIL is a freeze-dried powder for infusion. Each vial contains 528.5 mg of silibinin-C-2’,3-dihydrogen succinate, disodium salt, equal to 350 mg silibinin by one assay or 315 mg by HPLC. The dose given in the manufacturer review and the US trial protocol is a 5 mg/kg loading dose followed by 20 mg/kg/day by continuous infusion (Mengs et al., Curr Pharm Biotechnol 2012; ClinicalTrials.gov).

What the evidence shows

There are no randomized controlled trials. The evidence comes from case series and retrospective reviews:

Source Data Finding
Enjalbert et al., J Toxicol Clin Toxicol 2002 2,108 hospitalized cases from North America and Europe over 20 years Silybin (alone or in combination) and NAC alone were associated with the best survival; penicillin showed little efficacy; no benefit for thioctic acid or steroids
Mengs et al., Curr Pharm Biotechnol 2012 (manufacturer authors) Nearly 1,500 documented cases Mortality under 10% with Legalon SIL vs over 20% with penicillin or penicillin plus silibinin
Tan et al., Clin Toxicol 2022 877 published cases over 40 years Survival 59% with supportive care only vs 90% with silibinin (OR 6.40, 95% CI 3.14–13.04); no statistically significant difference in cases with amanitin proven in the lab
De Olano et al., Clin Toxicol 2021 148 suspected cases in the US National Poison Data System, 2008–2018 Overall mortality 8.8%; 9.5% (4/42) in silibinin/silymarin-treated vs 8.5% (9/106) in untreated cases

The US data are an important check. The “over 20%” untreated mortality often cited for comparison comes from older case series. De Olano and colleagues found a contemporary US mortality of 8.8% and suggested it reflects better supportive care. They proposed it as the benchmark for future comparisons.

The open-label phase 2 US trial of Legalon SIL (NCT00915681) started in 2009, screened 148 people and treated 102. It was terminated in 2020 by sponsor decision, and the posted results state that no primary analysis was performed because data were unavailable for most patients (ClinicalTrials.gov). NAC is also used in amatoxin poisoning; see the NAC page.

Side effects and risks

Tolerability

Oral milk thistle is generally well tolerated. In the Cochrane review, adverse events were not more common than with placebo (RR 0.83, 95% CI 0.46–1.50) (Rambaldi et al., Cochrane 2007). In the SyNCH hepatitis C trial at up to 2.1 g/day, the adverse event profile was similar to placebo. Gastrointestinal symptoms were the most frequent, in 12% of people on silymarin vs 5% on placebo (Fried et al., JAMA 2012). NCCIH lists bloating, nausea and gas as the most common side effects (NCCIH).

Allergy

Milk thistle may cause allergic reactions, especially in people allergic to related plants such as ragweed, chrysanthemum, marigold and daisy (NCCIH).

Pregnancy and breastfeeding

Little is known about safety in pregnancy or breastfeeding (NCCIH). A safety review notes that one clinical trial reported no anomalies in pregnancy but advises caution and more human study (Soleimani et al., Phytother Res 2019).

Drug interactions

Laboratory studies suggested milk thistle components might inhibit drug-metabolizing enzymes, but human studies have mostly not confirmed this:

Study Design Finding
Kawaguchi-Suzuki et al., Drug Metab Dispos 2014 9 healthy volunteers, standardized extract three times daily for 14 days, four probe drugs No significant effect on CYP1A2, CYP2C9, CYP2D6 or CYP3A4/5
Han et al., Eur J Clin Pharmacol 2009 12 healthy men, 140 mg silymarin three times daily for 14 days, then losartan Losartan exposure rose in people with the common CYP2C9*1/*1 genotype, and its active metabolite fell in both genotypes tested

A 2019 safety review concluded that silymarin has few drug interactions and no major effects on cytochrome P450 enzymes, but advised caution with drugs that have a narrow therapeutic window (a small gap between effective and toxic doses) (Soleimani et al., Phytother Res 2019). NCCIH advises people who take any medicine to talk with their health care provider before using milk thistle (NCCIH).

Quality and contamination

Supplement products vary widely. A study of 26 milk thistle supplements bought in the US and Czech Republic in 2016–2017 found large differences in silymarin content, often not matching the label, and substantial differences between batches of the same product (Fenclova et al., Sci Rep 2019). All products tested contained mycotoxins (toxins made by molds), and the authors also found pesticide residues and microbial contamination. They suggested that this variability may help explain inconsistent trial results and could itself contribute to supplement-related liver injury. NCCIH also notes reports of products with silymarin amounts different from the label and contamination with pesticides, microorganisms or mycotoxins (NCCIH).

Key takeaways

  • A plant extract, not a single drug. Silymarin is a mix of flavonolignans led by silybin; it is poorly absorbed, rapidly conjugated and has a short half-life of a few hours.
  • Liver trials are mostly negative. The Cochrane review found no effect on mortality or complications, and the US SyNCH trials in hepatitis C and NASH missed their primary endpoints even at 2.1 g/day.
  • Some signals, not proof. Fibrosis improved in one Malaysian NASH trial, and a meta-analysis found less tuberculosis drug-induced liver injury, but these findings need confirmation.
  • No evidence for steroid users. No human study has tested milk thistle for liver protection with anabolic steroids; the only data are from rats.
  • IV silibinin is a niche antidote. A 2012 manufacturer review reported it licensed in over a dozen European countries for death-cap poisoning, but the evidence is uncontrolled and recent US data show similar mortality with and without it.
  • Generally well tolerated, but product quality varies. Mild gut symptoms are most common; allergy is possible in people sensitive to daisy-family plants, and tested products often missed label claims or contained mycotoxins.

Sources

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  28. World Anti-Doping Agency. The 2026 Prohibited List. WADA 2026 Prohibited List.