Evigrade

Silymarin (Silybum marianum)

AEMPS

Plant antioxidant from milk thistle fruits; IV silibinin is an antidote in Amanita phalloides poisoning

ATC code: A05BA03

Brand names: Legalon SIL, Milk thistle (various), Siliphos

Updated · Methodology

Indications

B

Amatoxin (death cap) mushroom poisoning

First line

Intravenous silibinin (Legalon SIL) is part of the standard protocol for confirmed Amanita phalloides poisoning. Dose: 5 mg/kg over 1 hour, then 20 mg/kg/day continuous infusion for 3–5 days. The drug blocks α-amanitin uptake by hepatocytes and reduces mortality. SEIMC 2022 and Spanish toxicology centres recommend «IV silibinin + NAC + supportive care + early contact with a transplant centre». Oral milk thistle capsules do not work in acute poisoning – the IV formulation in hospital is required.

ICD-10: T62.0 · ICD-11: NE61

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Alcoholic liver disease

Not recommended

Cochrane 2017 reviewed 18 randomised trials in 1088 patients with alcoholic or viral liver disease: milk thistle did not reduce all-cause mortality, cirrhosis complications or improve liver histology. and do not recommend silymarin for alcoholic liver disease. The evidence-based intervention is full alcohol abstinence; in severe hepatitis, systemic glucocorticoids by the Maddrey score apply. Alcohol dependence is best addressed through programmes (psychotherapy, naltrexone, acamprosate), not a milk thistle course.

ICD-10: K70 · ICD-11: DB94

D

Body detoxification and cleansing

Not recommended

Silymarin is the active compound of milk thistle extract. It is widely marketed for "detox" and "cleansing" the body. Studies have not shown convincing benefit for this use: the idea of "toxins" that a supplement clears out has no evidence base, and the liver and kidneys clear metabolites on their own. Silymarin is harmless in this role, but there is no benefit to expect from it. When there is a real problem with the liver or another organ, what helps is testing and treating the cause, not "cleansing." This product does not replace therapy with proven benefit, so taking it instead of prescribed treatment is risky because of the time lost.

D

Chronic hepatitis C

Not recommended

Silymarin is an extract of milk thistle, promoted to protect the liver, including in chronic hepatitis C. Studies have not shown convincing benefit for this use: silymarin does not meaningfully change the course of the infection or the state of the liver, and there is no evidence base supporting it here. Chronic hepatitis C responds to direct-acting antiviral treatment, which cures most patients. Silymarin is harmless in this role, but taking it instead of treatment with proven benefit risks missing the care that actually works. A doctor chooses the regimen

ICD-10: B18.2 · ICD-11: 1E51.1

D

Hangover recovery

Not recommended

Silymarin is an extract of milk thistle, promoted for liver support and recovery after drinking alcohol. The evidence does not show a clear benefit for this use – there is no solid data confirming faster recovery after alcohol. What actually helps is time, water and sleep, and medical care if you feel seriously unwell. The substance itself is harmless here, but you should not expect it to speed up recovery from alcohol.

ICD-11: MG49

D

Non-alcoholic fatty liver disease

Not recommended

Milk thistle is often advised for «fatty liver» on ultrasound. Meta-analyses show weak and inconsistent effects on ALT and AST (5–10 IU/L reduction) and no change in steatosis grade on imaging. 2024 and 2023 do not mention silymarin in MASLD/NAFLD management standards. Evidence-based options are 7–10% weight loss, Mediterranean diet, glucose and lipid control, and in confirmed MASH resmetirom or semaglutide as prescribed. Concerns about a fatty liver ultrasound finding require full assessment by a gastroenterologist, not a supplement course.

ICD-10: K76.0 · ICD-11: DB92

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Mixture of milk thistle flavonolignans: silibinin A and B (50–60% of the active fraction), silicristin, silidianin and isosilicristin. Binds OATP1B1 and OATP1B3 transporters in hepatocytes, competes with α-amanitin uptake and prevents toxin entry. Additionally inhibits NF-κB, reduces lipid peroxidation and stimulates protein synthesis via RNA polymerase I. Oral bioavailability is low (about 1%); intravenous silibinin (Legalon SIL) bypasses this barrier.

Safety

Contraindications

  • Hypersensitivity to milk thistle or other Asteraceae family members (ragweed, chrysanthemum)
  • Oestrogen-dependent tumours (theoretical phytoestrogenic activity)
  • Age under 12 years

Serious adverse effects

  • Anaphylactic reactions in patients allergic to Asteraceae family
  • Single reports of hepatotoxicity at megadoses
  • Potentiation of hypoglycaemic drugs (glucose monitoring needed in diabetes)

Common adverse effects

  • Nausea
  • Diarrhoea and laxative effect
  • Bloating
  • Allergic rash

Pregnancy: can you take Silymarin (Silybum marianum)?

AEMPS summary of product characteristics (section 4.6): animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. Because there are no studies in pregnant women and animal reproductive studies do not always predict the human response, silymarin should not be used during pregnancy unless the woman's clinical condition requires it.

Breastfeeding: can you take Silymarin (Silybum marianum)?

Use with caution. Hale L3. Limited data; small amounts pass into milk. eLactancia rates risk as low for short courses. Long-term supplement use during lactation is not justified.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Karsil and milk thistle are massively sold in Russian pharmacies as both medicines and supplements. They are prescribed for any ALT/AST elevation, steatosis, hepatitis, or post-binge recovery. In real gastroenterology, liver screening requires identifying the cause: alcohol, hepatitis B/C, metabolic syndrome, drugs. Taking silymarin 'just in case' does not replace diagnostics or protect the liver.

Common myths

Myth: 'After holidays take Karsil to restore the liver'. Fact: the liver is a regenerating organ that recovers on its own once the damaging factor is removed. You can help the liver only by eliminating the cause of damage: alcohol cessation, weight loss, stopping a hepatotoxic drug. Silymarin adds nothing to this process.

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Frequently asked

What is Silymarin (Silybum marianum) used for?

Silymarin (Silybum marianum) is evaluated for the following indications with varying evidence strength: Amatoxin (death cap) mushroom poisoning (evidence tier B), Alcoholic liver disease (evidence tier D), Chronic hepatitis C (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Silymarin (Silybum marianum)?

Common side effects of Silymarin (Silybum marianum) (≥ 1 in 100): Nausea, Diarrhoea and laxative effect, Bloating, Allergic rash. See the Safety section for uncommon and serious reactions.

Is Silymarin (Silybum marianum) safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. Because there are no studies in pregnant women and animal reproductive studies do not always predict the human response, silymarin should not be used during pregnancy unless the woman's clinical condition requires it.

Is Silymarin (Silybum marianum) compatible with breastfeeding?

Use with caution. Hale L3. Limited data; small amounts pass into milk. eLactancia rates risk as low for short courses. Long-term supplement use during lactation is not justified.

Can you drink alcohol while taking Silymarin (Silybum marianum)?

In real gastroenterology, liver screening requires identifying the cause: alcohol, hepatitis B/C, metabolic syndrome, drugs. You can help the liver only by eliminating the cause of damage: alcohol cessation, weight loss, stopping a hepatotoxic drug.

Who should not take Silymarin (Silybum marianum)?

Silymarin (Silybum marianum) is contraindicated in: Hypersensitivity to milk thistle or other Asteraceae family members (ragweed, chrysanthemum); Oestrogen-dependent tumours (theoretical phytoestrogenic activity); Age under 12 years. Full list in the Safety section.

After holidays take Karsil to restore the liver

the liver is a regenerating organ that recovers on its own once the damaging factor is removed. You can help the liver only by eliminating the cause of damage: alcohol cessation, weight loss, stopping a hepatotoxic drug. Silymarin adds nothing to this process.

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