milk thistle

Complementary/Alternative Medicine: This monograph describes a natural or herbal product that is not subject to FDA guidelines for medicines. Patients and clinicians are advised to read package labels carefully to ensure safe and efficacious use.

REMS

Cirrhosis, chronic hepatitis, gallstones, psoriasis, liver cleansing and detoxification, treatment of liver toxicity due to Amanita mushroom poisoning (European IV formulation), and chemicals
Dyspepsia (in combination with other herbs)
Diabetes

Action ⬆ ⬇

The active component, silymarin, has antioxidant and hepatoprotectant actions. Silymarin helps prevent toxin penetration and stimulates hepatocyte regeneration.

Therapeutic effects:

Liver detoxification.
Improved dyspepsia symptoms.
Decreased fasting blood glucose.

Pharmacokinetics ⬆ ⬇

Absorption: 23–47% absorbed after oral administration.

Distribution: Unknown.

Metabolism/Excretion: Hepatic metabolism by cytochrome P450 3A4.

Half-Life: 6 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO	5–30 days or more	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Pregnancy and lactation (insufficient information available);
Allergy to chamomile, ragweed, asters, chrysanthemums, and other members of the family Asteraceae/Compositae.

Use Cautiously in:

Hormone-sensitive cancers/conditions (milk thistle plant parts may have estrogenic effects).

Adv. Reactions/Side Effects ⬆ ⬇

GI: anorexia, bloating, Laxative effect, nausea

Misc: Allergic reactions

Interactions ⬆ ⬇

Natural-Drug Products:

In vitro, milk thistle extract inhibited the drug-metabolizing enzyme cytochrome P450 3A4. Interactions have not been reported in humans, but milk thistle should be used cautiously with other drugs metabolized by 3A4, such as cyclosporine, carbamazepine, HMG-CoA inhibitors, ketoconazole, and alprazolam.

Natural-Natural Products:

Herbs with hypoglycemic potential may have additive hypoglycemic effects.

Route/Dosage ⬆ ⬇

PO (Adults ): Hepatic cirrhosis: 420 mg/day of extract containing 70–80% silymarin; Chronic active hepatitis: 140 mg tid of silymarin; 240 mg bid of silibinin; Diabetes: 200 mg tid of silymarin; Tea: 3–4 times daily 30 min before meals. Tea is not recommended as silymarin is not sufficiently water soluble.
IV (Adults ): 20–50 mg/kg over 24 hr, 48 hr post–mushroom ingestion (IV formulation not available in US).

Availability ⬆ ⬇

Capsules: ^OTC
Tablets: ^OTC
Crude drug: ^OTC
Tea: ^OTC
Extract: ^OTC

Assessment ⬆ ⬇

Assess patients for signs of liver failure (jaundice, mental status changes, abdominal distention, ascites, generalized edema).
Evaluate consistency and frequency of bowel movements.

Lab Test Considerations:

Monitor liver function, lipid profile, and blood glucose periodically during therapy.

Implementation ⬆ ⬇

PO: Orally as an extract, capsule, tablets, or as a dried fruit as a single daily dose or divided into three doses.
Tea is not recommended as milk thistle is not water-soluble.

Patient/Family Teaching ⬆ ⬇

Inform patient of symptoms of liver failure; advise patient to report worsening symptomatology promptly to health care professional.
Advise patients to avoid alcohol and follow diet for liver or gall bladder disease being treated.
Emphasize the need for blood tests to monitor liver function tests.

Evaluation/Desired Outcomes ⬆ ⬇

Normalization of liver function tests.
Reduction in jaundice, abdominal distention, fatigue, and other symptoms associated with liver disease.

US Brand Names ⬆ ⬇

Holy thistle, Lady's thistle, Mary Thistle, Silybin, Silymarin

Code ⬆

NDC Code

0220- Boiron
- 0220-1191- Carduus Marianus
  - 0220-1191-41- 6 [hp_X] in 1 TUBE (0220-1191-41)

0220- Boiron
- 0220-1192- Carduus marianus
  - 0220-1192-41- 6 [hp_C] in 1 TUBE (0220-1192-41)

0220- Boiron
- 0220-1193- Carduus marianus
  - 0220-1193-41- 30 [hp_C] in 1 TUBE (0220-1193-41)

13838- Phytodyne Inc.
- 13838-1422- Carduus marianus
  - 13838-1422-1- 20 mL in 1 BOTTLE, GLASS (13838-1422-1)

62106- Seroyal USA
- 62106-7587- CARDUUS MARIANUS
  - 62106-7587-4- 10 TUBE in 1 CARTON (62106-7587-4) > 140 GRANULE in 1 TUBE

71919- Washington Homeopathic Products
- 71919-166- Carduus marianus
  - 71919-166-07- 15 mL in 1 VIAL, GLASS (71919-166-07)

71919- Washington Homeopathic Products
- 71919-166- Carduus marianus
  - 71919-166-08- 30 mL in 1 VIAL, GLASS (71919-166-08)

71919- Washington Homeopathic Products
- 71919-166- Carduus marianus
  - 71919-166-09- 50 mL in 1 BOTTLE, GLASS (71919-166-09)

71919- Washington Homeopathic Products
- 71919-166- Carduus marianus
  - 71919-166-10- 100 mL in 1 BOTTLE, GLASS (71919-166-10)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇