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Phytother Res. 2019 May 8. doi: 10.1002/ptr.6361. [Epub ahead of print]

Safety and toxicity of silymarin, the major constituent of milk thistle extract: An updated review.

Author information

1
School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
2
Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
3
Department of Pharmacology and Toxicology, Faculty of Pharmacy, University of Ahl Al Bayt, Karbala, Iraq.
4
Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University ofMedical Sciences, Mashhad, Iran.
5
Department of Pharmacology and Toxicology, Faculty of Pharmacy, Alzahraa University, Karbala, Iraq.
6
Pharmaceutical Research Center, Institute of Pharmaceutical Technology, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Milk thistle (Silybum marianum) is a medicinal plant from the Asteraceae family. Silymarin is the major constituent of milk thistle extract and is a mixture of some flavonolignans such as silybin, which is the most active component of silymarin. It is most commonly known for its hepatoprotective effect. Also, studies have shown other therapeutic effects such as anticancer, anti-Alzheimer, anti-Parkinson, and anti-diabetic, so its safety is very important. It has no major toxicity in animals. Silymarin was mutagen in Salmonella typhimurium strains in the presence of metabolic enzymes. Silybin, silydianin, and silychristin were not cytotoxic and genotoxic at concentration of 100 μM. Silymarin is safe in humans at therapeutic doses and is well tolerated even at a high dose of 700 mg three times a day for 24 weeks. Some gastrointestinal discomforts occurred like nausea and diarrhea. One clinical trial showed silymarin is safe in pregnancy, and there were no anomalies. Consequently, caution should be exercised during pregnancy, and more studies are needed especially in humans. Silymarin has low-drug interactions, and it does not have major effects on cytochromes P-450. Some studies demonstrated that the use of silymarin must be with caution when co-administered with narrow therapeutic window drugs.

KEYWORDS:

Silybum marianum; Silymarin; adverse reactions; safety; toxicity

PMID:
31069872
DOI:
10.1002/ptr.6361

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