Adverse Event Profile: Milk Thistle

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 17 Serious Events: 7 Date Range: 20100920 to 20250909

Top Reported Reactions

  • Diarrhoea: 3
  • JAUNDICE: 2
  • PRURITUS: 2
  • HYPERSENSITIVITY: 2
  • BLOOD CHOLESTEROL INCREASED: 2
  • HEPATIC ENZYME INCREASED: 2
  • ALOPECIA: 2
  • Abdominal pain: 1
  • Drug-induced liver injury: 1
  • Haemangioma of liver: 1
  • Hepatitis cholestatic: 1
  • Hepatomegaly: 1
  • Hospitalisation: 1
  • Jaundice: 1
  • Nausea: 1
  • Vomiting: 1
  • ABDOMINAL PAIN: 1
  • ANOREXIA: 1
  • BODY TEMPERATURE INCREASED: 1
  • CHROMATURIA: 1

Outcomes

  • Other Serious or Important Medical Event: 12
  • Visited Emergency Room: 6
  • Visited a Health Care Provider: 6
  • Hospitalization: 4
  • Disability: 2
  • Other Outcome: 1
  • Life Threatening: 1
  • Other Serious Outcome: 1

Products Involved (7 unique)

  • MILK THISTLE
  • MILK THISTLE DIETARY SUPPLEMENT
  • OREGON WILD HARVEST MILK THISTLE
  • PURITANS PRIDE MILK THISTLE PRODUCT
  • Pure Synergy Super Pure Milk Thistle
  • SILYBUM MARIANUM
  • SUPER MILK THISTLE

Disclaimer

This data is from the FDA CAERS database. A report does not mean the supplement caused the adverse event. Reports may be incomplete, duplicated, or unrelated. This is for safety awareness only.