European Union regulation of elderberry summary
European Union regulation of elderberry summary

By Nnenna Udensi, MD

APPENDIX A

Summary of European Medicines Agency Assessment Report on Sambucus nigra. (Elderberry)

Non-Clinical Data
Elderberry Activities Findings
Immunological Activity
  • May modulate activity of immune cells.
  • Data is not conclusive.
Antiviral Activity
  • Inhibitory effect on influenza virus strains studied.
  • Clear results in lab studies
  • Mixed results in studies on human cells*.
Antioxidative activity
  • High concentrations of chemicals known for antioxidant properties.
  • Mixed study results on effects of stress in cells* in vitro.
  • Applications Unclear
Antibacterial activity
  • Antibacterial activity found against H. Pylori and MRSA.
Lectin Activities
  • Lectins are sugar binding proteins
  • Lectin activities have been established by studies
  • Applications for lectin activities (diabetes) has been studied. Mixed results.
Toxicology
  • High-risk of toxicity with ripe fruit
  • No concerns with cooked or heat treated products.
  • Avoid bark of the plant. (toxic)
Clinical Data
Low Bioavailability
  • The proportion of active substances in elderberry that enter the circulation after being consumed is low across all preparations.
Dose response
  • Little data is available for dosing, likely due to low bioavailability.
Safety Data
Adverse Events
  • Adverse events in a few individuals have been reported.
  • Abdominal pain, Edema in Legs, Decreased INR (increased blood clotting)

*For the purposes of this report, Non clinical data represents pharmacodynamics, and toxicology from laboratory (in-vitro) experiments. Clinical data represents pharmacokinetic, bioavailability, and clinical trial data. Safety data represents information on clinical exposures.