Author: Dr. Christopher J. Etheridge. British Herbal Medicine Association (BHMA) Chair
Background
Echinacea preparations are widely used for the prevention and treatment of respiratory tract infections (RTIs), yet current monographs differ on duration of use and on use in children. The HMPC limits continuous use to 10 days and does not recommend use under 12 years of age, whereas the ESCOP monographs accept preventive use for up to 2 months and support use across all age groups. A new systematic review and meta-analysis in Planta Medica re-examines the safety of oral Echinacea within a risk-benefit framework.
Methods
Controlled clinical trials of oral Echinacea (all species and preparations) against placebo, active treatment or no treatment were included if they reported safety data. Adverse events (AEs) were classified by System Organ Class and compared with 1010 spontaneous reports from EudraVigilance (EVDAS).
Main results
Forty-eight controlled trials (10115 participants) reported 2396 AEs. Nineteen trials were preventive (up to 6 months) and 29 were therapeutic.
• Overall: AEs occurred in 22.7% of participants with Echinacea and 24.8% with control (p = 0.014). The pooled risk ratio for experiencing at least one AE was not significant (RR 0.98, 95% CI 0.95 to 1.01; random effects model RR 1.03, 95% CI 0.88 to 1.21).
• Prevention and children: no difference from control in preventive trials (21.3% versus 22.3%, p = 0.411) or in trials in children (25.7% versus 23.8%, p = 0.314).
• Acute treatment: fewer AEs with Echinacea when pressed juice preparations were excluded (19.8% versus 25.1%, p < 0.0001). With pressed juice, AEs were more frequent than with control (37.8% versus 31.9%, p = 0.026).
• Type of AE: mainly nervous system disorders such as headache (13.1% versus 12.0%) and gastrointestinal disorders (11.3% versus 10.7%).
• Serious AEs: five with Echinacea (0.09%) and four with control (0.08%); no deaths.
• EVDAS: reports were mainly gastrointestinal (17.7%) and skin disorders (16.1%). Ten reports involved anaphylaxis, four of them with intravenous products no longer in use. No fatal reaction to oral Echinacea was identified.
Conclusion
The authors conclude that oral Echinacea preparations have a high level of safety, with differences between types of preparation. Preventive use for up to 6 months and use in children aged 1 to 12 years were not associated with more AEs than control, which is consistent with the position of the ESCOP monographs. Caution in patients with known allergy to Asteraceae may still be appropriate.
The authors suggest that the lower AE rate with ethanolic extracts in acute treatment may reflect efficacy; this remains a hypothesis. Methods of recording AEs varied between trials, AEs could not be distinguished from adverse drug reactions, and under-reporting in pharmacovigilance data is likely.
Reference: Ogal M, Willcox M, Bauer R, Johnston SL, Kreft S, Booker A, Schapowal A, Roux D, Gancitano G, Stange R. Safety of Oral Echinacea Preparations: Systematic Review and Meta-Analysis in the Context of Therapeutic Benefit. Planta Med 2026 (accepted manuscript, online 28 October 2026). DOI: 10.1055/a-2992-1199. Accessed 12 November 2026.
More information about Echinacea (ESCOP monographs):
• Echinaceae purpureae herba (Purple Coneflower Herb), 2021
• Echinaceae purpureae radix (Purple Coneflower Root), 2021
• Echinaceae angustifoliae radix (Narrow-leaved Coneflower Root), 2019
• Echinaceae pallidae radix (Pale Coneflower Root), 2018