ECHINACEA PURPUREA

25/100 · Low Risk

Manufactured by Boiron

Low Report Volume for Echinacea Purpurea Adverse Events

Last updated: 2026-05-12

About ECHINACEA PURPUREA

ECHINACEA PURPUREA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boiron. Based on analysis of FDA adverse event reports, ECHINACEA PURPUREA has a safety score of 25 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ECHINACEA PURPUREA.

AI Safety Analysis

Echinacea Purpurea has a safety concern score of 25 out of 100, placing it in the low concern category based on analysis of FDA adverse event data. The FDA has received approximately N/A adverse event reports for this medication, which is primarily manufactured by Boiron.

Of classified reports, 59.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. No serious adverse events reported.

All reported events are non-serious. The majority of reports are from adults aged 60 and above.

Patients taking Echinacea Purpurea should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 25/100

Echinacea Purpurea received a safety concern score of 25/100 (low concern). This is based on a 59.8% serious event ratio across 82 classified reports. The score accounts for N/A total adverse event reports and 0 distinct reaction types. This relatively low score suggests a favorable safety profile in reported data.

Key Safety Signals

  • No serious events reported.
  • All events are non-serious.
  • Low report volume limits data analysis.

Patient Demographics

The most frequently reported age groups are age 71 (6 reports), age 56 (3 reports), age 59 (3 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 82 classified reports for ECHINACEA PURPUREA:

  • Serious: 49 reports (59.8%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 33 reports (40.2%)
Serious 59.8%Non-Serious 40.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Age

Age 716 reports
Age 563 reports
Age 593 reports
Age 673 reports
Age 452 reports
Age 462 reports
Age 622 reports
Age 632 reports
Age 642 reports
Age 692 reports
Age 752 reports
Age 762 reports
Age 772 reports
Age 01 reports
Age 321 reports
Age 341 reports
Age 391 reports
Age 401 reports
Age 431 reports
Age 441 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

What You Should Know

If you are taking Echinacea Purpurea, here are important things to know. Monitor for any unusual symptoms when taking Echinacea Purpurea. Consult a healthcare provider if you experience any adverse effects. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

Given the low number of reports, the safety profile of Echinacea Purpurea remains inconclusive based on current data.

Frequently Asked Questions

How many adverse event reports has the FDA received for Echinacea Purpurea?

The FDA has received approximately N/A adverse event reports associated with Echinacea Purpurea. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What percentage of Echinacea Purpurea adverse event reports are serious?

Out of 82 classified reports, 49 (59.8%) were classified as serious and 33 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

What age groups report the most side effects for Echinacea Purpurea?

The most frequently reported age groups for Echinacea Purpurea adverse events are: age 71: 6 reports, age 56: 3 reports, age 59: 3 reports, age 67: 3 reports, age 45: 2 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Echinacea Purpurea?

The primary manufacturer associated with Echinacea Purpurea adverse event reports is Boiron. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

How do I report a side effect from Echinacea Purpurea?

You can report adverse events from Echinacea Purpurea to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Echinacea Purpurea's safety score and what does it mean?

Echinacea Purpurea has a safety concern score of 25 out of 100 (low concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. No serious adverse events reported.

What are the key safety signals for Echinacea Purpurea?

Key safety signals identified in Echinacea Purpurea's adverse event data include: No serious events reported.. All events are non-serious.. Low report volume limits data analysis.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

What should patients know before taking Echinacea Purpurea?

Monitor for any unusual symptoms when taking Echinacea Purpurea. Consult a healthcare provider if you experience any adverse effects.

Are Echinacea Purpurea side effects well-documented?

Echinacea Purpurea has N/A adverse event reports on file with the FDA. All reported events are non-serious. The volume of reports for Echinacea Purpurea reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Echinacea Purpurea?

Given the low number of reports, the safety profile of Echinacea Purpurea remains inconclusive based on current data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to ECHINACEA PURPUREA based on therapeutic use, drug class, or shared indications:

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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.