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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ECHINACEA, UNSPECIFIED: 10 Adverse Event Reports & Safety Profile

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10
Total FAERS Reports
1 (10.0%)
Deaths Reported
5
Hospitalizations
10
As Primary/Secondary Suspect
Uriel Pharmacy Inc.
Manufacturer

Route: ORAL · Manufacturer: Uriel Pharmacy Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20180208 · Latest Report: 20220521

What Are the Most Common ECHINACEA, UNSPECIFIED Side Effects?

#1 Most Reported
Nausea
3 reports (30.0%)
#2 Most Reported
Malaise
3 reports (30.0%)
#3 Most Reported
Fatigue
3 reports (30.0%)

All ECHINACEA, UNSPECIFIED Side Effects by Frequency

No side effect data available.

Who Reports ECHINACEA, UNSPECIFIED Side Effects? Age & Gender Data

Gender: 88.9% female, 11.1% male. Average age: 61.0 years. Most reports from: US. View detailed demographics →

Is ECHINACEA, UNSPECIFIED Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 3 0 3
2022 1 0 0

View full timeline →

Official FDA Label for ECHINACEA, UNSPECIFIED

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses Temporarily relieves discomfort associated with allergic skin reactions and non-allergic skin irritations, including occasional itching, swelling, and eruption of welts.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE. NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage & Administration

Directions Take 30 drops orally twice daily or as directed by a healthcare professional. Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

Warnings

Warnings Do not use if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days rash develops If pregnant or breast feeding, consult a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredients Echinacea 3X HPUS* Ferrum phosphoricum 6X HPUS* Kali muriaticum 6X HPUS* Zincum gluconicum 2X HPUS* * The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Inactive Ingredients

Inactive ingredients Gelatin, Lactose USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP