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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.

HAWTHORN LEAF WITH FLOWER: 30 Adverse Event Reports & Safety Profile

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30
Total FAERS Reports
1 (3.3%)
Deaths Reported
21
Hospitalizations
30
As Primary/Secondary Suspect
8
Life-Threatening
Boiron
Manufacturer

Route: ORAL · Manufacturer: Boiron · HUMAN PRESCRIPTION DRUG · FDA Label: Available

First Report: 20141224 · Latest Report: 20240202

What Are the Most Common HAWTHORN LEAF WITH FLOWER Side Effects?

#1 Most Reported
Eosinophilic cellulitis
10 reports (33.3%)
#2 Most Reported
Urinary retention
5 reports (16.7%)
#3 Most Reported
Somnolence
5 reports (16.7%)

All HAWTHORN LEAF WITH FLOWER Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Eosinophilic cellulitis 10 33.3% 0 10
Bradypnoea 5 16.7% 0 5
Long qt syndrome 5 16.7% 0 5
Somnolence 5 16.7% 0 5
Urinary retention 5 16.7% 0 5

Who Reports HAWTHORN LEAF WITH FLOWER Side Effects? Age & Gender Data

Gender: 75.0% female, 25.0% male. Average age: 70.0 years. Most reports from: FR. View detailed demographics →

Is HAWTHORN LEAF WITH FLOWER Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2017 2 0 2
2020 5 0 5
2021 3 0 0
2023 10 0 10
2024 1 0 0

View full timeline →

What Is HAWTHORN LEAF WITH FLOWER Used For?

IndicationReports
Product used for unknown indication 22

Official FDA Label for HAWTHORN LEAF WITH FLOWER

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of muscle cramps or spasms, mild abdominal or chest pain, or anxiousness.*

Dosage & Administration

DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS Seek medical attention immediately for severe symptoms such as chest pressure or tightness with radiation of the pain to the jaw and down the arm, shortness of breath, or sweating. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Active Ingredient

ACTIVE INGREDIENTS Crataegus oxyacantha 2X Cactus grandiflorus 3X Kali carbonicum 3X Spigelia anthelmia 3X Glonoinum 6X

Inactive Ingredients

Peony Root(10%), Citrus Peel(10%), Agastache(10%), Gardenia Fruit(5%), Turmeric(5%), Ginger(5%), Jujube(5%), Cabbage(5%), Fructooligosaccharides(5%)