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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.

COUMARIN: 19 Adverse Event Reports & Safety Profile

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19
Total FAERS Reports
1 (5.3%)
Deaths Reported
12
Hospitalizations
19
As Primary/Secondary Suspect
8
Life-Threatening
Professional Complementary ...
Manufacturer

Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available

First Report: 2009 · Latest Report: 2009

What Are the Most Common COUMARIN Side Effects?

#1 Most Reported
Drug ineffective
8 reports (42.1%)
#2 Most Reported
Hyponatraemia
7 reports (36.8%)
#3 Most Reported
Renal impairment
6 reports (31.6%)

All COUMARIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 8 42.1% 0 8
Hyponatraemia 7 36.8% 0 7
Renal impairment 6 31.6% 0 6

Who Reports COUMARIN Side Effects? Age & Gender Data

Gender: 93.3% female, 6.7% male. Average age: 68.7 years. Most reports from: HU. View detailed demographics →

Is COUMARIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0

View full timeline →

What Is COUMARIN Used For?

IndicationReports
Product used for unknown indication 8

Official FDA Label for COUMARIN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of bloating, gas, fatigue, occasional headache, hay fever, or minor lower back or neck pain due to sensitivity to phenolic compounds found in foods or other products.*

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 In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Active Ingredient

ACTIVE INGREDIENTS Coumarin 9X, 12X, 30X, 60X

Inactive Ingredients

INACTIVE INGREDIENTS 20% ethanol, purified water.