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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.

MILK THISTLE: 76 Adverse Event Reports & Safety Profile

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76
Total FAERS Reports
21 (27.6%)
Deaths Reported
47
Hospitalizations
76
As Primary/Secondary Suspect
6
Life-Threatening
4
Disabilities
Boiron
Manufacturer

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

First Report: 20011128 · Latest Report: 20240816

What Are the Most Common MILK THISTLE Side Effects?

#1 Most Reported
Off label use
20 reports (26.3%)
#2 Most Reported
Pulmonary oedema
15 reports (19.7%)
#3 Most Reported
Hypertension
15 reports (19.7%)

All MILK THISTLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 20 26.3% 10 12
Hypertension 15 19.7% 14 7
Pulmonary oedema 15 19.7% 15 6
Acute respiratory failure 14 18.4% 14 6
Brain oedema 14 18.4% 14 6
Cardiovascular insufficiency 14 18.4% 14 6
Confusional state 14 18.4% 14 6
Covid-19 pneumonia 14 18.4% 14 6
Embolism 14 18.4% 14 6
Encephalopathy 14 18.4% 14 6
Hallucination 14 18.4% 14 6
Hypoxia 14 18.4% 14 6
Tachypnoea 14 18.4% 14 6
Fall 11 14.5% 0 10
Intentional product use issue 10 13.2% 10 5
Vomiting 9 11.8% 0 7
Depression 8 10.5% 0 6
Decreased appetite 7 9.2% 0 5
Dry mouth 7 9.2% 0 6
Gait disturbance 7 9.2% 0 5

Who Reports MILK THISTLE Side Effects? Age & Gender Data

Gender: 47.4% female, 52.6% male. Average age: 50.7 years. Most reports from: BG. View detailed demographics →

Is MILK THISTLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 2
2011 2 0 0
2013 1 0 1
2014 1 0 1
2015 3 0 0
2016 8 0 7
2017 2 0 1
2018 1 0 0
2020 14 14 6
2021 3 0 3
2022 1 1 0
2024 3 0 3

View full timeline →

What Is MILK THISTLE Used For?

IndicationReports
Product used for unknown indication 46

Official FDA Label for MILK THISTLE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

USE: To be used according to standard homeopathic indications.

Dosage & Administration

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Warnings

WARNINGS: Keep out of reach of children. If pregnant or breast-feeding, ask a health care professional before use. Stop use and ask a health care professional if symptoms persist for more than 3 days or worsen. Keep out of reach of children.

Active Ingredient

Carduus marianus 200CK HPUS Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

Inactive Ingredients

INACTIVE INGREDIENTS: Organic sucrose, lactose free.