MILK THISTLE: 76 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is MILK THISTLE Used For?
| Indication | Reports |
|---|---|
| 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.