BISMUTH: 180 Adverse Event Reports & Safety Profile
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Drug Class: Bismuth [CS] · Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available
First Report: 20140220 · Latest Report: 20240924
What Are the Most Common BISMUTH Side Effects?
All BISMUTH Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 51 | 28.3% | 42 | 35 |
| Vomiting | 48 | 26.7% | 45 | 34 |
| Abdominal distension | 46 | 25.6% | 46 | 34 |
| Abdominal pain | 45 | 25.0% | 43 | 33 |
| Ascites | 44 | 24.4% | 43 | 32 |
| Off label use | 44 | 24.4% | 42 | 30 |
| Appendicitis | 43 | 23.9% | 43 | 31 |
| Appendicolith | 43 | 23.9% | 43 | 31 |
| Blood phosphorus increased | 43 | 23.9% | 43 | 31 |
| Constipation | 43 | 23.9% | 42 | 30 |
| Hyponatraemia | 43 | 23.9% | 42 | 31 |
| Condition aggravated | 42 | 23.3% | 42 | 31 |
| Dry mouth | 42 | 23.3% | 41 | 30 |
| Somnolence | 42 | 23.3% | 42 | 31 |
| Ventricular fibrillation | 41 | 22.8% | 41 | 29 |
| General physical health deterioration | 40 | 22.2% | 40 | 28 |
| Stress | 40 | 22.2% | 40 | 28 |
| Cardiogenic shock | 38 | 21.1% | 38 | 26 |
| Multiple organ dysfunction syndrome | 38 | 21.1% | 38 | 26 |
| Sepsis | 38 | 21.1% | 38 | 26 |
Who Reports BISMUTH Side Effects? Age & Gender Data
Gender: 33.7% female, 66.3% male. Average age: 67.4 years. Most reports from: CA. View detailed demographics →
Is BISMUTH Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 2 | 0 | 2 |
| 2015 | 3 | 0 | 1 |
| 2017 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 1 |
| 2019 | 2 | 0 | 0 |
| 2020 | 22 | 17 | 17 |
| 2021 | 10 | 4 | 3 |
| 2022 | 5 | 0 | 1 |
| 2023 | 12 | 0 | 7 |
| 2024 | 11 | 0 | 4 |
What Is BISMUTH Used For?
| Indication | Reports |
|---|---|
| Helicobacter infection | 87 |
| Constipation | 59 |
| Product used for unknown indication | 11 |
| Chronic gastritis | 5 |
BISMUTH vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Bismuth [CS]
Official FDA Label for BISMUTH
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses relieves:
- travelers' diarrhea
- diarrhea
- upset stomach due to
- overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
Dosage & Administration
Directions
- swallow with water, do not chew
- adults and children 12 years and over:
- 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
- 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 softgels) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Warnings
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Active Ingredient
Bismuthum metallicum 200CK HPUS Active ingredient**: See product name on front panel (**contains 0.443 mg of the active ingredient per pellet).
Inactive Ingredients
Inactive ingredients FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, sorbitan, sorbitol solution*, purified water, titanium dioxide *may contain these ingredients