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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.

BISMUTH: 180 Adverse Event Reports & Safety Profile

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180
Total FAERS Reports
67 (37.2%)
Deaths Reported
85
Hospitalizations
180
As Primary/Secondary Suspect
51
Life-Threatening
65
Disabilities
Boiron
Manufacturer

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?

#1 Most Reported
Nausea
51 reports (28.3%)
#2 Most Reported
Vomiting
48 reports (26.7%)
#3 Most Reported
Abdominal distension
46 reports (25.6%)

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

YearReportsDeathsHosp.
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

View full timeline →

What Is BISMUTH Used For?

IndicationReports
Helicobacter infection 87
Constipation 59
Product used for unknown indication 11
Chronic gastritis 5

BISMUTH vs Alternatives: Which Is Safer?

BISMUTH vs BISMUTH SUBCITRATE BISMUTH vs BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE BISMUTH vs BISMUTH SUBSALICYLATE BISMUTH vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE BISMUTH vs BISOPROLOL BISMUTH vs BISOPROLOL\BISOPROLOL BISMUTH vs BISOPROLOL\HYDROCHLOROTHIAZIDE BISMUTH vs BIVALIRUDIN BISMUTH vs BLEOMYCIN BISMUTH vs BLINATUMOMAB

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