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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 SUBGALLATE: 21 Adverse Event Reports & Safety Profile

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21
Total FAERS Reports
15 (71.4%)
Deaths Reported
19
Hospitalizations
21
As Primary/Secondary Suspect
17
Life-Threatening
15
Disabilities
The Parthenon Co., Inc.
Manufacturer

Drug Class: Bismuth [CS] · Route: ORAL · Manufacturer: The Parthenon Co., Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 2019 · Latest Report: 20230929

What Are the Most Common BISMUTH SUBGALLATE Side Effects?

#1 Most Reported
Vomiting
9 reports (42.9%)
#2 Most Reported
Abdominal distension
9 reports (42.9%)
#3 Most Reported
Dyspnoea
8 reports (38.1%)

All BISMUTH SUBGALLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Abdominal distension 9 42.9% 9 9
Vomiting 9 42.9% 8 9
Blood uric acid increased 8 38.1% 8 8
Dyspnoea 8 38.1% 8 8
Product use in unapproved indication 7 33.3% 6 7
Stress 7 33.3% 7 7
Abdominal pain 6 28.6% 6 6
Anaemia 6 28.6% 6 6
Appendicitis 6 28.6% 6 6
Appendicolith 6 28.6% 6 6
Ascites 6 28.6% 6 6
Bacterial infection 6 28.6% 6 6
Blood cholesterol increased 6 28.6% 6 6
Blood phosphorus increased 6 28.6% 6 6
Chronic obstructive pulmonary disease 6 28.6% 6 6
Condition aggravated 6 28.6% 6 6
Diabetes mellitus 6 28.6% 6 6
Drug hypersensitivity 6 28.6% 6 6
Hyperphosphataemia 6 28.6% 6 6
Hyponatraemia 6 28.6% 6 6

Who Reports BISMUTH SUBGALLATE Side Effects? Age & Gender Data

Gender: 20.0% female, 80.0% male. Average age: 71.7 years. Most reports from: CA. View detailed demographics →

Is BISMUTH SUBGALLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 4 0 3
2023 2 0 1

View full timeline →

What Is BISMUTH SUBGALLATE Used For?

IndicationReports
Constipation 15

Other Drugs in Same Class: Bismuth [CS]

Official FDA Label for BISMUTH SUBGALLATE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use for eliminating or reducing odor from flatulence (gas) and stool (feces).

Dosage & Administration

Directions Adults and children 12 years and over: 1 to 2 capsules up to four times daily or as directed by physician. Do not exceed 8 capsules in 24 hours. Children under 12 years: ask a doctor.

Warnings

Warnings If pregnant or breast-feeding , ask a health professional before use. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children .

Active Ingredient

Active ingredient (in each capsule) Bismuth subgallate 200 mg

Inactive Ingredients

Inactive ingredients magnesium stearate, microcrystalline cellulose, natural banana flavor. starch, talc, xylitol.