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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 SUBNITRATE: 81 Adverse Event Reports & Safety Profile

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81
Total FAERS Reports
81 (100.0%)
Deaths Reported
73
Hospitalizations
81
As Primary/Secondary Suspect
63
Life-Threatening
74
Disabilities
Hahnemann Laboratories, INC.
Manufacturer

Drug Class: Bismuth [CS] · Route: ORAL · Manufacturer: Hahnemann Laboratories, INC. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20200101 · Latest Report: 20210605

What Are the Most Common BISMUTH SUBNITRATE Side Effects?

#1 Most Reported
Off label use
61 reports (75.3%)
#2 Most Reported
Stress
59 reports (72.8%)
#3 Most Reported
Hyponatraemia
59 reports (72.8%)

All BISMUTH SUBNITRATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 61 75.3% 61 53
Hyponatraemia 59 72.8% 59 51
Stress 59 72.8% 59 51
Multiple organ dysfunction syndrome 58 71.6% 58 50
Condition aggravated 57 70.4% 57 51
General physical health deterioration 57 70.4% 57 49
Myasthenia gravis 57 70.4% 57 52
Sepsis 57 70.4% 57 49
Somnolence 57 70.4% 57 51
Abdominal distension 51 63.0% 51 44
Incorrect route of product administration 49 60.5% 49 45
Vomiting 49 60.5% 49 42
Appendicitis 48 59.3% 48 41
Ascites 48 59.3% 48 41
Ventricular fibrillation 48 59.3% 48 41
Abdominal pain 47 58.0% 47 40
Appendicolith 47 58.0% 47 40
Cardiogenic shock 47 58.0% 47 40
Diabetes mellitus 47 58.0% 47 44
Drug hypersensitivity 47 58.0% 47 44

Who Reports BISMUTH SUBNITRATE Side Effects? Age & Gender Data

Gender: 0.0% female, 100.0% male. Average age: 80.0 years. Most reports from: CA. View detailed demographics →

Is BISMUTH SUBNITRATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2020 21 21 20
2021 2 2 1

View full timeline →

What Is BISMUTH SUBNITRATE Used For?

IndicationReports
Constipation 67
Product used for unknown indication 14

Other Drugs in Same Class: Bismuth [CS]

BISMUTH SUBSALICYLATE (401) BISMUTH (180) BISMUTH SUBGALLATE (21) View all → Class side effects → Compare in class →

Official FDA Label for BISMUTH SUBNITRATE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses: See symptoms on front panel. Relieves stomach aches, sour stomach and vomiting *

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.

Active Ingredient

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

Inactive Ingredients

lactose, sucrose