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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 SUBSALICYLATE: 401 Adverse Event Reports & Safety Profile

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401
Total FAERS Reports
84 (20.9%)
Deaths Reported
130
Hospitalizations
401
As Primary/Secondary Suspect
31
Life-Threatening
38
Disabilities
Marc Glassman, Inc.
Manufacturer

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

First Report: 20030101 · Latest Report: 20250903

What Are the Most Common BISMUTH SUBSALICYLATE Side Effects?

#1 Most Reported
Nausea
75 reports (18.7%)
#2 Most Reported
Diarrhoea
75 reports (18.7%)
#3 Most Reported
Drug ineffective
72 reports (18.0%)

All BISMUTH SUBSALICYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 75 18.7% 0 17
Nausea 75 18.7% 24 35
Drug ineffective 72 18.0% 15 20
Faeces discoloured 56 14.0% 0 18
Constipation 53 13.2% 25 28
Abdominal pain 49 12.2% 25 32
Vomiting 48 12.0% 24 28
Abdominal distension 41 10.2% 31 33
Off label use 38 9.5% 19 24
Toxicity to various agents 35 8.7% 14 24
Intentional product misuse 34 8.5% 28 28
Drug hypersensitivity 33 8.2% 20 21
Dyspnoea 33 8.2% 16 21
Ascites 32 8.0% 25 27
Condition aggravated 32 8.0% 24 20
Hyponatraemia 32 8.0% 25 28
Ventricular fibrillation 29 7.2% 29 25
Somnolence 28 7.0% 24 24
Death 27 6.7% 27 18
Headache 26 6.5% 4 11

Who Reports BISMUTH SUBSALICYLATE Side Effects? Age & Gender Data

Gender: 52.2% female, 47.8% male. Average age: 59.8 years. Most reports from: US. View detailed demographics →

Is BISMUTH SUBSALICYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2007 1 0 1
2009 2 0 0
2011 1 0 0
2012 3 0 2
2013 2 0 0
2015 9 0 7
2016 15 2 3
2017 20 0 5
2018 18 6 3
2019 20 0 7
2020 22 9 11
2021 13 3 2
2022 15 3 3
2023 11 0 3
2024 16 0 4
2025 10 0 1

View full timeline →

What Is BISMUTH SUBSALICYLATE Used For?

IndicationReports
Product used for unknown indication 114
Diarrhoea 66
Constipation 26
Helicobacter infection 19
Dyspepsia 18
Gastrooesophageal reflux disease 14
Nausea 13
Abdominal discomfort 11
Colitis microscopic 10
Irritable bowel syndrome 7

BISMUTH SUBSALICYLATE vs Alternatives: Which Is Safer?

BISMUTH SUBSALICYLATE vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE BISMUTH SUBSALICYLATE vs BISOPROLOL BISMUTH SUBSALICYLATE vs BISOPROLOL\BISOPROLOL BISMUTH SUBSALICYLATE vs BISOPROLOL\HYDROCHLOROTHIAZIDE BISMUTH SUBSALICYLATE vs BIVALIRUDIN BISMUTH SUBSALICYLATE vs BLEOMYCIN BISMUTH SUBSALICYLATE vs BLINATUMOMAB BISMUTH SUBSALICYLATE vs BLONANSERIN BISMUTH SUBSALICYLATE vs --BLOOD-COAGULATION FACTOR VIII FUSION PROTEIN WITH IMMUNOGLOBULIN G1 , ,-BIS WITH IMMUNOGLOBULIN G1 BISMUTH SUBSALICYLATE vs BOCEPREVIR

Other Drugs in Same Class: Bismuth [CS]

Official FDA Label for BISMUTH SUBSALICYLATE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses relieves traveler's diarrhea diarrhea upset stomach reliever due to overindulgence in food and drink, including:

  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

Dosage & Administration

Directions chew or dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) 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 Directions chew or dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) 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 Warnings Reye’s syndrome 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 Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient

Active ingredient & Purposes Active ingredient (in each 30 mL dose cup or 2 tablespoons)

Purposes

Bismuth subsalicylate 525 mg................. Upset stomach reliever and antidiarrhea

Inactive Ingredients

Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.