BISMUTH SUBSALICYLATE: 401 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is BISMUTH SUBSALICYLATE Used For?
| Indication | Reports |
|---|---|
| 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?
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.