BISMUTH SUBGALLATE: 21 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 4 | 0 | 3 |
| 2023 | 2 | 0 | 1 |
What Is BISMUTH SUBGALLATE Used For?
| Indication | Reports |
|---|---|
| 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.