Each 1 tsp serving contains: Bismuth 70 mcg. Other Ingredients: Glycerol, Potassium Sorbate, Purified Water.
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Below is general information about the effectiveness of the known ingredients contained in the product Bismuth. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Bismuth. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when bismuth subsalicylate or bismuth subgallate are used orally and appropriately, short-term. Bismuth subgallate 200-400 mg up to four times daily is approved by the US Food and Drug Administration (FDA) to be used as an internal deodorant (29965). Bismuth subsalicylate up to 4.2 grams daily for up to 2 days is approved by the US FDA to treat diarrhea (29966).
POSSIBLY SAFE ...when other forms of bismuth salts are used orally and appropriately, short-term. Bismuth salts, including ranitidine bismuth citrate, colloidal bismuth subcitrate, and bismuth subnitrate appear to be safe in doses of 400-2100 mg daily for up to 56 days (29957).
POSSIBLY UNSAFE ...when used orally in large amounts due to the risk of renal failure (25770,29947). ...when used orally over extended time periods due to the risk of neurotoxicity and encephalopathy (25770,25775,29942,29946).
CHILDREN: LIKELY SAFE
when bismuth subgallate is used orally and appropriately, short-term.
Oral bismuth subgallate 200-400 mg up to four times daily is approved by the US FDA to be used as an internal deodorant in children at least 12 years-old (29965). ...when bismuth subsalicylate is used orally and appropriately, short-term. Oral bismuth subsalicylate 1.05 grams hourly as needed (not to exceed 4.2 grams daily) for up to 2 days is approved by the US FDA to be used to treat diarrhea in children at least 12 years-old (29966). There is insufficient reliable information available about the safety of other bismuth salts when used orally.
CHILDREN: POSSIBLY UNSAFE
when used orally in large amounts or over prolonged time periods due to the risk of renal failure or encephalopathy (25770,25775,29942,29946,29947).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Bismuth. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, use of bismuth subgallate or other bismuth salts might reduce the effects of anticoagulant/antiplatelet drugs.
 Details
In humans, bismuth subgallate activates factor XII and accelerates the coagulation cascade (25774).
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Theoretically, bismuth subsalicylate might have an additive effect with other salicylate-containing drugs.
Details
Dietary supplements often contain bismuth in the form of bismuth subsalicylate. In humans, oral bismuth subsalicylate is hydrolyzed in the stomach to form salicylate and bismuth oxychloride (25775).
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Theoretically, concomitant use of bismuth and omeprazole may increase the effects and side effects of bismuth.
Details
In humans, omeprazole increases the absorption of bismuth from tripotassium dicitrato bismuthate. The area under the concentration-time curve (AUC) and urinary excretion (Ae) of bismuth have been shown to be higher when tripotassium dicitrato bismuthate is administered with omeprazole (172 ± 158 mcg/L/hour and 1.9 ± 2.0 mg per eight hours, respectively) compared with administration alone (46 ± 33 mcg/L/hour and 0.27 ± 0.28 mg per eight hours, respectively) (26347).
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There is some concern that bismuth subsalicylate might increase the effects of warfarin.
Details
In one case, a patient treated with warfarin had an increase in international normalized ratio (INR), from 2.56 to 3.54, following intake of bismuth subsalicylate 30 mL every 4 hours for 3 days. However, this interaction resulted from the displacement of warfarin from plasma protein binding sites by salicylate, which increased the free active form of warfarin (29945). Therefore, this interaction is not likely to occur with other bismuth salts.
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Below is general information about the adverse effects of the known ingredients contained in the product Bismuth. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, bismuth salts are generally well tolerated when taken alone or in combination with antibiotics.
Most Common Adverse Effects:
Orally: Change in taste perception, discolored stools or tongue, dizziness, gastrointestinal symptoms, such as nausea and diarrhea, and headache.
Serious Adverse Effects (Rare):
Orally: After large doses or chronic use, kidney failure and encephalopathy have been reported. Salicylate toxicity is also possible with use of bismuth subsalicylate specifically.
Dermatologic ...Orally, alopecia due to bismuth therapy has been reported (25797). A case of fixed drug eruption attributed to treatment with bismuth subcitrate has been confirmed with a drug challenge test (106809). Pruritus was a side effect in clinical trials investigating bismuth with antibiotics (26334,97823). However, the effect of bismuth alone is unclear.
Endocrine ...Orally, glandular atrophy was a side effect in a clinical trial investigating colloidal bismuth subcitrate taken in combination with tetracycline and furazolidone (26335). However, the effect of bismuth alone is unclear.
Gastrointestinal ...Orally, bismuth that is not absorbed is excreted in the feces as insoluble salts and may cause stools to appear grayish black (25770,26333,29957,101113). Also, bismuth may cause the tongue to turn black due to macular lingual pigmentation (26333,29943,29944,101113). Other side effects of bismuth therapy, typically when used in combination with other medications including antibiotics and proton-pump inhibitors (PPIs), include abdominal pain, constipation, chronic gastritis, diarrhea, nausea, vomiting, dry mouth, and intestinal metaplasia (26313,26322,26326,26327,26328,26329,26330,26331,26332,26333)(26334,26335,26336,26337,90291,97817,97823,97824,97825). However, when compared against non-bismuth containing regimens for Helicobacter pylori infection, the use of bismuth did not increase the risk of abdominal pain, nausea, vomiting, or diarrhea (29957).
Hematologic ...Orally, aplastic anemia has been reported as a potential side effect of bismuth salts (26338). Lymphoid follicles are a reported side effect in a clinical trial investigating colloidal bismuth subcitrate in combination with tetracycline and furazolidone (26335). However, the effect of bismuth alone is unclear. Excessive intake of bismuth subnitrate may cause methemoglobinemia (29947,29948).
Musculoskeletal ...Orally, body pains have occurred in a clinical trial examining the effect of tripotassium dicitrato bismuthate taken in combination with clarithromycin and lansoprazole (26322). However, the effect of bismuth alone is unclear.
Neurologic/CNS
...Orally, multiple cases of bismuth-related neurotoxicity have been reported (25775,29942).
In general, the risk of neurotoxicity from bismuth salts appears to be greater for colloidal bismuth than other forms due to the greater bioavailability of colloidal bismuth (25770). In most cases, the neurotoxicity results from excessive use of bismuth salts over prolonged time periods (up to 30 years) (25775,29946). Bismuth-related neurotoxicity often presents as encephalopathy that generally occurs in two phases (25770,29942). The first phase, which lasts for one week to several months, consists of nonspecific symptoms including depression, anxiety, irritability, phobias or delusions of persecution, somnolence, insomnia, hallucinations, headache, affect disorders, memory problems, attention disorders, and the inability to plan non-automatic activities. Unsteady gait, motor incoordination, and jerky movements may also occur (29942). During the second phase, most patients experience mental confusion, pseudo-tremor along with myoclonic jerks, walking and standing disturbances, and dysarthria (29942). The patients may also experience the inability to carry out simple instructions, sphincteric incontinence, muscle tone disturbances (hypotonia), and seizures (29942). Recovery from encephalopathy may take weeks to months.
Because bismuth subsalicylate is hydrolyzed in the stomach to form salicylate and bismuth oxychloride (25775), patients may present with salicylate toxicity following acute or chronic ingestion of bismuth subsalicylate (106807). In one case, a 79-year-old patient with chronic kidney disease presented with a 1-week history of worsening confusion, inattention, and ataxia following ingestion of bismuth subsalicylate 8.3-16.6 grams daily for 6 months. The patient improved with supportive care and with discontinuation of bismuth subsalicylate.
Orally, other side effects of bismuth therapy, typically when used in combination with other medications including antibiotics and proton-pump inhibitors (PPIs), include dizziness, headache, and fatigue (97817,97823,97824,97825). However, when compared against non-bismuth containing regimens for Helicobacter pylori infection, the use of bismuth did not increase the risk of dizziness or headache (29957).
Ocular/Otic ...Intravenously, a case of radio-opaque punctate opacities on chest radiographs following injection of bismuth compound has been reported (26343).
Renal ...Orally, cases of nephrotoxicity or acute kidney failure resulting from short-term exposure to high levels of bismuth salts, including colloidal bismuth subcitrate (De-Nol) and bismuth sodium triglycollamate (Bistrimate), have been reported (25770,29947). In one case, an adolescent experienced acute kidney failure, characterized by nausea, vomiting, and facial paresthesia, after consuming colloidal bismuth subcitrate (De-Nol) 18 grams in a single dose (25770). Although the patient underwent gastric lavage within 6 hours of ingesting the bismuth salt, multiple incidences of vomiting continued to occur daily for 9 days thereafter. The patient recovered after receiving the metal chelating agent penicillamine 20 mg/kg daily and undergoing hemodialysis therapy every other day or twice weekly until serum creatinine levels reached 2.1 mg/dL (25770). In another case, an adolescent experienced vomiting, tiredness, weakness, and elevated blood urea nitrogen (BUN) after ingesting bismuth sodium triglycollamate (Bistrimate) containing elemental bismuth 75 mg over a few hours (29947). Recovery from kidney failure may take weeks to months.
Other ...Orally, a bad or altered taste in the mouth has been reported. (26322,26326,26327,26328,26329,26330).
