Bismuth subsalicylate
/ / (bismuth subsalicylate) is a small molecule pharmaceutical. Bismuth subsalicylate was first approved as Helidac on 1996-08-15. It is used to treat bacillary dysentery, diarrhea, dyspepsia, escherichia coli infections, and helicobacter infections amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Bismuth subsalicylate, metronidazole tetracycline (discontinued: Helidac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bismuth subsalicylate
+
Metronidazole
+
Tetracycline hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HELIDAC | Casper Pharma | N-050719 DISCN | 1996-08-15 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 24 / 7 life stomach relief | OTC monograph final | 2023-07-19 |
| 5 symptom digestive relief | C200263 | 2024-05-25 |
| 5-symptom digestive relief | C200263 | 2024-06-26 |
| anti-diarrheal | C200263 | 2024-03-27 |
| bismatrol | C200263 | 2024-01-01 |
| bismuth | OTC monograph final | 2022-06-11 |
| bismuth chewable | C200263 | 2016-12-19 |
| bismuth subsalicylate | C200263 | 2024-06-10 |
| bismuth subsalicylate 262 mg | OTC monograph final | 2023-03-29 |
| bismuth subsalicylate/metronidazole/tetracycline hydrochloride | ANDA | 2019-11-24 |
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Indications
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Agency Specific
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Patent Expiration
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Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | — | 2 | 2 | 6 | 3 | 12 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | 5 | — | 7 |
| Analgesia | D000698 | — | — | — | — | — | 1 | 2 | 3 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | 1 | 1 | 3 |
| Ileus | D045823 | — | — | 1 | — | — | 1 | — | 2 |
| Paralysis | D010243 | HP_0003470 | — | — | — | — | 1 | — | 1 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | — | 1 | — | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | — | 1 |
| Flatulence | D005414 | — | R14.3 | — | — | — | 1 | — | 1 |
| Covid-19 | D000086382 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | 1 | 2 |
| Post-dural puncture headache | D051299 | — | — | — | — | 1 | — | 1 | 2 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | 1 | 1 | — | — | 1 |
| Genital diseases | D000091662 | — | — | — | 1 | 1 | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | 1 | — | — | 1 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | — | 1 | — | — | 1 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 1 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | 1 | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 1 | — | — | — | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | — | — | 1 | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | — | 1 |
| Second primary neoplasms | D016609 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | — | — | — | 2 | 2 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | — | — | 1 | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bismuth subsalicylate |
| INN | — |
| Description | Bismuth subsalicylate is a bismuth salt of salicylic acid. It is a member of salicylates and a bismuth coordination entity. |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (salicylic acid derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 14882-18-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1120 |
| ChEBI ID | 261649 |
| PubChem CID | 16682734 |
| DrugBank | DB01294 |
| UNII ID | — |
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Bismuth subsalicylate
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Trends
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Safety
Black-box Warning
Black-box warning for: Bismuth subsalicylate/metronidazole/tetracycline hydrochloride, Helidac therapy
Adverse Events
Top Adverse Reactions
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790 adverse events reported
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