Bismuth subsalicylate
Helidac (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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Bismuth subsalicylate
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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 |
|---|---|---|
| foster and thrive stomach relief | OTC monograph final | 2023-06-20 |
| helidac therapy | ANDA | 2020-06-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacillary dysentery | — | D004405 | A03 |
| diarrhea | HP_0002014 | D003967 | R19.7 |
| dyspepsia | EFO_0008533 | D004415 | K30 |
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
| helicobacter infections | EFO_1000961 | D016481 | — |
| nausea | HP_0002018 | D009325 | R11.0 |
| stomach diseases | — | D013272 | — |
| virus diseases | — | D014777 | B34 |
Agency Specific
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Clinical
Clinical Trials
26 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 | 5 | 1 | 9 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | 1 | 1 | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | 2 | — | 2 | |
| Ileus | D045823 | K56.7 | 1 | — | — | 1 | — | 2 | |
| Analgesia | D000698 | — | — | — | 1 | — | 1 | ||
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | 1 | — | 1 | |
| Flatulence | D005414 | R14.3 | — | — | — | 1 | — | 1 | |
| Covid-19 | D000086382 | U07.1 | — | — | — | 1 | — | 1 | |
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Palliative care | D010166 | — | — | — | — | 1 | 1 | ||
| Iron deficiencies | D000090463 | E61.1 | — | — | — | — | 1 | 1 |
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) | O=C([O-])c1ccccc1[O-].[Bi+3].[OH-] |
Identifiers
| PDB | — |
| CAS-ID | 14882-18-9 |
| RxCUI | 19478 |
| ChEMBL ID | CHEMBL1120 |
| ChEBI ID | 261649 |
| PubChem CID | 16682734 |
| DrugBank | DB01294 |
| UNII ID | — |
Target
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Variants
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Trends
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Safety
Black-box Warning
Black-box warning for: Helidac therapy
Adverse Events
Top Adverse Reactions
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2,412 adverse events reported
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