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Drug ReportsBismuth subsalicylate
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
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
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
HELIDACCasper PharmaN-050719 DISCN1996-08-15
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
24 / 7 life stomach reliefOTC monograph final2023-07-19
anti-diarrhealOTC monograph final2023-03-25
bismatrolC2002632024-01-01
bismuthOTC monograph final2022-06-11
bismuth chewableOTC monograph final2016-12-19
bismuth subsalicylateC2002632024-02-01
bismuth subsalicylate 262 mgOTC monograph final2023-03-29
bismuth subsalicylate/metronidazole/tetracycline hydrochlorideANDA2019-11-24
bismutinaOTC monograph final2021-04-28
chewableOTC monograph final2011-11-26
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
59 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConstipationD003248HP_0002019K59.022519
InfectionsD007239EFO_000054444
AnalgesiaD000698123
DiarrheaD003967HP_0002014R19.71113
IleusD045823K56.7112
Morbid obesityD009767EFO_000107411
FlatulenceD005414R14.311
Covid-19D000086382U07.111
Clostridium infectionsD003015EFO_1000874A05.211
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Female genital diseasesD005831EFO_0009549N85111
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.911
DyspneaD004417HP_0002094R06.011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289112
Parkinson diseaseD010300EFO_0002508G20212
Multiple myelomaD009101C90.011
Spinal cord injuriesD013119EFO_1001919111
LymphomaD008223C85.911
GastroparesisD018589EFO_1000948K31.8411
GlioblastomaD005909EFO_0000515111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Premature birthD047928EFO_0003917O6011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ischemic strokeD00008324211
StrokeD020521EFO_0000712I63.911
Intracranial arteriosclerosisD002537EFO_1000860I67.211
MicrobiotaD06430711
Liver diseasesD008107HP_0002910K70-K7711
Liver cirrhosisD008103EFO_0001422K74.011
Liver neoplasmsD008113EFO_1001513C22.011
Postoperative painD010149G89.1811
Macular edemaD00826911
Retinal vein occlusionD012170EFO_1001157H34.8111
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBismuth 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 classanti-inflammatory agents (salicylic acid derivatives)
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Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID14882-18-9
RxCUI
ChEMBL IDCHEMBL1120
ChEBI ID261649
PubChem CID16682734
DrugBankDB01294
UNII ID
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
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Estimated US medical usage
Bismuth subsalicylate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 1,489 documents
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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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649 adverse events reported
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