Simethicone
Imodium Multi-symptom (simethicone) is a small molecule pharmaceutical. Simethicone was first approved as Imodium multi-symptom relief on 1996-06-26. It is used to treat flatulence in the USA.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Imodium multi-symptom (generic drugs available since 2006-09-06)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Loperamide hydrochloride
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Simethicone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IMODIUM MULTI-SYMPTOM RELIEF | Johnson & Johnson | N-021140 OTC | 2000-11-30 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| foster and thrive infants gas relief | OTC monograph final | 2023-06-12 |
| imodium | New Drug Application | 2021-09-27 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
91 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | B19.2 | 10 | 7 | 7 | 4 | 2 | 29 | |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 12 | 8 | 3 | 2 | 27 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 2 | — | — | 2 | ||
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepacivirus | D016174 | 12 | 2 | — | — | — | 14 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | 1 | — | — | 1 | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 12 | — | — | — | — | 12 | ||
| Viruses | D014780 | NCBITaxon_10239 | STY/T005 | 1 | — | — | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Hiv | D006678 | O98.7 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SIMETHICONE |
| INN | — |
| Description | Simeticone (INN), also known as simethicone (USAN), is an anti-foaming agent used to reduce bloating, discomfort or pain caused by excessive gas.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CO[Si](C)(C)O[Si](C)(C)C.O=[Si]=O |
Identifiers
| PDB | — |
| CAS-ID | 8050-81-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297192 |
| ChEBI ID | — |
| PubChem CID | 6433516 |
| DrugBank | DB09512 |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,189 adverse events reported
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