Simethicone
Imodium Multi-symptom, Loperamide / Simethicone (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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Imodium multi-symptom, Loperamide simethicone (discontinued: Imodium multi-symptom, Loperamide simethicone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Loperamide hydrochloride
+
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 |
|---|---|---|
| alka-seltzer heartburn plus gas reliefchews tropical punch | C200263 | 2023-12-04 |
| almacone | OTC monograph final | 2010-12-01 |
| aluminum hydroxide, magnesium hydroxide and simethicone | C200263 | 2024-10-17 |
| aluminum hydroxide, magnesium hydroxide and simethicone suspension aluminum hydroxide, magnesium hydroxide and simethicone suspension maximum strength | OTC monograph final | 2023-08-01 |
| alumox | OTC monograph final | 2020-01-17 |
| antacid | C200263 | 2024-08-05 |
| antacid and antigas | OTC monograph final | 2019-11-04 |
| antacid and gasrelief | C200263 | 2023-11-07 |
| antacid antigas | C200263 | 2024-07-02 |
| antacid cherry flavored | OTC monograph final | 2018-04-30 |
Show 184 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diarrhea | HP_0002014 | D003967 | R19.7 |
| bacillary dysentery | — | D004405 | A03 |
| flatulence | — | D005414 | R14.3 |
| functional colonic diseases | — | D003109 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | 1 | 1 | 10 |
| Colonoscopy | D003113 | — | — | — | — | 2 | 4 | 2 | 8 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | — | — | 3 | 2 | 6 |
| Capsule endoscopy | D053704 | — | — | — | — | — | 1 | 4 | 5 |
| Colic | D003085 | HP_0011848 | R10.83 | — | 2 | — | 1 | 2 | 5 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | 1 | 2 | 1 | 5 |
| Colonic polyps | D003111 | — | K63.5 | — | — | 1 | 2 | 2 | 5 |
| Syndrome | D013577 | — | — | — | 1 | — | 2 | 2 | 5 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 1 | 1 | 2 | — | 4 |
| Adenoma | D000236 | — | — | — | — | — | 2 | 2 | 4 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal diseases | D005767 | — | — | — | 2 | 1 | — | 3 | 6 |
| Colorectal neoplasms | D015179 | — | — | — | — | 1 | — | 4 | 5 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | — | 2 | — | 1 | 4 |
| Stomach diseases | D013272 | — | — | — | 1 | 1 | — | 2 | 4 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | 1 | — | — | 2 |
| Gastrointestinal hemorrhage | D006471 | HP_0002239 | K92.2 | 1 | — | 1 | — | — | 2 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | 1 | 1 | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | 2 | — | — | 2 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 2 | 2 | — | — | 2 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | 2 | — | — | 3 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 1 | — | — | 1 | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | 1 | — | — | — | 1 |
| Pathologic complete response | D000095384 | — | — | — | 1 | — | — | — | 1 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 1 | — | — | — | 1 |
| Otitis | D010031 | — | — | — | 1 | — | — | — | 1 |
| Diabetes complications | D048909 | — | — | — | 1 | — | — | — | 1 |
| Macular edema | D008269 | — | — | — | 1 | — | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Abdominal pain | D015746 | HP_0002027 | R10.9 | 1 | — | — | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
| Brain concussion | D001924 | — | S06.0 | 1 | — | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | — | — | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mitral valve insufficiency | D008944 | HP_0001653 | — | — | — | — | — | 1 | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 1 | 1 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | — | — | — | 1 | 1 |
| Cough | D003371 | HP_0012735 | R05 | — | — | — | — | 1 | 1 |
| Chronic cough | D000096822 | — | — | — | — | — | — | 1 | 1 |
| Rectal neoplasms | D012004 | — | — | — | — | — | — | 1 | 1 |
| Polyps | D011127 | EFO_0000662 | — | — | — | — | — | 1 | 1 |
| Gastroscopy | D005773 | — | — | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | — | — | — | — | — | 1 | 1 |
| Lactose intolerance | D007787 | HP_0004789 | E73 | — | — | — | — | 1 | 1 |
Show 9 more
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) | — |
Identifiers
| PDB | — |
| CAS-ID | 8050-81-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297192 |
| ChEBI ID | — |
| PubChem CID | 6433516 |
| DrugBank | DB09512 |
| UNII ID | — |
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Estimated US medical usage
Simethicone
+
Loperamide
Total medical expenditures per year (USD, in millions)
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Simethicone
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Trends
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Safety
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Adverse Events
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5,354 adverse events reported
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