Loperamide
Imodium, Loperamide (loperamide) is a small molecule pharmaceutical. Loperamide was first approved as Imodium on 1982-01-01. It is used to treat bacillary dysentery, diarrhea, and functional colonic diseases in the USA. The pharmaceutical is active against mu-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Imodium, Loperamide (discontinued: Imodium, Loperamide)
CombinationsImodium 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
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | BionPharma | N-021855 OTC | 2005-08-04 | 2 products, RLD, RS |
| IMODIUM A-D | Johnson & Johnson | N-019487 OTC | 1988-03-01 | 2 products, RLD, RS |
| IMODIUM A-D | Johnson & Johnson | N-019860 OTC | 1989-11-22 | 1 products, RLD, RS |
Show 4 discontinued
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 |
|---|---|---|
| amazon basic care loperamide hydrochloride | ANDA | 2024-05-15 |
| anti diarrheal | ANDA | 2025-05-15 |
| anti diarrheal and anti gas | ANDA | 2024-07-22 |
| anti diarrheal anti gas | ANDA | 2025-06-27 |
| anti diarrheal plus anti gas | ANDA | 2024-07-11 |
| anti-diarrheal | ANDA | 2025-09-12 |
| anti-diarrheal, 24/7 life by 7-eleven | ANDA | 2025-06-19 |
| anti-diarrheal, caseys 4good anti-diarrheal, cvp health | ANDA | 2024-12-29 |
| anti-diarrheal, circle k | ANDA | 2024-12-29 |
| anti-diarrheal/anti-gas | ANDA | 2025-02-27 |
Show 53 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diarrhea | — | D003967 | R19.7 |
| bacillary dysentery | — | D004405 | A03 |
| functional colonic diseases | — | D003109 | — |
| flatulence | — | D005414 | R14.3 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
106 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | D003967 | — | R19.7 | 3 | 7 | 8 | 7 | 5 | 27 |
| Syndrome | D013577 | — | — | — | — | 2 | 1 | 9 | 12 |
| Fecal incontinence | D005242 | — | R15 | — | 1 | 2 | 1 | 4 | 7 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | 1 | 1 | 4 | 6 |
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | 1 | 3 | 1 | 1 | — | 4 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | 1 | — | 2 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | — | 1 | — | 1 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | — | — | 1 | — | 1 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 12 | 1 | — | 3 | 18 |
| Neoplasms | D009369 | — | C80 | 2 | 4 | 2 | — | 1 | 8 |
| Low anterior resection syndrome | D000094123 | — | — | — | — | 1 | — | 6 | 7 |
| Rectal neoplasms | D012004 | — | — | — | — | 2 | — | 4 | 6 |
| Colorectal neoplasms | D015179 | — | — | — | 3 | 1 | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 2 | 1 | — | — | 3 |
| Short bowel syndrome | D012778 | — | K90.82 | — | — | 3 | — | — | 3 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | — | 2 | 1 | — | — | 2 |
| Virus diseases | D014777 | — | B34 | — | 2 | 1 | — | — | 2 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | 1 | — | — | 1 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | 1 | 4 |
| Alveolar soft part sarcoma | D018234 | — | — | — | 2 | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 1 | 1 | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 1 | — | — | — | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | 1 | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | 2 | 9 |
| Dysentery | D004403 | EFO_1001869 | — | 1 | — | — | — | 1 | 2 |
| Intestinal obstruction | D007415 | — | K56.60 | 2 | — | — | — | — | 2 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | — | 1 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | 1 | — | — | — | — | 1 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 2 | 2 |
| Fever | D005334 | — | R50.9 | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | — | — | — | 1 | 1 |
| Digestive system neoplasms | D004067 | — | — | — | — | — | — | 1 | 1 |
| Gastrointestinal transit | D005772 | — | — | — | — | — | — | 1 | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Loperamide |
| INN | loperamide |
| Description | Loperamide is a synthetic piperidine derivative, effective against diarrhoea resulting from gastroenteritis or inflammatory bowel disease. It has a role as a mu-opioid receptor agonist, an antidiarrhoeal drug and an anticoronaviral agent. It is a member of piperidines, a monocarboxylic acid amide, a member of monochlorobenzenes and a tertiary alcohol. It is a conjugate base of a loperamide(1+). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)C(=O)C(CCN1CCC(O)(c2ccc(Cl)cc2)CC1)(c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 53179-11-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL841 |
| ChEBI ID | 6532 |
| PubChem CID | 3955 |
| DrugBank | DB00836 |
| UNII ID | 6X9OC3H4II (ChemIDplus, GSRS) |
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Loperamide
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Loperamide
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Simethicone
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Safety
Black-box Warning
Black-box warning for: Loperamide hydrochloride
Adverse Events
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25,808 adverse events reported
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