Metoclopramide
Gimoti, Metoclopramide, Reglan (metoclopramide) is a small molecule pharmaceutical. Metoclopramide was first approved as Reglan on 1982-01-01. It is used to treat gastroesophageal reflux, gastroparesis, and postoperative nausea and vomiting in the USA. The pharmaceutical is active against 5-hydroxytryptamine receptor 4 and D(2) dopamine receptor.
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Gimoti, Metoclopramide, Reglan (discontinued: Maxolon, Metoclopramide, Metozolv, Reglan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metoclopramide hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REGLAN | ANI Pharmaceuticals | N-017854 RX | 1982-01-01 | 2 products, RLD, RS |
| GIMOTI | Evoke Pharma | N-209388 RX | 2020-06-19 | 1 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gimoti | New Drug Application | 2021-01-07 |
| metoclopramide | ANDA | 2024-10-11 |
| metoclopramide hydrochloride | ANDA | 2024-10-22 |
| reglan | New Drug Application | 2020-06-19 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J2765 | Injection, metoclopramide hcl, up to 10 mg |
Clinical
Clinical Trials
200 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 3 | 11 | 15 | 9 | 37 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 3 | 8 | 14 | 6 | 30 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 1 | 5 | 13 | 9 | 28 |
| Headache | D006261 | HP_0002315 | R51 | 1 | 6 | 6 | 6 | 9 | 25 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 2 | 5 | 6 | 13 |
| Gastrointestinal hemorrhage | D006471 | HP_0002239 | K92.2 | 1 | 1 | 2 | 3 | 1 | 8 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | 2 | 3 | — | 7 |
| Critical illness | D016638 | — | — | 1 | 3 | — | 1 | 3 | 7 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | 2 | 2 | 1 | 6 |
| Emergencies | D004630 | — | — | — | — | 2 | 2 | 2 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 4 | 2 | — | 2 | 8 |
| Headache disorders | D020773 | EFO_0009550 | G44 | — | — | 1 | — | 1 | 2 |
| Breast feeding | D001942 | — | — | — | — | 1 | — | 1 | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | 1 | — | — | 1 |
| Sialorrhea | D012798 | HP_0002307 | K11.7 | — | — | 1 | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | 1 | — | — | 1 |
| Gastroschisis | D020139 | EFO_1000949 | Q79.3 | — | — | 1 | — | — | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | 1 | — | — | 1 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | 1 | — | — | — | 3 |
| Hyperemesis gravidarum | D006939 | EFO_1000971 | O21 | — | 2 | — | — | 1 | 3 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | 1 | 2 |
| Intestinal obstruction | D007415 | — | K56.60 | 1 | 2 | — | — | — | 2 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 1 | — | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 2 | — | — | — | 2 |
| Enteral nutrition | D004750 | — | — | — | 2 | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | 2 | 3 |
| Inborn errors metabolism | D008661 | — | — | 1 | — | — | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | — | — | — | — | 1 |
| Primary dysautonomias | D054969 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstetric labor complications | D007744 | — | — | — | — | — | — | 2 | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | — | — | — | 1 | 1 |
| Rhytidoplasty | D015361 | — | — | — | — | — | — | 1 | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | — | — | 1 | 1 |
| Labor pain | D048949 | — | — | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | — | 1 | 1 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Metoclopramide |
| INN | metoclopramide |
| Description | Metoclopramide is a member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine. It has a role as an antiemetic, a dopaminergic antagonist, a gastrointestinal drug, a xenobiotic and an environmental contaminant. It is a tertiary amino compound, a substituted aniline, a member of benzamides and a member of monochlorobenzenes. It is a conjugate base of a metoclopramide(1+). |
| Classification | Small molecule |
| Drug class | D2 receptor antagonist; 5-HT3 receptor antagonist; 5-HT4 receptor agonist; Prolactin releaser |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC |
Identifiers
| PDB | — |
| CAS-ID | 364-62-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL86 |
| ChEBI ID | 107736 |
| PubChem CID | 4168 |
| DrugBank | DB01233 |
| UNII ID | L4YEB44I46 (ChemIDplus, GSRS) |
Target
Agency Approved
HTR4
HTR4
DRD2
DRD2
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Metoclopramide
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Trends
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Safety
Black-box Warning
Black-box warning for: Gimoti, Metoclopramide, Metoclopramide hydrochloride, Reglan
Adverse Events
Top Adverse Reactions
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32,737 adverse events reported
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