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METOCLOPRAMIDE HYDROCHLORIDE
Metoclopramide enhances gastrointestinal motility by increasing muscle tone and peristalsis without affecting secretions.
At a glance
| Generic name | METOCLOPRAMIDE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1979 |
Mechanism of action
Metoclopramide works by stimulating the muscles in the upper gastrointestinal tract, which helps food move through the stomach and intestines more quickly. This action is achieved by increasing the tone and strength of muscle contractions in the stomach and enhancing the movement of the small intestine, while also relaxing the pyloric sphincter and duodenal bulb. It does not affect the colon or gallbladder.
Approved indications
Boxed warnings
- WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [see Warnings and Precautions (5.1) ] . Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1) and Dosage and Administration (2.2 , 2.3) ]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage ( 5.1 ) Discontinue metoclopramide in patients who develop signs or symptoms of TD ( 5.1 ) Avoid treatment with metoclopramide for longer than 12 weeks because of the risk of developing TD with longer-term use ( 5.1 , 2.1 , 2.2 , 2.3 )
Common side effects
- restlessness
- drowsiness
- fatigue
- lassitude
Key clinical trials
- Restoration of Hypoglycemia Awareness With Metoclopramide (PHASE2)
- A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults (PHASE1)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting (PHASE3)
- Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy (PHASE4)
- IV Injection of Metoclopramide With or Without Dexamethasone (EARLY_PHASE1)
- Antibiotics and Vaccine Immune Responses Study (PHASE4)
- Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- METOCLOPRAMIDE HYDROCHLORIDE CI brief — competitive landscape report
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