Last reviewed · How we verify
Reglan (METOCLOPRAMIDE)
Reglan (Metoclopramide) is a dopamine-2 receptor antagonist developed by Baxter Healthcare Corp and currently owned by Hikma. It was first approved by the FDA in 1979 for various gastrointestinal indications, including chemotherapy-induced nausea and vomiting, diabetic gastroparesis, and gastroesophageal reflux disease. Reglan works by targeting the D(3) dopamine receptor, which helps to regulate gastrointestinal motility. As an off-patent medication with 38 generic manufacturers, Reglan is widely available. Key safety considerations include its potential for extrapyramidal side effects and the risk of serotonin syndrome when used with certain antidepressants.
At a glance
| Generic name | METOCLOPRAMIDE |
|---|---|
| Sponsor | Hikma |
| Drug class | Dopamine-2 Receptor Antagonist |
| Target | D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
- Chemotherapy-induced nausea and vomiting
- Diabetic gastroparesis
- Gastroesophageal reflux disease
- Gastrointestinal Radiography Adjunct
- Intubation of gastrointestinal tract
- Prevention of Post-Operative Nausea and Vomiting
Boxed warnings
- WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS
Common side effects
- Tardive dyskinesia
- Motor restlessness (akathisia)
- Neuroleptic Malignant Syndrome
- Fluid retention
- Hypotension
- Hypertension
- Supraventricular tachycardia
- Bradycardia
- Acute congestive heart failure
- Possible atrioventricular (AV) block
- Gastrointestinal disturbances
- Diarrhea
Drug interactions
- anticholinergic drugs
- narcotic analgesics
- alcohol
- sedatives
- hypnotics
- tranquilizers
- monoamine oxidase inhibitors
- digoxin
- acetaminophen
- tetracycline
- levodopa
- ethanol
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:
- Reglan CI brief — competitive landscape report
- Reglan updates RSS · CI watch RSS
- Hikma portfolio CI