Section 02 · Monograph
Metoclopramide
Reviewed Nov 2026FDA label
ReglanDopamine antagonist
- Forms
- Tab: 5, 10mg | IV/IM: 5mg/mL
- Dose
- 10mg TID PRN (adjunct/nausea)
- MOA
- D2 blockade, prokinetic
Black Box Warning
- Treatment with metoclopramide can cause tardive dyskinesia (TD), a serious and often irreversible movement disorder
- Risk of TD increases with duration of treatment and total cumulative dose
- Avoid treatment durations longer than 12 weeks except in rare cases where therapeutic benefit is judged to outweigh the risk of developing TD
- Discontinue immediately if signs or symptoms of TD appear; symptoms may worsen or become irreversible even after discontinuation
Indications
- Short-term (4–12 weeks) therapy for symptomatic gastroesophageal reflux (GERD) in adults who fail conventional therapyFDA-labeled
- Relief of symptoms associated with acute and recurrent diabetic gastroparesisFDA-labeled
- In migraine care, used off-label as an antiemetic/prokinetic adjunct to improve gastric absorption of oral abortive agents and to treat nauseaFDA-labeled
Off-Label Uses
- Adjunctive antiemetic and prokinetic agent for acute migraine attacks (IV/IM in ED settings, or oral adjunct to abortive therapy)Off-label
- Treatment of migraine-associated nausea/vomiting and gastric stasis limiting absorption of oral migraine medicationsOff-label
Mechanism of Action
- Central and peripheral dopamine D2-receptor antagonist, accounting for antiemetic effects (chemoreceptor trigger zone) and central extrapyramidal side effects
- Stimulates motility of the upper GI tract (increases lower esophageal sphincter tone, gastric/duodenal contractions) without stimulating gastric, biliary, or pancreatic secretions
- Sensitizes GI smooth muscle to the effects of acetylcholine
- In migraine, prokinetic effect helps counteract migraine-associated gastroparesis, improving absorption of co-administered oral analgesics/triptans
Full Dosing
Adult / usual
- GERD: 10–15 mg orally up to 4 times daily, 30 minutes before meals and at bedtime, for up to 12 weeks
- Diabetic gastroparesis: 10 mg orally 30 minutes before each meal and at bedtime for 2–8 weeks, as symptoms warrant
- Migraine adjunct (off-label, typical practice dosing): 10 mg IV/IM or oral as an antiemetic; administer slow IV push over ≥1–2 minutes to reduce risk of akathisia/restlessness
- Not recommended for chronic or maintenance use due to tardive dyskinesia risk
Renal
- Renal impairment: initiate at approximately half the recommended dose when creatinine clearance is <40 mL/min
Contraindications
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation (risk of increased GI motility complications)
- Pheochromocytoma or history of pheochromocytoma (risk of hypertensive crisis)
- History of tardive dyskinesia or dystonic reaction to metoclopramide
- Epilepsy or use with other drugs likely to cause extrapyramidal reactions (increased seizure frequency/severity)
- Known hypersensitivity or intolerance to metoclopramide
Drug Interactions
- Anticholinergic drugs and opioid/narcotic analgesics antagonize metoclopramide's GI motility effects
- Additive CNS depression/sedation with alcohol, sedatives, hypnotics, narcotics, and tranquilizers
- Use with MAO inhibitors may cause release of catecholamines — use cautiously
- Concurrent use with other drugs causing extrapyramidal reactions (e.g., antipsychotics) increases risk and severity of EPS/TD — avoid combination
- Alters GI absorption of other oral drugs: decreases absorption of digoxin; increases rate/extent of absorption of acetaminophen, tetracycline, levodopa, ethanol, and cyclosporine
- May require adjustment of insulin dose/timing due to altered rate of gastric emptying and food delivery to the small intestine
Adverse Effects
- CNS: restlessness, drowsiness, and fatigue (~10% at standard doses); less commonly insomnia, headache, confusion, dizziness
- Depression, including rare reports of suicidal ideation/behavior
- Extrapyramidal symptoms: acute dystonic reactions (~0.2%, more common in younger patients and at higher doses), parkinsonian symptoms, akathisia
- Tardive dyskinesia with prolonged use (see boxed warning)
- Neuroleptic malignant syndrome (rare, potentially fatal)
- Endocrine: galactorrhea, amenorrhea, gynecomastia (due to prolactin elevation)
- Cardiovascular: hypotension, hypertension, fluid retention (rare)
- GI: nausea, diarrhea, bowel disturbances
- Methemoglobinemia, particularly in neonates given excessive doses
- Hypersensitivity reactions
Monitoring Parameters
- Assess for early signs of tardive dyskinesia (e.g., involuntary rhythmic movements of tongue, face, mouth, jaw) at baseline and periodically during treatment
- Limit duration of use and reassess need for continued therapy; avoid >12 weeks of use
- Monitor for depression, mood changes, and suicidal ideation
- Monitor blood pressure, especially in patients with hypertension or pheochromocytoma risk
- Monitor for extrapyramidal symptoms, especially in children, young adults, and at higher doses
- In diabetics, monitor blood glucose and adjust insulin regimen as gastric emptying changes
- Assess renal function; adjust dose if creatinine clearance <40 mL/min
Pregnancy & Lactation
- Pregnancy: Available data have not identified a drug-associated risk of major birth defects or miscarriage; animal reproduction studies did not show fetal harm at doses well above human exposure
- Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
- Lactation: Metoclopramide is present in breast milk; caution is advised due to reports of adverse effects (e.g., irritability) in some breastfed infants
- Weigh developmental and health benefits of breastfeeding against the mother's clinical need for metoclopramide and any potential adverse effects on the breastfed infant