Metoclopramide

ATC code

A03FA01

Therapeutic class

Prokinetic agent · Prokinetic

Forms

oral tablet, oral solution, injectable solution

Brand names

Metoclopramida Accord (ES) · Reglan (US) · Primpéran (FR)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA Ficha Técnica: 75665
https://cima.aemps.es/cima/dochtml/ft/75665/FT_75665.html
PubMed PMID:42259699 ↗
CredibleMeds.org
Flockhart Table (Indiana University)
Professional clinical knowledge
AEMPS CIMA · nº registro 75665 ↗
RxNorm rxcui 6915 ↗

Approved indications

Adults: Prevention of postoperative nausea and vomiting (PONV), symptomatic treatment of nausea and vomiting (including that induced by acute migraine), prevention of delayed chemotherapy-induced nausea and vomiting (CINV) and radiotherapy-induced nausea and vomiting (RINV).
Pediatric population (1-18 years): Second-line option for the prevention of delayed CINV and for the treatment of established PONV.
Improvement of gastroduodenal visualization during endoscopy in acute upper gastrointestinal bleeding. · investigational

Contraindications

Absolute

Hypersensitivity to the active substance. Gastrointestinal hemorrhage, obstruction, or perforation. Pheochromocytoma. History of tardive dyskinesia. Epilepsy. Parkinson's disease. Combination with levodopa or dopaminergic agonists. History of methemoglobinemia. Children under 1 year of age.

Clinical warnings

Boxed warning · Risk of Tardive Dyskinesia: Chronic treatment can cause tardive dyskinesia, a potentially irreversible movement disorder. The risk increases with treatment duration and total cumulative dose. Treatment should not exceed 3 months (5 days in most European jurisdictions). — FDA
Major warning · Neurological disorders: Extrapyramidal symptoms may occur, especially in children and young adults, and/or with high doses. Limiting treatment duration to 5 days is recommended to minimize risk. — AEMPS CIMA

Drug interactions

HighLevodopaN04BA01
Mechanism: Mutual antagonism between dopaminergic agonists/levodopa and metoclopramide (a dopamine antagonist).
Recommendation: Contraindicated. Concomitant use is forbidden.
AEMPS CIMA
ModerateFluoxetineN06AB03
Mechanism: Fluoxetine is a strong CYP2D6 inhibitor, the main metabolizing enzyme for metoclopramide. Co-administration increases metoclopramide exposure, raising the risk of adverse effects, especially extrapyramidal symptoms.
Recommendation: Monitor the patient for adverse reactions. Consider a dose reduction of metoclopramide.
AEMPS CIMA

Adverse events

Common (≥1%)

somnolence · asthenia · extrapyramidal disorders · parkinsonism · akathisia · depression · hypotension

Rare but serious

tardive dyskinesia · neuroleptic malignant syndrome · convulsions · methemoglobinemia · bradycardia · cardiac arrest

Pregnancy and lactation

Pregnancy: A large amount of data on pregnant women indicates no malformative or foetotoxic toxicity. May be used during pregnancy if clinically necessary. Lactation: Excreted in human milk; adverse effects in the breast-fed infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.

Recent literature (PubMed)

High-dose metoclopramide versus placebo for gastroduodenal visualization during endoscopy in patients with acute upper gastrointestinal bleeding. A triple-blind, randomized clinical trial.
Herrera-Elizondo JL, et al. · Rev Gastroenterol Mex (Engl Ed) · 2026 · Relevance 4/5
Un ensayo clínico aleatorizado, triple ciego, evaluó la utilidad de 20 mg IV de metoclopramida para mejorar la visualización endoscópica en hemorragia digestiva alta. El estudio incluyó 50 pacientes y no encontró diferencias estadísticamente significativas en la visualización (puntuación de Avgerinos), la necesidad de una nueva endoscopia o la duración de la estancia hospitalaria en comparación con el placebo. La conclusión es que la metoclopramida no mejoró los resultados en este contexto.