Evigrade

Metoclopramide

AEMPS

Prokinetic, dopamine D2 receptor antagonist

ATC code: A03FA01

Brand names: Reglan, Maxolon

Updated · Methodology

Indications

B

Chemotherapy-induced nausea and vomiting

Second line

Controls delayed nausea and vomiting after moderately emetogenic chemotherapy when 5-HT3 antagonists fail. SEOM positions metoclopramide as a supportive option.

ICD-10: R11.0 · ICD-11: MD90

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Blocks central and peripheral D2 receptors and adds 5HT4 stimulation in the upper GI tract – accelerates gastric emptying and suppresses nausea. limited courses to 5 days and the daily dose to 30 mg in 2013 due to neurological adverse effects. boxed warning: tardive dyskinesia develops with use beyond 12 weeks, especially in the elderly and in women.

Safety

Contraindications

  • Hypersensitivity to metoclopramide
  • Gastrointestinal haemorrhage, perforation or mechanical obstruction
  • Phaeochromocytoma
  • Parkinson disease
  • Epilepsy

Serious adverse effects

  • Tardive dyskinesia with prolonged use
  • Neuroleptic malignant syndrome
  • QT prolongation and ventricular arrhythmias
  • Methaemoglobinaemia (particularly in neonates)

Common adverse effects

  • Somnolence, fatigue
  • Diarrhoea
  • Asthenia
  • Extrapyramidal reactions (more frequent in children and young adults)

Pregnancy: can you take Metoclopramide?

AEMPS summary of product characteristics (section 4.6): a large amount of data in pregnant women (more than 1,000 exposed pregnancies) indicates no malformations or fetal toxicity. Metoclopramide can be used in pregnancy when clinically needed. Because of its pharmacological properties, as with other neuroleptics, extrapyramidal syndrome in the newborn cannot be excluded after use at the end of pregnancy, so use at the end of pregnancy is avoided. If metoclopramide is used, the newborn is monitored.

Breastfeeding: can you take Metoclopramide?

Compatible for short courses. Hale L2. Transfers into milk (RID about 4–5%) without clinical problems observed in infants. The 2014 AEMPS restriction limiting treatment to 5 days due to extrapyramidal effects in adults also applies to breastfeeding mothers.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions46 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Moderateantihistamínicosclass named in the label
    «Anticolinérgicos y derivados de la morfina: Depresores de SNC (derivados de la morfina, ansiolíticos, antihistamínicos H 1 sedantes, antidepresivos sedantes, barbitúricos, clonidina y relacionados)»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantipsicóticosclass named in the label
    «Neurolépticos: La metoclopramida puede tener un efecto aditivo con otros neurolépticos en la aparición de trastornos extrapiramidales.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebarbitúricosclass named in the label
    «Anticolinérgicos y derivados de la morfina: Depresores de SNC (derivados de la morfina, ansiolíticos, antihistamínicos H 1 sedantes, antidepresivos sedantes, barbitúricos, clonidina y relacionados)»

    AEMPS, section 4.5 · Open on CIMA

  • «Rifampicina: En un estudio publicado realizado en 12 voluntarios sanos, la administración de 600 mg de rifampicina durante 6 días, disminuyó la exposición plasmática de metoclopramida (AUC-Área bajo…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiclosporin
    «Ciclosporina: La metoclopramida aumenta la biodisponibilidad de la ciclosporina (Cmax en un 46% y exposición en un 22%). Se requiere una monitorización cuidadosa de las concentraciones plasmáticas de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateClonidine
    «Anticolinérgicos y derivados de la morfina: Depresores de SNC (derivados de la morfina, ansiolíticos, antihistamínicos H 1 sedantes, antidepresivos sedantes, barbitúricos, clonidina y relacionados)»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatedepresores del SNCclass named in the label
    «Anticolinérgicos y derivados de la morfina: Depresores de SNC (derivados de la morfina, ansiolíticos, antihistamínicos H 1 sedantes, antidepresivos sedantes, barbitúricos, clonidina y relacionados)»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDigoxin
    «Digoxina: La metoclopramida puede reducir la biodisponibilidad de la digoxina. Se requiere una monitorización cuidadosa de las concentraciones plasmáticas de digoxina.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateISRSclass named in the label
    «Medicamentos serotoninérgicos: El uso de metoclopramida con medicamentos serotoninérgicos tales como ISRS puede aumentar el riesgo del síndrome serotoninérgico.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatemedicamentos serotoninérgicosclass named in the label
    «Medicamentos serotoninérgicos: El uso de metoclopramida con medicamentos serotoninérgicos tales como ISRS puede aumentar el riesgo del síndrome serotoninérgico.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateMorphine
    «Anticolinérgicos y derivados de la morfina: Los anticolinérgicos y los derivados de la morfina poseen un antagonismo mutuo con metoclopramida en la motilidad del tracto digestivo.»

    AEMPS, section 4.5 · Open on CIMA

  • «Rifampicina: En un estudio publicado realizado en 12 voluntarios sanos, la administración de 600 mg de rifampicina durante 6 días, disminuyó la exposición plasmática de metoclopramida (AUC-Área bajo…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «Rifampicina: En un estudio publicado realizado en 12 voluntarios sanos, la administración de 600 mg de rifampicina durante 6 días, disminuyó la exposición plasmática de metoclopramida (AUC-Área bajo…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «Rifampicina: En un estudio publicado realizado en 12 voluntarios sanos, la administración de 600 mg de rifampicina durante 6 días, disminuyó la exposición plasmática de metoclopramida (AUC-Área bajo…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibidores fuertes del CYP2D6: Se incrementan los niveles de exposición de metoclopramida cuando se administra conjuntamente con inhibidores fuertes del CYP2D6 tales como fluoxetina y paroxetina…»

    AEMPS, section 4.5 · Open on CIMA

  • Minorinhibidores del CYP2D6class named in the label
    «Inhibidores fuertes del CYP2D6: Se incrementan los niveles de exposición de metoclopramida cuando se administra conjuntamente con inhibidores fuertes del CYP2D6 tales como fluoxetina y paroxetina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibidores fuertes del CYP2D6: Se incrementan los niveles de exposición de metoclopramida cuando se administra conjuntamente con inhibidores fuertes del CYP2D6 tales como fluoxetina y paroxetina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Drug Interactions: Absorption of drugs from the stomach may be diminished (e.g. digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased…»

    FDA, section 7 · Open on DailyMed

  • «Drug Interactions: Absorption of drugs from the stomach may be diminished (e.g. digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased…»

    FDA, section 7 · Open on DailyMed

  • insulinclass named in the label
    «Drug Interactions: Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and…»

    FDA, section 7 · Open on DailyMed

  • MAO inhibitorsclass named in the label
    «Drug Interactions: The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving…»

    FDA, section 7 · Open on DailyMed

From other drugs’ labels

  • «DRUG INTERACTIONS: CABERGOLINE, a dopamine receptor agonist, is not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.»

    FDA, section 7 · Open on DailyMed

  • «Metoclopramida: Se ha mostrado que la administración concomitante de metoclopramida reduce las concentraciones en suero y orina de fosfomicina y, por tanto, se debe evitar.»

    AEMPS, section 4.5 · Open on CIMA

  • «Los neurolépticos y otros antagonistas dopaminérgicos con actividad a nivel central, como sulpirida o metoclopramida, pueden disminuir la eficacia de ropinirol y, por tanto, debe evitarse el uso…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDigoxin
    «Pharmacokinetic Drug Interactions: Acarbose, activated charcoal, albuterol, antacids, certain cancer chemotherapy or radiation therapy, cholestyramine, colestipol, exenatide, kaolin-pectin, meals…»

    FDA, section 7 · Open on DailyMed

  • ModerateRopinirole
    «DRUG INTERACTIONS: Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole may be required. (7.1, 12.3) Hormone replacement therapy (HRT): Starting or…»

    FDA, section 7 · Open on DailyMed

  • ModerateTacrolimus
    «Effects of Other Drugs on Tacrolimus: Other drugs, such as: Magnesium and aluminum hydroxide antacids Metoclopramide May increase tacrolimus whole blood trough concentrations and increase the risk of…»

    FDA, section 7 · Open on DailyMed

  • «Clinically-Significant Drug Interactions: Metoclopramide Use with caution HR/SS»

    FDA, section 7 · Open on DailyMed

  • «Combinaciones que requieren una consideración específica: El uso combinado de carbamazepina y litio o metoclopramida, por un lado y de carbamazepina y neurolépticos (haloperidol, tioridazina), por…»

    AEMPS, section 4.5 · Open on CIMA

  • «Fármacos que aumentan los niveles de ciclosporina: Es de esperar que todos los inhibidores del CYP3A4 y/o gp-P aumenten los niveles de ciclosporina. Ejemplos son: nicardipino, metoclopramida…»

    AEMPS, section 4.5 · Open on CIMA

  • «Metoclopramida: Metoclopramida acelera la absorción de ciprofloxacino (oral), resultando en un tiempo más corto para alcanzar las concentraciones plasmáticas máximas. No se observó ningún efecto en…»

    AEMPS, section 4.5 · Open on CIMA

  • «La metoclopramida administrada por vía intravenosa (pero no la administrada por vía oral) aumenta la tasa de absorción de diazepam e incrementa la concentración máxima que se consigue tras la…»

    AEMPS, section 4.5 · Open on CIMA

  • «antiácidos, algunos laxantes, caolin-pectina, neomicina, penicilamina, rifampicina, algunos citostáticos, metoclopramida, sulfasalazina, adrenalina, salbutamol, colestiramina, fenitoína.»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacciones farmacológicas: Fesoterodina puede reducir el efecto de medicamentos que estimulan la motilidad del tracto gastrointestinal, como metoclopramida.»

    AEMPS, section 4.5 · Open on CIMA

  • «Drug Interactions: Metoclopramide: When coadministered with fosfomycin tromethamine, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary…»

    FDA, section 7 · Open on DailyMed

  • «Estimulantes de la motilidad: petidina tiene un efecto antagónico sobre metoclopramida y domperidona.»

    AEMPS, section 4.5 · Open on CIMA

  • «Dopamine Antagonists: Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide…»

    FDA, section 7 · Open on DailyMed

  • «Puede reducirse el efecto de procinéticos como la metoclopramida.»

    AEMPS, section 4.5 · Open on CIMA

  • «Dopaminergic Antagonists: It is possible that dopamine antagonists, such as antipsychotics or metoclopramide, could diminish the effectiveness of rasagiline.»

    FDA, section 7 · Open on DailyMed

  • «Pueden observarse interacciones farmacocinéticas con agentes procinéticos gastrointestinales, como cisaprida y metoclopramida.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Metoclopramide used for?

Metoclopramide is evaluated for the following indications with varying evidence strength: Chemotherapy-induced nausea and vomiting (evidence tier B), Nausea and vomiting of pregnancy (evidence tier B), Postoperative nausea and vomiting (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Metoclopramide?

Common side effects of Metoclopramide (≥ 1 in 100): Somnolence, fatigue, Diarrhoea, Asthenia, Extrapyramidal reactions (more frequent in children and young adults). See the Safety section for uncommon and serious reactions.

Is Metoclopramide safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): a large amount of data in pregnant women (more than 1,000 exposed pregnancies) indicates no malformations or fetal toxicity. Metoclopramide can be used in pregnancy when clinically needed. Because of its pharmacological properties, as with other neuroleptics, extrapyramidal syndrome in the newborn cannot be excluded after use at the end of pregnancy, so use at the end of pregnancy is avoided. If metoclopramide is used, the newborn is monitored.

Is Metoclopramide compatible with breastfeeding?

Compatible for short courses. Hale L2. Transfers into milk (RID about 4–5%) without clinical problems observed in infants. The 2014 AEMPS restriction limiting treatment to 5 days due to extrapyramidal effects in adults also applies to breastfeeding mothers.

Who should not take Metoclopramide?

Metoclopramide is contraindicated in: Hypersensitivity to metoclopramide; Gastrointestinal haemorrhage, perforation or mechanical obstruction; Phaeochromocytoma; Parkinson disease; Epilepsy. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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