Metoclopramide

Ceolat, Metoclopramidhydrochlorid Accord, Metoclopramidhydrochlorid Noridem, Paspertin · ATC code A03FA01

Also known as: Metoclopramid, metoklopramid · Brand names: Ceolat, Metoclopramidhydrochlorid Accord, Metoclopramidhydrochlorid Noridem, Paspertin, Mcp, Metoclopramidhydrochlorid Basi, Metoclopramidhydrochlorid Ipca, Anti-Nausea, Emoject, Metoplon, Metoprax, Metpamid, Nastifran, Pramed, Primperan …

Key facts
Active substance
Metoclopramide
Drug class
Prokinetic agent
ATC code
A03FA01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

  • • Metoclopramide, including metoclopramide tablets, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including metoclopramide tablets, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1)].
  • • Metoclopramide tablets are contraindicated in patients with a history of TD.
  • • Use metoclopramide tablets for the shortest duration of treatment and periodically reassess the need for continued treatment.
  • • Immediately discontinue metoclopramide tablets in patients who develop signs or symptoms of TD [see Warnings and Precautions (5.1)].
  • • In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of metoclopramide tablets treatment is 12 weeks [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
  • • In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including metoclopramide tablets, for longer than 12 weeks. If longer term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions (5.1)].

Key facts

Metoclopramide is a dopamine antagonist with prokinetic action. The tablets are used in adults with gastroesophageal reflux not responding to conventional therapy and in diabetic gastroparesis.

What it is used for

  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail conventional therapy
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis
  • Not recommended in pediatric patients (risk of TD, other extrapyramidal symptoms and methemoglobinemia in neonates)

Dosing

  • Reflux: 10 to 15 mg four times daily, thirty minutes before each meal and at bedtime; maximum 60 mg/day; maximum 12 weeks
  • Reflux, intermittent: single dose up to 20 mg before the provoking situation
  • Diabetic gastroparesis: 10 mg four times daily, maximum 40 mg/day; avoid treatment longer than 12 weeks
  • Dose reductions for elderly patients, hepatic or renal impairment, CYP2D6 poor metabolizers and strong CYP2D6 inhibitors; details in the full prescribing information

Contraindications

  • History of tardive dyskinesia or dystonic reaction to metoclopramide
  • When stimulation of GI motility might be dangerous (hemorrhage, mechanical obstruction, perforation)
  • Pheochromocytoma or other catecholamine-releasing paragangliomas
  • Epilepsy
  • Hypersensitivity to metoclopramide

Important warnings

  • Boxed warning: tardive dyskinesia, potentially irreversible; risk increases with duration and cumulative dose; discontinue immediately if signs develop
  • TD risk higher in the elderly, especially elderly women, and in diabetes mellitus
  • Other extrapyramidal symptoms, neuroleptic malignant syndrome
  • Depression, hypertension, fluid retention, hyperprolactinemia; impaired ability to drive

Side effects

  • Most common (in approximately 10% at 10 mg four times daily): restlessness, drowsiness, fatigue, lassitude
  • After stopping: dizziness, nervousness, headaches
  • Serious: tardive dyskinesia, neuroleptic malignant syndrome, depression

Interactions

  • Antipsychotics: additive effects (TD, EPS, NMS); avoid concomitant use
  • Strong CYP2D6 inhibitors (e.g. quinidine, bupropion, fluoxetine, paroxetine): reduce metoclopramide dosage
  • MAO inhibitors: increased risk of hypertension; avoid concomitant use

Pregnancy and breastfeeding

  • Published studies do not report increased risk of adverse pregnancy outcomes; potential risks to the neonate after exposure during delivery

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • CeolatG.L. Pharma Gmbh · 2 register entries
  • Metoclopramidhydrochlorid AccordAccord Healthcare B.V. · 2 register entries
  • Metoclopramidhydrochlorid NoridemNoridem Enterprises Ltd · 1 register entry
  • PaspertinViatris Austria Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • CeolatG.L. Pharma Gmbh · 1 register entry
  • McpAbz-Pharma Gmbh, Aliud Pharma Gmbh, Stadapharm Gmbh, Hexal Ag, Ratiopharm Gmbh · 9 register entries
  • Metoclopramidhydrochlorid BasiLaboratórios Basi – Indústria Farmacêutica, S.A. · 2 register entries
  • Metoclopramidhydrochlorid IpcaIpca Productos Farmaceuticos Unipessoal Lda · 1 register entry
  • Metoclopramidhydrochlorid NoridemNoridem Enterprises Ltd · 2 register entries
  • PaspertinViatris Healthcare Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • Anti-NauseaONFARMA İLAÇ SAN. LTD. ŞTİ. · 2 register entries
  • EmojectTÜM-EKİP İLAÇ A.Ş. · 1 register entry
  • MetoplonRDC İLAÇ ARAŞTIRMA VE GELİŞTİRME SAN. A.Ş. · 1 register entry
  • MetopraxAY PHARMACY İLAÇ TİC. A.Ş. · 1 register entry
  • MetpamidSİFAR İLAÇLARI TİC. VE SAN. A.Ş. · 3 register entries
  • NastifranMENTA PHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PramedHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • PrimperanBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • PrimselOSEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Turktipsan Metoklopramid HidroklorürTURKTIPSAN SAĞLIK TURİZM EĞİTİM VE TİC. A.Ş. · 1 register entry
  • VomepramVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • GimotiEvoke Pharma, Inc. · 1 register entry
  • ReglanANI Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 26 more European countries
Bulgaria
Klometol, Антиеметин, Деган, Елитан, Метоклопрамид Ромфарм, Метоклопрамидe Xамелн, Реглан, Церукал
Croatia
Metoklopramidklorid Hameln, Metopran, Reglan
Cyprus
Cloperan, Elitan, Metoclopramide Accord, Pribekinet, Veriligo
Czechia
Cerucal, Degan, Metoclopramide Hameln, Metoclopramide Noridem
Denmark
Metoclopramide Accord, Metoclopramide G.L. Pharma, Metoclopramide Noridem, Metoclopramide Orifarm, Metoclopramide Orion, Metoclopramide “medical Valley”, Primperan
Estonia
Cerucal, Metoclopramide Accord, Metoclopramide Basi
Finland
Metoclopramide Accord, Metoclopramide Baxter, Metoclopramide G.L. Pharma, Metoclopramide Noridem, Metoclopramide Orion, Primperan
France
Chlorhydrate De Metoclopramide Renaudin, Metoclopramide Noridem, Metoclopramide Sandoz, Metoclopramide Viatris, Primperan, Prokinyl L.P.
Greece
Pribekinet, Primperan, Vergomet, Veriligo
Hungary
Cerucal, Klometol, Metoclopramide S.A.L.F., Metoklopramid Hameln, Metoklopramid-Hidroklorid Noridem
Iceland
Afipran
Ireland
Maxolon, Metoclopramide Hydrochloride Accord Healthcare Ireland, Metoclopramide Hydrochloride Noridem Enterprises, Metoclopramide Mercury Pharmaceuticals (Ireland)
Italy
Maalox Nausea Adulti, Metoclopramide Accord, Metoclopramide Cloridrato Noridem, Metoclopramide S.A.L.F., Plasil
Latvia
Cerucal, Metoclopramid Basi, Metoclopramid Polpharma
Lithuania
Cerucal, Elitan, Metoclopramid Polpharma, Metoclopramide Basi
Luxembourg
Mcp, Prokinyl L.P.
Malta
Elitan, Metoclopramide
Netherlands
Metoclopramide Hcl Basi, Metoclopramide Hcl Cf, Metoclopramide Hcl Noridem, Metoclopramide Hcl Teva, Metoclopramidemonohydrochloride Accord, Primperan
Norway
Afipran, Metoclopramide Accord, Metoclopramide G.L. Pharma, Metoclopramide Medical Valley, Metoclopramide Noridem, Metoclopramide Orifarm
Poland
Metoclopramide Hameln, Metoclopramidi Hydrochloridum Noridem, Metoclopramidum Polpharma, Olamide
Portugal
Metgen, Metoclopramida Basi, Metoclopramida Ipca, Metoclopramida Labesfal, Metoclopramida Medinfar, Metoclopramida Medlink, Metoclopramide Noridem, Primperan
Romania
Metoclopramid Arena, Metoclopramid Biofarm, Metoclopramid Hameln, Metoclopramid Laropharm, Metoclopramid Slavia, Metoclopramid Terapia, Metoclopramide Hydrochloride Anhydrous Noridem
Slovakia
Degan, Metoclopramide Hameln, Metoclopramide Noridem
Slovenia
Metoklopramid Hameln, Reglan
Spain
Metoclopramida Accord, Metoclopramida Basi, Metoclopramida Kern Pharma, Metoclopramida Noridem, Metoclopramida Pensa, Primperan
Sweden
Metoclopramide Accord, Metoclopramide Baxter, Metoclopramide G.L. Pharma, Metoclopramide Medical Valley, Metoclopramide Noridem, Metoclopramide Orion

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. U.S. Food and Drug Administration. Metoclopramide (ANI Pharmaceuticals, Inc.) – Prescribing Information, 2026-05-18. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=797aad80-0597-42f8-99d5-39de180c3b5a
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC A03FA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.