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.
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For patients
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
- 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
- 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
- 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
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- 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.