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Dopamine D2 Antagonist (Peripheral) — Nausea / GORD / Gastroparesis in Children Pregnancy: 'There are limited post-marketing data on the use of domperidone in pregnant women. Studies in animals have shown reproductive toxicity at maternally toxic doses. Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.' Breast-feeding: domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose; adverse effects, in particular cardiac effects, cannot be excluded — a decision should be made whether to discontinue breast-feeding or domperidone, and caution should be exercised in case of QTc prolongation risk factors in breast-fed infants (§4.6).

Domperidone (Paediatric)

Brand names: Motilium

Domperidone is a peripheral dopamine antagonist with antiemetic and prokinetic actions, used in children with caution for nausea and vomiting; its role is now restricted because of cardiac safety concerns.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Adults and adolescents 12 years of age and older and weighing 35 kg or more: 10 ml of oral suspension containing domperidone 1 mg per ml (i.e. 10 mg) up to three times per day
Route: Oral — 'It is recommended to take oral domperidone 15-30 minutes before meals. If taken after meals, absorption of the drug is somewhat delayed'
Frequency: Up to three times per day
Max: 'a maximum daily dose of 30 ml per day' (i.e. 30 mg per day). 'Usually, the maximum treatment duration should not exceed one week'
SOURCE: eMC UK SPC, productName 'Domperidone 1mg/ml Oral Suspension', §4.2. 'Domperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.' If a scheduled dose is missed, omit it and resume the usual dosing schedule — the dose should not be doubled to make up for a missed dose. PAEDIATRIC — VERBATIM §4.2: 'The efficacy of domperidone in children less than 12 years of age has not been established. The efficacy of domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been established.' This SPC therefore provides NO dose for children under 12 years or for adolescents under 35 kg, which is why paedDose is null — do not extrapolate a paediatric dose from the adult regimen; source paediatric use from a children's formulary. CARDIAC RISK (§4.4): domperidone has been associated with QT prolongation and torsades de pointes; epidemiological studies showed an increased risk of serious ventricular arrhythmias or sudden cardiac death, with higher risk in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors. Stop treatment if signs or symptoms of cardiac arrhythmia occur. HEPATIC IMPAIRMENT: contraindicated in moderate (Child-Pugh 7 to 9) or severe (Child-Pugh above 9) hepatic impairment; no dose modification needed in mild (Child-Pugh 5 to 6) impairment. EXCIPIENTS: each 5 ml contains 2.275 g sorbitol (E420) — patients with hereditary fructose intolerance should not take it; also contains propylhydroxybenzoate (E216) and methylhydroxybenzoate (E218). Source §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved.

Dose adjustments

Renal

'Since the elimination half-life of domperidone is prolonged in severe renal impairment (serum creatinine > 6mg/100mL, i.e. 0.6 mmol/L), the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients with severe renal impairment should be reviewed regularly' (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to domperidone or any of the excipients
  • Prolactin-releasing pituitary tumour (prolactinoma)
  • Confirmed or suspected phaeochromocytoma, due to the risk of severe hypertension episodes
  • When stimulation of gastric motility could be harmful, e.g. gastro-intestinal haemorrhage, mechanical obstruction or perforation
  • Moderate or severe hepatic impairment
  • Known existing prolongation of cardiac conduction intervals, particularly QTc, significant electrolyte disturbances, or underlying cardiac disease such as congestive heart failure
  • Co-administration with QT-prolonging drugs, with the exception of apomorphine
  • Co-administration with potent CYP3A4 inhibitors, regardless of their QT-prolonging effects

Side effects

  • Dry mouth (common); diarrhoea (uncommon)
  • QTc prolongation, torsade de pointes, ventricular arrhythmias and sudden cardiac death (frequency not known; see §4.4)
  • Somnolence and headache (uncommon); extrapyramidal disorder, convulsion, oculogyric crisis and restless legs syndrome exacerbation (uncommon/not known)
  • Raised blood prolactin, galactorrhoea, gynaecomastia, breast pain, breast tenderness and amenorrhoea
  • Rash, pruritus, urticaria and angioedema; anaphylactic reaction including anaphylactic shock; urinary retention; abnormal liver function test

Interactions

  • QT-prolonging medicinal products — co-administration is contraindicated, with the exception of apomorphine, for which co-administration is only acceptable if the benefit outweighs the risks and the precautions in the apomorphine SmPC are strictly fulfilled (§4.3, §4.4)
  • Potent CYP3A4 inhibitors — co-administration is contraindicated regardless of their QT-prolonging effect (§4.3)
  • Concurrent QT-prolonging drugs or CYP3A4 inhibitors — associated with a higher risk of serious ventricular arrhythmias or sudden cardiac death, alongside age over 60 years and daily doses greater than 30 mg (§4.4)
  • Conditions increasing proarrhythmic risk — electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) and bradycardia (§4.4)
  • NOTE: the UK SPC §4.5 interaction section was NOT retrieved in this source bundle — the clinician must verify the full interaction list before publishing

Clinical monograph

How it works

It blocks dopamine D2 receptors in the chemoreceptor trigger zone and upper gut, reducing nausea and enhancing gastric emptying, while largely not crossing the blood-brain barrier.

Prescribing in practice

  • Domperidone can prolong the QT interval and cause serious ventricular arrhythmias, so it is contraindicated in cardiac conduction disorders, significant electrolyte disturbance and with other QT-prolonging or interacting drugs, and should be used at the lowest effective dose for the shortest time.
  • It is contraindicated in moderate to severe hepatic impairment and where prokinetic action could be harmful, such as gastrointestinal obstruction or bleeding.
  • Use only when other measures are inappropriate, dosing by body weight with a children's formulary.

Monitoring

Assess cardiac risk before starting, correct electrolytes, and review the ongoing need regularly given the QT prolongation risk.

Counselling the patient

  • Stop the medicine and seek help if palpitations, fainting or an irregular heartbeat occur.
  • Use it only for as long as advised and avoid combining with other medicines unless checked.
  • Tell the team about any heart problems or family history of sudden cardiac death.

Evidence & guidelines

An MHRA review led to restricted indications and reinforced contraindications for domperidone owing to a small increased risk of serious cardiac side effects.

Reference: MHRA Drug Safety Update 2014 (Domperidone QT Risk); NICE CG184 (GORD in Infants); ESPGHAN GORD Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.