Domperidone: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Domperidone

Propulsives

GB MHRACA Health Canada

Drug class: Propulsives
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 45

Overview

Domperidone is an active pharmaceutical ingredient in the Propulsives group (A03FA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	30	May 29, 2026
CA Canada	Health Canada	15	May 28, 2026

GBUnited Kingdom· MHRA

30 products

Uses

GBOfficial regulatory label· revised April 10, 2026[1]

Epzit 10 mg Orodispersible Tablets are indicated for the relief of the symptoms of nausea and vomiting. 0004

How to take

CACanada· Health Canada

15 products

Uses

CAOfficial regulatory label· revised March 22, 2025[2]

TEVA-DOMPERIDONE (domperidone maleate) is indicated for: • Symptomatic management of upper gastrointestinal motility disorders associated with chronic and subacute gastritis and diabetic gastroparesis. • Prevent gastrointestinal symptoms associated with the use of dopamine agonist antiparkinsonian agents.
3 Pediatrics). 1 Dosing Considerations).

How to take

Sources & citations

[1]MHRA (UK) · PL558630021 · revised April 10, 2026
[2]Health Canada (DPD) · 01912070 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[1]

Tabulated list of adverse reactions The safety of domperidone was evaluated in clinical trials and in postmarketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies.
All patients were at least 15 years old and received at least one dose of Epzit (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.
The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000). Where frequency can not be estimated from clinical trials data, it is recorded as "Not known".
4) Ventricular arrhythmias QTc prolongation Torsade de Pointes Sudden cardiac death Gastrointestinal disorders Dry mouth Diarrhoea Skin and subcutaneous tissue disorder Rash Pruritus Urticaria Angioedema Renal and urinary disorders Urinary retention Reproductive system and breast disorders Galactorrhoea Breast pain Breast tenderness Gynaecomastia Amenorrhoea General disorders and administration site conditions Asthenia Investigations Liver function test abnormal Blood prolactin increased *exacerbation of restless legs syndrome in patients with Parkinson's disease In 45 studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher.
This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.
Reporting of suspected adverse reactions 0004 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. ”

GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[1]

Cardiovascular effects:
Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone.
8). 8). A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors. Domperidone should be used at the lowest effective dose in adults and adolescents 12 years of age and older.
). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk. Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.
Patients should be advised to promptly report any cardiac symptoms. Use with apomorphine Domperidone is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled.
Please refer to the apomorphine SmPC. e. 6 mmol/L). The dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced. Excipients Aspartame is hydrolysed in the gastrointestinal tract when orally ingested.
One of the major hydrolysis products is phenylalanine. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Co-administration of levodopa Although no dosage adjustment of levodopa is deemed necessary, an increase of plasma levodopa concentration (max 30-40%) has been observed when domperidone was taken concomitantly with levodopa.
5.

This is not medical advice. Consult a qualified healthcare professional.

1 Dosing Considerations Important considerations: • The expected benefit of an increased dose should outweigh the potential risks. 5 Post-Market Adverse Reactions). The risk may be higher in patients older than 60 years or in patients taking a daily dose of more than 30 mg.
4 Drug-Drug Interactions). Domperidone should be used at the lowest possible dose for the shortest duration necessary. One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily dose > 30 mg.
4 Drug-Drug Interactions). Patients at a higher risk of QT interval prolongation and/or cardiac arrhythmia should be considered for cardiac assessment including Electrogastrographic (EGG) before initiation of domperidone therapy and during the treatment.
TEVA-DOMPERIDONE Page 6 of 37 • Recent post-market epidemiological studies and review of post-market safety data have shown that the risk of serious ventricular arrhythmias or sudden cardiac death may be higher in patients older than 60 years of age or in patients taking a daily dose of more than 30 mg.
4 Drug-Drug Interactions). • Domperidone should be used at the lowest possible dose for the shortest duration necessary. 2 Recommended Dose and Dosage Adjustment One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily dose > 30 mg.
(see 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX) Patient with renal impairment Since very little unchanged drug is excreted via the kidneys, it is unlikely that a single administration needs to be adjusted in patients with renal insufficiency.
However, on repeated adminstration, the dosing frequency should be reduced to once or twice daily, depending on the severity of the impairment, and the dose may need to be reduced. Generally, patients on prolonged therapy should be reviewed regularly (see 7 WARNINGS AND PRECAUTIONS, Renal).
Patients with Hepatic Impairment Domperidone maleate is contraindicated in patients with moderate to severe hepatic impairment (see 2 CONTRAINDICATIONS). Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use.
4 Administration TEVA-DOMPERIDONE Tablets are for oral administration and should be taken 15 to 30 minutes before the meals. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.
If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for the forgotten dose. TEVA-DOMPERIDONE Page 7 of 37