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Domperidone, commonly marketed as Motilium in many countries, blocks dopamine D2 and D3 receptors and primarily acts on the gastrointestinal tract to speed transit and reduce nausea. It is considered a prokinetic and an antiemetic in international practice.
Basic product facts:
- Active molecule: domperidone
- Common tablet strength used internationally: 10 mg
- Manifest signs: disorders of gastric motility, symptomatic relief of nausea and vomiting
Take note: Domperidone is not approved for routine marketing by the US The agency known as the Food and Drug Administration. Before considering usereassessment the regulatory and understanding the legal recognition status within the United States as well as the safety parameters and drug should not be given in the presence of these conditions.
Standard applications
Internationally, domperidone is prescribed for several gastrointestinal and symptom control purposes. Typical uses include:
- Improving delayed gastric emptying and treating associated symptoms such as nausea and early satiety.
- Relief of nausea and vomiting from various causes, including postoperative, central, or peripheral origins.
- Supportive use as an antiemetic during some chemotherapy or radiation regimens.
- Facilitating radiologic studies by increasing upper GI motility when required.
All signs should be confirmed and supervised by a licensed clinician. For US-specific access authorization rules see The United States legal and regulatory policy environment situation.
Dose and usage instructions
Only take domperidone under medical supervision. The medication is not routinely available in the US, so dosing there is normally part of an authorized program. The examples below reflect international practice and are provided for informational purposes only.
General administration guidance:
- Timing: Oral dose is usually taken 15 to 30 minutes before meals; a single dose at bedtime can be used if needed for nocturnal symptoms.
- Dose missed: If you forget to take one dose, take it when you think of it, unless the next dose is due soon. Do not increase the next dose beyond a single dose.
- Excipients: Many tablets contain lactose. If you have lactose intolerance or rare carbohydrate absorption disorders, consult your prescriber about an alternate possibility formulations.
Representative international dosing
- Acute nausea or vomiting:
- Adults: commonly 20 mg three or four times per day (two 10 mg tablets).
- The youth population aged 5 to 12 years: often 10 mg three or four times per day.
- Chronic dyspepsia or motility complaints:
- Adults: many regimens use 10 mg three times daily, with adjustment only under medical advice.
- Minor children aged 5 to 12 years: lower doses such as 5 mg three times daily may be used.
Do not use tablet formulations in children under 5 years or in those who weigh less than about 35 kg unless a suitable suspension and pediatric dosing are arranged. In severe renal impairment, dosing interval may need to be reduced because elimination is slower; follow specialist recommendations and analyze safety issues to take into account.
Global temporary storage helps stage tasks before final processing.
- Store at 20 to 25 degrees C (68 to 77 degrees F).
- Keep the product away from direct heat, strong light, and moisture to preserve potency.
- Store medications out of the reach of children and pets and in their original container when possible.
Safety details and reasons to avoid this medication
Prestart domperidone, patients should discuss risks and benefits with a healthcare professional. The drug should not be used in the following situations unless a clinician explicitly approves it:
Strict contraindication criteria
- Known hypersensitivity to domperidone or any ingredient in the formulation.
- Pregnancy or planned pregnancy, unless a prescriber judges that benefit outweighs risk.
- Breastfeeding for signals intended to increase milk production is not recommended; the FDA has warned against such use because of cardiac safety concerns.
- Gastrointestinal hemorrhage, obstruction, or perforation where stimulating motility would be harmful.
- Known prolactinoma or conditions where increasing prolactin is undesirable.
- Significant hepatic impairment.
- Documented QT interval prolongation, symptomatic heart disease, or uncorrected low potassium or magnesium.
Exercise caution and obtain specialist oversight if you have renal impairment, fluid retention, or are taking medicines that interact with domperidone. For the the reciprocal contact between individuals profile, see Conversational contact and responses across departments improve alignment. of medications. If cardiac risk is a concern, clinicians will commonly request baseline and follow-up ECGs and serum electrolytes.
Pregnancy and lactation: There is limited evidence about safety in pregnancy. Small amounts of domperidone reach breast milk. In the United States, professional guidance discourages use of domperidone to boost lactation because of potential serious cardiac events.
Drug communication in action vigilant monitoring
Domperidone interacts with a number of medicines which can either blunt its action or raise the risk of adverse cardiac events. Always review your full medication list with a prescriber or pharmacist.
Medications that may blunt prokinetic effects
- Anticholinergic agents such as oxybutynin, tolterodine, hyoscine, and propantheline.
- Strong opioid analgesics like morphine or codeine.
- Certain Parkinson disease anticholinergics such as trihexyphenidyl.
Drugs that increase domperidone exposure or cardiac risk
- Potent CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, erythromycin, some Protease inhibitors aimed at HIV.
- Calcium channel blockers that inhibit CYP3A4 such as verapamil and diltiazem.
- Other medicines that prolong the QT interval: many antiarrhythmics, some antipsychotic agents, and certain antibiotics including some fluoroquinolones.
This catalog is incomplete. If you are taking any of these medicines, your prescriber may avoid domperidone or institute additional cardiac continuous oversight. Related articles Safety and contraindication factors for details on ongoing monitoring.
Possible adverse events
Adverse reactions can vary in frequency and severity. Inform your clinician promptly if you experience new or concerning symptoms.
- Common to uncommon:
- Gastrointestinal complaints such as abdominal cramps and diarrhea.
- Rash or allergic reactions in sensitive individuals.
- Not as common but clinically important:
- Elevated prolactin levels, which can cause galactorrhea, breast enlargement, or menstrual disturbances.
- Reduced sexual desire or erectile dysfunction in some men.
- Extrapyramidal symptoms including tremor or involuntary movements; these typically require urgent evaluation.
Serious cardiac events: Domperidone has been linked to QT interval prolongation and rare ventricular arrhythmias, especially at higher doses, with interacting drugs, or in patients with cardiac disease. Seek immediate medical help for palpitations, fainting, dizziness, or syncope. This summary does not replace professional medical advice.
Equivalent medications and optional options
In the United States, clinicians often prefer approved medicines with known safety profiles. Some commonly considered additional choices include:
- Metoclopramide (Reglan) - an approved D2 antagonist with both central and peripheral activity. Effective for gastroparesis but limited to short courses due to risk of tardive dyskinesia.
- Ondansetron (Zofran) - a 5-HT3 receptor antagonist widely used to treat nausea and vomiting from chemo, radiation, and postoperative causes; not a motility agent.
- Prochlorperazine - a dopamine antagonist used for symptomatic control of nausea in various settings.
- Promethazine - an antihistamine with antiemetic effects, useful for motion sickness and related symptoms.
- Erythromycin - an antibiotic that stimulates motilin receptors and may be used short term as a prokinetic; tachyphylaxis and mutual interactions create opportunities for collaboration. limit long term use.
- Prucalopride - a selective 5-HT4 agonist approved for chronic constipation and sometimes used off-label for specific motility problems by specialists.
Your provider will weigh expected benefits, safety, comorbidities, and likely costs when recommending an the other option. See Prices in the United States dollars for a rough cost comparison.
Prices in the United States priced in USD
Costs depend on pharmacy, geographic location, insurance status, and whether the product is compounded under an expanded access program. The ranges below are illustrative and approximate.
- Domperidone obtained through physician-authorized compounding under an FDA IND: roughly $0.40 to $1.20 per 10 mg capsule equivalent. A 30-day supply may therefore range from about $36 to $288 depending on dose and frequency.
- Metoclopramide 10 mg strength tablets (generic): approximately $4 to $15 for a 30-tablet supply.
- Ondansetron 4 mg or 8 mg tablets (generic): about $10 to $30 for 30 tablets; brand or specialty forms cost more.
- Prochlorperazine 5 mg or tablets of a 10 mg dose (generic): roughly $4 to $12 for 30 tablets.
- Promethazine twelve and a half milligrams or each tablet contains 25 mg (generic): typically $5 to $15 for 30 tablets.
- Erythromycin for short prokinetic use: commonly $10 to $25 depending on strength and duration.
Insurance coverage, coupons, and patient assistance programs can substantially reduce out of pocket cost. Because domperidone is not commercially marketed in the US, expect additional administrative or compounding fees in expanded access programs.
The regulatory and legal framework in the United States
Key regulatory points:
- Domperidone is not approved by the US Food and Drug Administration (FDA) for any indication as well as therefore is not available as a marketed commercial product in the United States.
- Access for US patients is limited and typically requires a physician to obtain authorization via an FDA expanded access Investigational New Drug (IND) application. This process involves clinical justification, informed consent, and often baseline cardiac metric monitoring such as ECG and serum electrolytes.
- Some compounding pharmacies may prepare domperidone for named patients only when the prescriber holds the required authorization. It is not available over the counter.
- Importing domperidone from foreign suppliers for personal use is generally restricted and such shipments are subject to detention by US customs and FDA. Do not attempt to import without explicit regulatory approval.
- The FDA has issued public safety communications warning against using domperidone to stimulate breast milk production because of potentially serious cardiac adverse events.
If you believe domperidone is medically indicated, discuss the FDA expanded access IND route with a US-licensed clinician. That clinician can explain keeping track of metrics requirementsroom for potential an additional choice choices, and administrative steps. For safety prerequisites, see Safety guidelines with the addition of the set of contraportents to this treatment and Interacting drug effects.
Frequently asked inquiries
- Is Motilium available over the counter in the USA?
- No. Domperidone (Motilium) is not FDA approved in the United States and is not available OTC. Limited access may be possible through a physician-sponsored FDA expanded access IND program. See The the legal and regulatory landscape and policy framework in the United States.
- Can I order domperidone online from another country and have it shipped to the USA?
- Generally no. Personal importation is restricted and packages may be detained by US customs as well as the FDA. Speak with your prescriber about legal options as well as the IND pathway rather than attempting to self-import. See The legal and regulatory affairs framework in the United States.
- What should I do if I skip taking a dose?
- Take the i skipped one dose when you remember unless it is almost time for your next scheduled dose. Do not take two doses at once. For full guidance see Dosing schedule and directions.
- Who should not take domperidone?
- People with significant cardiac disease, known QT prolongation, severe liver impairment, or those taking strong CYP3A4 inhibitors should not take domperidone unless a specialist authorizes it. See Electrical important safety cautionary notices and situations where this treatment is not advised details below.
This page is educational and does not replace individualized medical or legal advice. Always follow the guidance of your healthcare provider and current FDA communications.
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