What is the maximum daily dose of domperidone for an adult?

Maximum Daily Dose of Domperidone for Adults

The maximum daily dose of domperidone for adults is 30 mg per day (10 mg three times daily), as doses above this threshold significantly increase the risk of sudden cardiac death and QT prolongation. 1, 2

Standard Dosing and Safety Thresholds

• The defined daily dose of domperidone is 30 mg/day, which represents the upper limit for safe use in most patients 2
• Doses above 30 mg/day are associated with a sharp increase in the odds ratio for sudden cardiac death, rising from 2.8 (at standard doses) to as high as 6.21 at higher doses 2
• The safety index for domperidone at therapeutic concentrations is only approximately 2.5, which is 12-fold below the accepted minimum safety margin for cardiovascular medications 2

Evidence from Clinical Studies

While some specialized centers have used higher doses under strict monitoring protocols, the evidence strongly favors limiting doses to 30 mg/day:

• A single-center study of 246 patients using 30-80 mg/day found that 6.1% developed clinically important QT prolongation, though none exceeded the critical threshold of >500 ms 3
• Another study using doses up to 120 mg/day in refractory gastroparesis patients found that 9.5% of patients taking 120 mg/day experienced asymptomatic meaningful QT prolongation (>450 ms in males, >470 ms in females) 4
• An older study using 40-120 mg/day showed symptom improvement but reported gynecomastia in some patients and elevated prolactin levels 5

Critical Safety Considerations

The cardiovascular risks of domperidone increase substantially with:

• Daily doses exceeding 30 mg 1, 2
• Concurrent use of other QT-prolonging medications (over 120 drugs can prolong QT interval) 1
• Pre-existing cardiac conditions, electrolyte disturbances, or prolonged baseline QTc 4
• Female sex and advanced age, which increase susceptibility to QT prolongation 3

Contraindications to Higher Doses

Domperidone should not exceed 30 mg/day in patients with:

• History of dangerous arrhythmias or prolonged QTc at baseline 4
• Clinically significant electrolyte disturbances (hypokalemia, hypomagnesemia) 4
• Concurrent use of medications that prolong QT interval 1
• Cardiac disease or risk factors for sudden cardiac death 2

Monitoring Requirements if Higher Doses Are Considered

If doses above 30 mg/day are contemplated in exceptional circumstances (such as refractory gastroparesis unresponsive to all other therapies), the following monitoring is mandatory:

• Baseline ECG with QTc measurement before initiation 4, 3
• Repeat ECG at 2-6 months, 6-12 months, and annually thereafter 3
• Immediate discontinuation if QTc exceeds 450 ms (males) or 470 ms (females) 4
• Verification of normal electrolytes (potassium, magnesium, calcium) before and during therapy 4
• Review of all concurrent medications for QT-prolonging potential 1

Clinical Context and Alternatives

The gastrointestinal benefits of domperidone at the standard 30 mg/day dose fail to show unequivocal benefits beyond placebo effect, while consistently demonstrating increased risk of sudden cardiac death across five population-based studies. 2

Given this unfavorable risk-benefit profile, domperidone should be reserved for patients who have failed other antiemetic therapies, and the dose should not exceed 30 mg/day in routine clinical practice. Higher doses (up to 80-120 mg/day) have been used in highly selected patients at specialized centers with intensive cardiac monitoring, but this approach carries substantial cardiovascular risk and should only be considered when all other treatment options have been exhausted. 4, 3