Domperidone-based proprietary medicinal products, intestinal motility stimulant: MOTILIUM, and their generics

Opinions on drugs - Posted on Mar 21 2016

Reason for request

Renewal of inclusion

In children, insufficient clinical benefit due to unproven efficacy

In adults, low actual benefit due to poorly established efficacy at the dosage now recommended to reduce the risk of serious cardiac adverse effects

  • Domperidone, a dopamine antagonist neuroleptic, now has Marketing Authorisation only for the relief of symptoms of nausea and vomiting in adults and children.
  • In adults, its efficacy has not been established in the indication and at the dosage in the revised Marketing Authorisation. Its use should not be considered unless prescribing an antiemetic appears indispensable and is in strict accordance with its Marketing Authorisation; in particular, the dosage should be as low as possible (< 30 mg/day), the length of treatment should be as short as possible (usually less than 1 week) and there should be no contraindications (patient's comorbidities, drug interactions).
  • In children, its therapeutic benefit has not been documented. Domperidone should no longer be used.
  •  There is a risk of serious cardiac adverse effects in adults and children. The excess risk attributable to domperidone is difficult to quantify. The probable risk factors that have been identified are the concomitant use of other medicines that also prolong the QTc interval, advanced age and hypokalaemia.



Clinical Benefit




Therapeutic use


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