domperidone

Last edited 01/2021 and last reviewed 01/2021

Cautions: renal impairment, pregnancy, breast-feeding; not for chronic administration.

Side-effects: raised prolactin (possible galactorrhoea and gynaecomastia), reduced libido; rashes and other allergic reactions; acute dystonic reaction.

• domperidone is also associated with a small increased risk of serious cardiac side effects
  • its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced
  • should no longer be used for the treatment of bloating and heartburn
  • domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors (see below). Patients with these conditions and patients receiving long-term treatment with domperidone should be reassessed at a routine appointment, in light of the new advice

Advice for Health Professionals following acknowledgement of increased risk of cardiac effects (2):

• Indication
  • Domperidone is now restricted to use in the relief of nausea and vomiting
  • It should be used at the lowest effective dose for the shortest possible time
    
    
• Contraindications
  • Domperidone is now contraindicated in people:
    • with conditions where cardiac conduction is, or could be, impaired
    • with underlying cardiac diseases such as congestive heart failure
    • receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors
    • with severe hepatic impairment
      
      
• Duration of treatment
  • the maximum treatment duration should not usually exceed one week
  • patients currently receiving long-term treatment with domperidone should be reassessed at a routine appointment to advise on treatment continuation, dose change, or cessation

Patients with these conditions should have their treatment reviewed at their next routine appointment and be switched to an alternative treatment if required

Check the summary of product characteristcs before prescribing this drug.

Notes:

• QT prolongation leading to cardiac arrhythmias, including life-threatening torsades de pointes, has also been attributed to oral domperidone. In 2010, two case-control studies, one Canadian and one Dutch, showed that patients who died suddenly or had severe ventricular arrhythmias were statistically significantly more likely than controls to have been exposed to domperidone (3)
• a systematic review and meta-analysis of observational studies was undertaken and concluded that domperidone is associated with an increased risk of sudden cardiac death and ventricular arrhythmia compared to non-use (4)

Reference:

• Prescribers' Journal (1999), 39 (3), 166-172.
• MHRA (May 2015).Domperidone: risk of cardiac side effects - restricted indication, new contraindications, and reduced dose and duration of use
• Prescrire Int. 2012 Jul;21(129):183.
• Ou LB et al. Domperidone and the Risks of Sudden Cardiac Death and Ventricular Arrhythmia: A Systematic Review and Meta-Analysis of Observational Studies.Br J Clin Pharmacol. 2021. Accepted Author Manuscript.