() is a dopamine antagonist with pro-kinetic, and antiemetic properties. This drug product may be dispensed either by its classification, prescription or Over-the-Counter (OTC) drug. OTC drug products are accessible to the general public as these drugs are sold without physician’s prescription. The FDA conducted a literature review to assess the safety of Domperidone considering regulatory actions made by other countries in response to an epidemiological study showing that this drug is associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. 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 (e.g. disopyramide, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, haloperidol, pimozide, sertindole, citalopram, escitalopram) or CYP3A4 inhibitors (e.g. clarithromycin, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telithromycin, telaprevir and voriconazole).