Benzamide prokinetic with combined serotonin and dopamine receptor activity
ATC code: A03FA06 (Cinitapride)
A D2 dopamine and 5-HT2 serotonin receptor antagonist with concurrent 5-HT1 and 5-HT4 agonism. Enhances acetylcholine release in the myenteric plexus of the small intestine, accelerating gastric emptying and small-bowel motility. Clinical data are limited compared with metoclopramide and domperidone – most trials were carried out in Spain and Latin America.
Second line
In functional dyspepsia, cinitapride is used symptomatically when postprandial distress predominates. Evidence is modest: Spanish and Latin American trials showed symptom reduction versus placebo, but large independent meta-analyses are absent. International guidelines (Rome IV, 2022) do not list it as a preferred agent – first-line is a PPI and Helicobacter pylori eradication.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Prokinetics are not first-line in GERD. Cinitapride may be added to a proton-pump inhibitor for persistent motility-related symptoms (belching, postprandial nausea), but the benefit is limited and does not exceed PPI dose optimization.
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Contraindicated in pregnancy due to limited data and potential fetal neurological risk.
No data on milk excretion. Use in lactation is not recommended.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Cinitapride is evaluated for the following indications with varying evidence strength: Functional dyspepsia (evidence tier C), Gastroesophageal reflux disease (evidence tier D). See the full indication matrix with dosing and citations above on this page.
Common side effects of Cinitapride (≥ 1 in 100): Drowsiness, Fatigue, Headache, Abdominal pain, Diarrhea. See the Safety section for uncommon and serious reactions.
FDA category C. Contraindicated in pregnancy due to limited data and potential fetal neurological risk.
No data on milk excretion. Use in lactation is not recommended.
Cinitapride is contraindicated in: Cinitapride hypersensitivity; GI bleeding, perforation, or mechanical obstruction; Pheochromocytoma; Pregnancy; Age under 18. Full list in the Safety section.