Selective Serotonin (5-HT₄) Receptor Agonist — Prokinetic Pregnancy: Not recommended during pregnancy or in women of childbearing potential not using contraception; women of childbearing potential have to use effective contraception during treatment. There is a limited amount of data in pregnant women and cases of spontaneous abortion have been observed during clinical studies (relationship to prucalopride unknown in the presence of other risk factors). Prucalopride is excreted in breast milk — at therapeutic doses no effects on breast-fed newborns/infants are anticipated, but in the absence of human data a decision should be made whether to discontinue breast-feeding or therapy.

Prucalopride

Brand names: Constella, Resolor

Prucalopride is a prokinetic used for chronic constipation in adults when other laxatives have failed to provide adequate relief.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 2 mg

Route: Oral — with or without food

Frequency: Once daily, at any time of the day

Max: 2 mg daily — due to the specific mode of action (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy

If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered. Efficacy has been established in double-blind, placebo-controlled studies for up to 3 months; efficacy beyond three months has not been demonstrated in placebo-controlled studies, so in prolonged treatment the benefit should be reassessed at regular intervals. Older people (over 65 years): start with 1 mg once daily; if needed the dose can be increased to 2 mg once daily. Severe hepatic impairment (Child-Pugh class C): start with 1 mg once daily, which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated; no dose adjustment for mild to moderate hepatic impairment. Paediatric population: prucalopride should not be used in children and adolescents younger than 18 years.

Dose adjustments

Renal

Severe renal impairment (GFR less than 30 ml/min/1.73 m2): 1 mg once daily. No dose adjustment is required for mild to moderate renal impairment. Contraindicated in renal impairment requiring dialysis. Renal excretion is the main route of elimination.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Prucalopride tablets can be taken with or without food. The recommended dosage by patient population is shown in Table 1. Table 1: Recommended Dosage Regimen and Dosage Adjustments by Population Population with CIC Recommended Oral Dose Regimen Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) [ see Use in Specific Populations (8.5, 8.6 ) ] . 1 mg once daily Take with or without food. ( 2 ) Recommended dosage by patient population: Population with CIC Recommended Oral Dose Regimen Adults 2 mg once daily. ( 2 ) Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min 1 mg once daily. ( 2 , 8.5 , 8.6 )

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-12-04. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Renal impairment requiring dialysis
Intestinal perforation or obstruction due to structural or functional disorder of the gut wall
Obstructive ileus
Severe inflammatory conditions of the intestinal tract, such as Crohn disease and ulcerative colitis
Toxic megacolon/megarectum

Side effects

Headache (very common, 17.8%)
Abdominal pain (very common, 13.7%)
Nausea (very common, 13.7%)
Diarrhoea (very common, 12.0%)
Dizziness, decreased appetite, fatigue (common)
Vomiting, dyspepsia, flatulence, abnormal gastrointestinal sounds (common)

Interactions

Low pharmacokinetic interaction potential — extensively excreted unchanged in urine (approximately 60% of the dose), very slow in vitro metabolism, and no inhibition of specific CYP450 activities at therapeutically relevant concentrations
Erythromycin — a 30% increase in plasma erythromycin concentrations was found during prucalopride co-administration (mechanism unclear)
Ketoconazole (potent CYP3A4 and P-gp inhibitor) increased systemic exposure to prucalopride by approximately 40% — too small to be clinically relevant; interactions of similar magnitude may be expected with other potent P-gp inhibitors such as verapamil, ciclosporin A and quinidine
No clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives; probenecid, cimetidine, erythromycin and paroxetine did not affect prucalopride pharmacokinetics
Oral contraceptives — in case of severe diarrhoea their efficacy may be reduced and an additional contraceptive method is recommended (SPC 4.4)

Clinical monograph

How it works

It is a selective, high-affinity serotonin 5-HT4 receptor agonist that stimulates colonic motility and accelerates gastrointestinal transit.

Prescribing in practice

Reduce the dose in severe renal impairment, as clearance is reduced.
Headache, nausea, diarrhoea and abdominal pain are common, particularly in the first few days of treatment, and often settle with continued use.
Review the response after the recommended trial period and stop if there is no adequate benefit.

Monitoring

No routine laboratory monitoring is required; assess symptomatic response at review and reduce the dose where renal function is significantly impaired.

Counselling the patient

Early side effects such as headache and nausea often ease after the first few days.
Tell your doctor if it has not improved your symptoms after the agreed trial, so it can be reviewed.

Evidence & guidelines

Recommended for chronic constipation after other laxatives fail (NICE TA211; NICE CKS).

Reference: NICE TA211 Prucalopride for Chronic Constipation; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale · Neuromuscular

Pathways