Prucalopride
Other Drugs For Constipation
Sold as Resolor · RESOTRAN
- Drug class
- Other Drugs For Constipation
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 55
- FDA reports (12 mo)
- 280
Overview
Prucalopride is an active pharmaceutical ingredient in the Other Drugs For Constipation group (A06AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 39 | May 22, 2026 |
| CA Canada | Health Canada | 12 | February 2, 2026 |
| US United States | FDA | 3 | January 8, 2026 |
| EU European Union | EMA | 1 | September 12, 2024 |
GBUnited Kingdom· MHRA
39 products
Uses
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
How to take
CACanada· Health Canada
12 products
Uses
RESOTRAN® (prucalopride succinate tablets) is indicated for: • The treatment of chronic idiopathic constipation in adult female patients in whom laxatives failed to provide adequate relief. There were an insufficient number of male patients in the clinical trials to demonstrate efficacy.
The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months. In case of prolonged treatment the benefit should be re-assessed at regular intervals. If treatment with prucalopride is not effective during the first 4 weeks, therapy should be discontinued.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): RESOTRAN® has been studied in subjects 65 years and older.
, 1 mg) (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 14 CLINICAL TRIALS).
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
How to take
Drug interactions
Known interactions involving Prucalopride. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB549370013 · revised June 7, 2024
- [2]Health Canada (DPD) · 02377012 · revised July 21, 2025
- [3]FDA DailyMed · 01dcea95-b391-79… · revised December 4, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/001012 · revised September 12, 2024
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.