Prucalopride

Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A , 5-HT 2B , 5-HT 3 , motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater.

• 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.ICD-10: K59.00

• Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride tablets. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see Adverse Reactions ( 6.2 )].contraindicated

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 )

Suicidal Ideation and Behavior: Monitor patients for suicidal ideation and behavior as well as self-injurious ideation and new-onset or worsening of depression. Instruct patients to discontinue prucalopride tablets immediately and contact their healthcare provider if they experience any unusual changes in mood or behavior, or they experience emerging suicidal thoughts or behaviors. ( 5.1 ) 5.1 Suicidal Ideation and Behavior In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. Postmarketing cases of suicidal ideation and behavior as well as self-injurious ideation and new onset or worsening of depression have been reported within the first few weeks of starting prucalopride tablets [see Adverse Reactions ( 6.1 , 6.2 )]. A causal association between treatment with prucalopride tablets and an increased risk of suicidal ideation and behavior has not been established. Monitor all patients treated with prucalopride tablets for new onset or worsening of depression or the emergence of suicidal thoughts and behaviors. Counsel patients, their caregivers, and family members of patients to be aware of any unusual changes in mood or behavior and alert the healthcare provider. Instruct patients to discontinue prucalopride tablets immediately and contact their healthcare provider if they experience any of these symptoms.

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below represent 2,530 patients (1,251 received prucalopride tablets 2 mg once daily and 1,279 received placebo) with CIC from 6 double-blind, placebo-controlled clinical trials of 12 weeks to 24 weeks in duration. In these trials overall, patients were primarily female (76%) and white (76%). The mean age was 47 years (range 17 to 95 years) [see Clinical Studies ( 14 )]. Common Adverse Reactions Table 2 below summarizes the incidence (%) of common adverse reactions occurring in at least 2% of patients with CIC receiving either 2 mg of prucalopride tablets once daily or placebo and at an incidence greater than in the placebo group from the six double-blind placebo-controlled trials described above.

8.1 Pregnancy Risk Summary Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In oral embryofetal development studies in rats and rabbits, prucalopride was administered to pregnant animals at doses of 5, 20, and 80 mg/kg/day throughout the period of organogenesis. No adverse embryofetal developmental effects were observed in either rats or rabbits up to the highest oral dose of 80 mg/kg/day (about 390 times and 780 times the recommended human dose of 2 mg/day, respectively, based on body surface area).

Metabolism

The pharmacokinetics of prucalopride has been evaluated in healthy subjects and is dose-proportional within and beyond the therapeutic range (tested up to 20 mg, 10 times the maximum approved recommended dose). Prucalopride administered once daily displays time-independent kinetics during prolonged treatment.

An overdose may result in appearance of symptoms from an exaggeration of the known pharmacodynamic effects of prucalopride and includes headache, nausea, and diarrhea. Specific treatment is not available for prucalopride tablets overdose. Should an overdose occur, treat symptomatically and institute supportive measures, as required. Extensive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.

• Dec 14, 2018NDANDA210166Takeda Pharms Usa
• Dec 26, 2024ANDAANDA218492Novitium Pharma
• Jun 24, 2025ANDAANDA219078Somerset Therap
• Jun 24, 2025ANDAANDA219160Annora Pharma
• Jun 24, 2025ANDAANDA219193Specgx Llc
• Jun 24, 2025ANDAANDA218177Msn
• Jun 24, 2025ANDAANDA217662Hikma
• Jun 24, 2025ANDAANDA218795Zenara

1. 1Drug Ineffective27811%
2. 2Headache26811%
3. 3Nausea2389.5%
4. 4Off Label Use2198.8%
5. 5Diarrhoea1857.4%
6. 6No Adverse Event1736.9%
7. 7Fatigue1696.8%
8. 8Constipation1556.2%
9. 9Dizziness1375.5%
10. 10Inability To Afford Medication1325.3%
11. 11Abdominal Pain1184.7%
12. 12Vomiting1154.6%
13. 13Product Use Issue1134.5%
14. 14Pain973.9%
15. 15Insurance Issue963.8%

The 10 most recently updated of 73 ClinicalTrials.gov registrations naming Prucalopride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Prucalopride in Breastfeeding Women With Constipation
  Recruiting · Observational · 12 enrolled · Takeda
  NCT04838522updated 2026-05-01
• Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
  Completed · Phase 4 · Interventional · 31 enrolled · KU Leuven
  NCT02425774updated 2026-03-20
• Gastrointestinal Dysmotility on Aspiration Risk
  Recruiting · Phase 4 · Interventional · 120 enrolled · Boston Children's Hospital
  NCT05455359updated 2025-12-26
• Prucalopride for Cognitive Functioning in Schizophrenia
  Not yet recruiting · Interventional · 34 enrolled · University of Pittsburgh
  NCT06474286updated 2025-12-02
• A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
  Active not recruiting · Observational · 100 enrolled · Takeda
  NCT04961840updated 2025-12-02
• Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults
  Not yet recruiting · Early phase 1 · Interventional · 124 enrolled · Hospital de Clínicas Dr. Manuel Quintela
  NCT07127237updated 2025-08-17
• Post-Marketing Study of Prucalopride Safety In Pregnancy
  Active not recruiting · Observational · 127 enrolled · Takeda
  NCT04869280updated 2025-08-13
• Evolution of the Chicago Classification: Bridging Physiology and Mechanics
  Recruiting · Interventional · 575 enrolled · Northwestern University
  NCT06883175updated 2025-08-11
• Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery
  Recruiting · Phase 3 · Interventional · 180 enrolled · Future University in Egypt
  NCT06816407updated 2025-03-19
• Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX
  Completed · Interventional · 8 enrolled · Medtronic - MITG
  NCT05022719updated 2024-10-15

Frequently asked questions

How does Prucalopride work?

Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A , 5-HT 2B , 5-HT 3 , motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater.

What is Prucalopride used for?

According to FDA labeling, Prucalopride carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Prucalopride?

Prucalopride is classified as Other drugs for constipation, Serotonin-4 Receptor Agonist, Serotonin 4 Receptor Agonists, Serotonin 4 Receptor Antagonists, Increased Large Intestinal Motility, Increased Smooth Muscle Acetylcholine Activity.

What are the brand names for Prucalopride?

Prucalopride is marketed under brand names including Motegrity.

What are the contraindications for Prucalopride?

Prucalopride labeling lists contraindications including: Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride tablets. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see Adverse Reactions ( 6.2 )].. Always consult the full prescribing information and a clinician.