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Prucalopride

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are a serotonin-4 (5-HT.

Checked against the official label · Updated

Prescription medicine Oral

Prucalopride: quick answers

Used for
Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Usual adult dose
Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) [see Use in Specific Populations ].
Children
The safety and effectiveness of prucalopride tablets have not been established in pediatric patients.
With food?
Prucalopride tablets can be taken with or without food.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Jan 2026). Your prescription and pharmacist come first.

How to use Prucalopride

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

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.

How to take it and how often
  • 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 ]. 1 mg once daily
  • Take with or without food
  • Recommended dosage by patient 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) 1 mg once daily ]
Strengths it comes in

Prucalopride Tablets: 1 mg prucalopride: Yellow colored, round shaped, film coated tablets, debossed with "J" on one side and "7" on other side. 2 mg prucalopride: White colored, round shaped, film coated tablets, debossed with "J" on one side and "6" on other side. Tablets:1 mg, 2 mg of prucalopride

Children
  • The safety and effectiveness of prucalopride tablets have not been established
  • In pediatric patients
  • Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Takeda Pharmaceuticals U.S.A., Inc's MOTEGRITY (prucalopride) tablets
  • However, due to Takeda Pharmaceuticals U.S.A., Inc's marketing exclusivity rights, this drug product is not labeled with that information
Older adults

Of the 2,484 patients treated with Prucalopride tablets 1 mg or 2 mg once daily in 6 controlled trials of at least 12-week duration in patients with CIC, 15% were 65 years of age and over, and 5% were 75 years of age and over [see Clinical Studies (14) ]. No overall differences in safety and effectiveness were observed between elderly and younger patients. …

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information) Suicidal Ideation and Behavior: Inform patients, their caregivers, and family members that suicidal ideation and behavior, self-injurious ideation as well as new onset or worsening depression have been reported in patients treated with prucalopride tablets
  • Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior. …
Talk to a doctor first if
  • Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride
  • Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see Adverse Reactions ]
  • 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's disease, ulcerative colitis, and toxic megacolon/megarectum. …
Warnings

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 Suicidal Ideation and Behavior In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. …

Possible side effects

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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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. …

Pregnancy and breastfeeding

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. …

If you take too much

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 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.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-08.

How much Prucalopride costs

In other countries

Prices in other countries are not what you will pay where you live; they show how prices compare.

Brands around the world

Products with Prucalopride as the active ingredient. Names differ between countries.

Check your pack of Prucalopride

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Prucalopride

What is Prucalopride used for?

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. (From the official U.S. FDA label.)

How do I take Prucalopride?

Follow your prescription or the leaflet in your pack. The official label says: 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 Pop…

Should I take Prucalopride with food?

Prucalopride tablets can be taken with or without food.

Do I need a prescription for Prucalopride?

Usually yes. Prucalopride is a prescription medicine in most countries. Rules differ by country.

What brands contain Prucalopride?

Prucalopride is sold under names such as Motegrity. Brand names differ between countries.

What are the side effects of Prucalopride?

The official label lists: 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under wide… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Prucalopride?

The safety and effectiveness of prucalopride tablets have not been established in pediatric patients. Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Takeda Pharmaceuticals U.S.A., Inc's MOTEGRITY (prucalopride) tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc's marketing exclusivity rights, this drug product i… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Prucalopride when pregnant or breastfeeding?

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. … Ask your doctor or midwife first.

What happens if I take too much Prucalopride?

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 overdose. Should an overdose occur, treat symptomatically and institute support… Get medical help right away.

How can I check that my Prucalopride is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.