FDA-filed SPL labeling · retrieved through openFDA

Prucalopride

Prucalopride is a prescription tablet used to treat chronic idiopathic constipation (CIC) in adults.

Brand name Motegrity
Drug classes ⓘ Serotonin 4 Receptor Agonists
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 17, 2025
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ2018
FDA-listed product records ⓘ55
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Prucalopride at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Prucalopride (Motegrity) is a once-daily oral tablet that treats chronic idiopathic constipation in adults by stimulating the muscles in the colon to move stool more effectively. It is generally well tolerated, but patients and their families should be aware of a reported risk of new or worsening depression and suicidal thoughts, especially early in treatment. Always take it as prescribed, and contact your doctor immediately if your mood changes or you have thoughts of self-harm.
How we write & review this content — our editorial policy →

📖 Prucalopride: Patient Information Guide

A plain-language walkthrough of Prucalopride — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Prucalopride is an oral tablet used to treat chronic idiopathic constipation (CIC) in adults. All approved products share this indication:

  • Motegrity (film-coated tablet) is approved for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Prucalopride tablets (film-coated and uncoated) are approved for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Prucalopride succinate tablets are approved for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Prucalopride has not been shown to be effective in children and is not approved for pediatric use — a clinical study in patients aged 6 months to 17 years was stopped early because it did not demonstrate effectiveness.
⚙️How it works▾

Prucalopride selectively activates serotonin-4 (5-HT4) receptors in the wall of the gut. This triggers high-amplitude propagating contractions (HAPCs) — powerful, coordinated muscle movements in the colon that push contents toward the rectum. The result is faster colonic transit (the time it takes stool to travel through the large intestine) and more regular, complete bowel movements.

Importantly, prucalopride is highly selective for 5-HT4 receptors and does not significantly activate other serotonin receptor subtypes (such as 5-HT2A or 5-HT2B) at therapeutic levels, which helps limit effects outside the gut.

💊How it's taken▾

Prucalopride tablets are taken once daily by mouth, with or without food — eating does not affect how well the medication works. Your prescriber will determine the right dose for you based on your kidney function. Patients with severe kidney impairment (creatinine clearance less than 30 mL/min) need a lower daily dose, and the medication should be avoided entirely in patients on dialysis.

  • Take it at the same time each day to stay consistent.
  • If you miss a dose, follow your pharmacist's or prescriber's guidance — do not double up.
  • Do not adjust your dose on your own; always follow your prescriber's instructions.
🤒Side effects — in detail▾

The most common side effects with prucalopride — reported in at least 2% of patients in clinical trials — include:

  • Headache (the most frequently reported)
  • Abdominal pain or discomfort
  • Nausea
  • Diarrhea
  • Abdominal bloating (distension)
  • Dizziness
  • Vomiting
  • Gas (flatulence)
  • Fatigue

Many of these side effects are gut-related and may improve as your body adjusts. However, if you develop new or worsening depression, thoughts of self-harm, or signs of a serious allergic reaction (difficulty breathing, hives, facial swelling), stop the medication and contact your doctor right away.

⚠️Warnings & precautions▾
  • Suicidal ideation and behavior: Cases of suicidal thoughts, suicide attempts, self-harm, and new or worsening depression have been reported — especially within the first few weeks of starting prucalopride. While a direct cause-and-effect link has not been confirmed, all patients should be monitored closely. If you or someone close to you notices unusual mood changes or any suicidal thoughts, stop the medication immediately and call a healthcare provider.
  • Bowel obstruction or severe gut inflammation: Prucalopride must not be used in anyone with a bowel blockage, intestinal perforation, or serious inflammatory bowel conditions such as Crohn's disease, ulcerative colitis, or toxic megacolon. Stimulating gut contractions in these situations could be dangerous.
  • Kidney impairment: The drug is mainly cleared by the kidneys. People with severe kidney impairment need a lower dose, and those on dialysis should avoid it altogether.
  • Dehydration risk: Severe diarrhea or vomiting can lead to fluid and electrolyte loss. Seek medical attention if this becomes serious.
🔀What it interacts with▾

Prucalopride has limited significant drug interactions, but there is one worth knowing about:

  • Erythromycin (an antibiotic): Taking prucalopride together with erythromycin can raise erythromycin levels in the blood by a modest amount. This is not considered clinically significant at typical doses, but let your prescriber know if you are prescribed erythromycin.
  • Kidney-affecting medications: Because prucalopride is primarily cleared by the kidneys, anything that significantly changes kidney function may affect how much of the drug stays in your system. Always give your prescriber and pharmacist a complete list of your medications.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy: Do not take prucalopride if you have had a serious allergic reaction to it in the past (symptoms can include difficulty breathing, rash, hives, or facial swelling).
  • Bowel blockage or severe gut disease: Do not take it if you have an intestinal obstruction, perforation, or a severe inflammatory bowel condition such as Crohn's disease, ulcerative colitis, or toxic megacolon.
  • Kidney disease: Tell your doctor about any kidney problems. Severe kidney impairment requires a lower dose; end-stage kidney disease requiring dialysis is a reason to avoid this medication.
  • Pregnancy: Limited human data are available. Animal studies showed no harm at much higher doses, but data in pregnant women are insufficient to rule out risk. A pregnancy registry exists for Motegrity; ask your healthcare provider for details.
  • Breastfeeding: Prucalopride does pass into breast milk. Discuss the risks and benefits with your doctor before breastfeeding while on this medication.
  • Children: Safety and effectiveness have not been established in pediatric patients. A clinical study in children was stopped early due to lack of effectiveness.
  • Older adults: Elderly patients may have higher drug levels in their blood, largely because of reduced kidney function with age. Dose adjustments should be based on kidney function.
  • Mental health history: Because of the reported risk of suicidal thoughts and mood changes, tell your doctor if you have a history of depression or other mental health conditions.
🚑If you take too much▾

Taking too much prucalopride is likely to cause an exaggerated version of its normal effects — most commonly headache, nausea, and diarrhea. There is no specific antidote. Treatment focuses on managing symptoms and supporting the body, including replacing fluids and correcting any electrolyte imbalances caused by significant diarrhea or vomiting.

If you think you or someone else has taken too much, seek emergency medical help or contact Poison Control right away.

📡Pharmacodynamics — effects in the body▾

Prucalopride increases the frequency and strength of high-amplitude propagating contractions (HAPCs) — the powerful wave-like muscle movements that drive stool through the colon. In patients with chronic idiopathic constipation, once-daily dosing significantly reduced the average time it takes for contents to travel through the colon (colonic transit time) compared to placebo. At doses well above the therapeutic range, prucalopride does not meaningfully prolong the QT interval (an electrical measurement of heart rhythm), suggesting a low risk of cardiac effects at prescribed doses.

🔬Pharmacokinetics — how your body processes it▾

Prucalopride is well absorbed after oral dosing — more than 90% of the dose reaches the bloodstream — with peak blood levels occurring about 2 to 3 hours after a dose. Food does not affect absorption, so it can be taken at any time. The drug has a half-life of approximately one day, meaning it takes about a day for the body to clear half of a dose, and steady blood levels are typically reached within 3 to 4 days of once-daily dosing. The kidneys are the primary route of elimination, with the majority of the drug excreted unchanged in the urine; patients with reduced kidney function will have higher drug exposure and may need a dose adjustment.

📦How to store it▾

Store MOTEGRITY at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F) . Store MOTEGRITY in the original container to protect from moisture.

📄 Written from Prucalopride’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

74

Supplements & herbs that interact with Prucalopride

74 supplements and herbal products have documented interactions with Prucalopride in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 52
  • Minor · 19
ACTIVATED CHARCOAL Major LITHIUM Major ST. JOHN'S WORT Major 5-HTP Moderate ACETYL-L-CARNITINE Moderate AYAHUASCA Moderate BITTER MELON Moderate BLACK COHOSH Moderate +66 more
Every supplement checked against Prucalopride — ranked by severity The full interaction hub: 3 major · 52 moderate · 19 minor · every one linked to its full report. Check Prucalopride against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Prucalopride — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is chronic idiopathic constipation, and is that what this is for? ▾
Chronic idiopathic constipation — or CIC — is ongoing constipation where doctors can't find a specific underlying cause. It's not constipation from a medication or another disease; it just happens on its own and keeps coming back. Prucalopride is approved specifically for adults with this type of constipation. If you're unsure whether your constipation fits that description, it's worth a conversation with your doctor.
How soon will I notice it working? ▾
Prucalopride reaches steady, stable levels in your bloodstream within about 3 to 4 days of once-daily dosing, so many people start to notice a difference within the first week. The clinical studies ran for 12 to 24 weeks, so it's designed for ongoing use — not just a quick fix. If you're not seeing improvement after a few weeks, check in with your prescriber.
Can I take it with food, or does it need to be on an empty stomach? ▾
You can take prucalopride with or without food — it makes no difference to how well the medication is absorbed. Pick whatever time of day works best for your routine and stick with it so you don't miss doses.
I heard there's a warning about mood and mental health — should I be worried? ▾
It's something to be aware of, not necessarily scared of. Cases of new or worsening depression, suicidal thoughts, and self-harm have been reported with prucalopride, particularly in the first few weeks of treatment. A direct cause-and-effect link hasn't been proven, but the risk is taken seriously. Let people close to you know to watch for any changes in your mood. If you notice anything unusual — especially thoughts of self-harm — stop the medication and contact your doctor right away. This is especially important if you have a history of depression.
What side effects are most likely, and how do I know if something is serious? ▾
The most common side effects are headache, nausea, diarrhea, and abdominal pain — these are usually gut-related and often settle down after the first few days. Dizziness, bloating, vomiting, gas, and fatigue are also possible. These are annoying but not usually dangerous. The ones to act on quickly are signs of a severe allergic reaction (difficulty breathing, hives, swelling of the face), significant dehydration from diarrhea or vomiting, or any changes in mood or thoughts of self-harm.
Is it safe to take if I have kidney problems or if I'm pregnant? ▾
If you have kidney problems, definitely tell your doctor before starting — your dose may need to be lowered, and if you're on dialysis, this medication should be avoided altogether. For pregnancy, human data are very limited, so the decision needs to be made carefully with your doctor. If you're already taking it and become pregnant, there's a pregnancy registry for Motegrity you can enroll in. Prucalopride does pass into breast milk, so if you're breastfeeding, talk through the pros and cons with your healthcare provider.
Is Prucalopride available over the counter? ▾
Prucalopride is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Prucalopride first available? ▾
Prucalopride has been available in the United States since at least 2018, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Prucalopride? ▾
Prucalopride is supplied by 31 manufacturers listed in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc., Hikma Pharmaceuticals USA Inc, Novadoz Pharmaceuticals LLC.

💬 Answers drafted from Prucalopride’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Prucalopride supplement interactions74 checked — ranked by severity 🌿Drug & Supplement CheckerPrucalopride vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Prucalopride NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Prucalopride comes

Prucalopride is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Motegrity
How this form is used
What it may be used for
  • Motegrity is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Prucalopride succinate tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Important instructions
  • Motegrity can be taken with or without food, once daily.
  • Prucalopride tablets can be taken with or without food, once daily.
  • Prucalopride succinate tablets can be taken with or without food, once daily.
  • Patients with severe renal impairment (creatinine clearance less than 30 mL/min) require a lower once-daily dose — follow your prescriber's guidance.
Available strengths 2 strengths
1 mg 2 mg
44 FDA-listed product records ⓘ

📊 Prucalopride across the U.S. market

How Prucalopride appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
31
Manufacturers
3
Brand names
55
FDA-listed product records ⓘ
2018
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Takeda Pharmaceuticals America, Inc.7%
Hikma Pharmaceuticals USA Inc7%
Novadoz Pharmaceuticals LLC4%
Zydus Lifesciences Limited4%
Viona Pharmaceuticals Inc4%
SpecGx LLC4%
Other makers71%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Prucalopride is used

A general measure of how commonly Prucalopride is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Prucalopride is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

42,108
Medicaid prescriptions filled (Q1–Q4 2025)
$19.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Prucalopride prescribed? Of the 1,596 medications we measure, Prucalopride ranks #668 by Medicaid prescriptions — more than 58% of them.

Where Prucalopride ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #668 of 1,596
#663 Dapsone 42,610 Rx #664 Tezepelumab Injection 42,607 Rx #665 Dornase Alfa 42,474 Rx #666 Atenolol / Chlorthalid... 42,330 Rx #667 Ivabradine 42,299 Rx #668 Prucalopride 42,108 Rx #669 Gadoterate Meglumine 42,002 Rx #670 Linezolid 41,650 Rx #671 Trospium 41,279 Rx #672 Tofacitinib 41,140 Rx #673 Gentamicin Topical 41,105 Rx

Utilization by Prucalopride product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2 mg oral tablet is the most-dispensed Prucalopride product — about 87% of these Medicaid prescriptions.

prucalopride 2 MG Oral Tablet Most dispensed

36,461 Medicaid prescriptions (Q1–Q4 2025) 87% of Prucalopride prescriptions shown $16.7M gross reimbursement (before rebates) ≈ $458 per prescription (gross)

Summed across the 11 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2107353

prucalopride 1 MG Oral Tablet

5,647 Medicaid prescriptions (Q1–Q4 2025) 13% of Prucalopride prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $494 per prescription (gross)

Summed across the 8 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2107345

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Prucalopride, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 38 listed Prucalopride NDCs with Medicaid activity.

🔍 Compare Prucalopride products

A representative set of FDA-listed product records for Prucalopride — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 55 of 55 products — FDA National Drug Code Directory. See every product, package size and price: browse all 55 Prucalopride NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Prucalopride RxCUI 2107310 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2107344 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 2107345 2 MG RxCUI 2107353

Look up RxCUI 2107310 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Motegrity

🏭 Manufacturers & labelers

Takeda Pharmaceuticals America, Inc. 4 Hikma Pharmaceuticals USA Inc 4 Novadoz Pharmaceuticals LLC 2 Zydus Lifesciences Limited 2 Viona Pharmaceuticals Inc 2 SpecGx LLC 2 Somerset Therapeutics, LLC 2 SKG Pharma Inc. 2 Sandoz Inc. 2 Patheon Pharmaceuticals Inc. 2 Ajanta Pharma USA Inc. 2 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Cipla USA Inc. 2 Amneal Pharmaceuticals NY LLC 2 Camber Pharmaceuticals, Inc. 2 AvKARE 2 Lupin Pharmaceuticals, Inc. 2 ANI Pharmaceuticals, Inc. 2 Apotex Corp. 2 Shilpa Pharma Lifesciences Limited 1 Viyash Scientific Limited 1 Symed Labs Limited 1 Sun Pharmaceutical Industries Limited 1

…and 7 more on the FDA NDC directory.

RxNorm drug class

Prucalopride belongs to the Serotonin-4 Receptor Agonist class.

Pharmacologic class Serotonin-4 Receptor Agonist
Drug family (ATC) Other drugs for constipation
How it works Serotonin 4 Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 17, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Prucalopride.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Prucalopride after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
NDC products indexed
55
Distinct labelers/manufacturers represented
31
Linked representative label ⓘ
Takeda Pharmaceuticals America, Inc.
Linked label effective
Jul 17, 2025
Composite sections available
22
Linked SPL Set ID
bca1e4c6-4b2b-4876-8ab3-654629c4ff1b
Linked SPL Document ID
1278ace1-66f8-4bd8-8cf0-bd731f936563
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.