Plecanatide
Plecanatide is a prescription medicine that treats chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
🧬 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 1 clinical label set 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 →
Plecanatide (Trulance) is a once-daily tablet for adults with chronic idiopathic constipation (long-lasting constipation with no known cause) or irritable bowel syndrome with constipation; it mimics a natural gut hormone to draw fluid into the intestine and speed things along, and since about 2017 it has become a common next step after fiber and over-the-counter laxatives. Most adults tolerate it well, since little is absorbed, but diarrhea is common, occasionally severe early on, and some notice gas or bloating. Its boxed warning says it must never be given to children under 6 because of life-threatening dehydration, and should be avoided up to age 18.
Clinical pearls
- If diarrhea turns severe, often within the first few days, stop the medicine, drink fluids to rehydrate and call your prescriber.
- Do not use it if you have, or might have, a bowel blockage, so mention any past obstruction before starting.
- If swallowing tablets is hard or you use a feeding tube, the label spells out specific steps for crushing it.
- Store it well out of children's reach, and if a child or teen swallows any, contact a doctor promptly.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Trulance must never be given to children under 6 years old, because it can cause serious, life-threatening dehydration. In young mice, a single dose caused deaths from dehydration.
Children under 6 may be more likely to develop severe diarrhea. Avoid use in ages 6 to under 18 as well. Safety and effectiveness have not been established for anyone under 18. Watch for severe diarrhea, and get medical help right away if a child takes it.
Patient information guide A plain-language walkthrough of Plecanatide, written from its FDA label.
What Plecanatide is used for
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Plecanatide is used in adults for two types of constipation-related conditions.
- Chronic idiopathic constipation (CIC): long-lasting constipation with no known cause. Trulance is approved for this.
- Irritable bowel syndrome with constipation (IBS-C): Trulance is approved for this too.
How Plecanatide works
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Plecanatide is a copy of a natural gut hormone called uroguanylin. It binds to a receptor called guanylate cyclase-C on the inner lining of the intestine. This raises a signaling chemical called cGMP, which draws chloride and bicarbonate, and with them fluid, into the intestine. The extra fluid speeds movement and changes stool consistency.
In animal studies, higher cGMP outside the cells also quieted pain-sensing nerves in the gut.
Plecanatide dosage
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Trulance is a tablet taken by mouth once a day. You can take it with or without food.
- Swallow the tablet whole.
- If you miss a dose, skip it and take your next one at the regular time. Don't double up.
- Adults who can't swallow tablets, or who use a feeding tube, can follow the label's steps to crush the tablet and use applesauce or water. Ask your pharmacist to walk you through it.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Plecanatide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- CIC (chronic idiopathic constipation)
- 3 mg taken orally once daily
- Take with or without food. Swallow tablets whole. For adults with swallowing difficulties, tablets can be crushed and given in applesauce or water, or given with water via a nasogastric or gastric feeding tube.
- IBS-C (irritable bowel syndrome with constipation)
- 3 mg taken orally once daily
- Take with or without food. Swallow tablets whole. For adults with swallowing difficulties, tablets can be crushed and given in applesauce or water, or given with water via a nasogastric or gastric feeding tube.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended adult dosage of TRULANCE is CIC: 3 mg taken orally once daily. ( 2.1 ) IBS-C: 3 mg taken orally once daily. ( 2.1 ) Administration Instructions ( 2.2 ): Take with or without food. Swallow tablets whole. For patients who have difficulty swallowing tablets whole or those with a nasogastric or gastric feeding tube, see full prescribing information with instructions for crushing the tablet and administering with applesauce or water. 2.1 Recommended Dosage The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily. 2.2 Preparation and Administration Instructions Take TRULANCE with or without food [see Clinical Pharmacology (12.3) ] . If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time. Swallow a tablet whole for each dose. For adult patients with swallowing difficulties, TRULANCE tablets can be crushed and administered orally either in applesauce or with water or administered with water via a nasogastric or gastric feeding tube. Mixing TRULANCE crushed tablets in other soft foods or in other liquids has not been tested. Oral Administration in Applesauce: In a clean container, crush the TRULANCE tablet to a powder and mix with 1 teaspoonful of room temperature applesauce. Consume the entire tablet-applesauce mixture immediately. Do not store the mixture for later use. Oral Administration in Water: Place the TRULANCE tablet in a clean cup. Pour approximately 30 mL of room temperature water into the cup. Mix by gently swirling the tablet and water mixture for at least 10 seconds. The TRULANCE tablet will fall apart in the water. Swallow the entire contents of the tablet-water mixture immediately. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 10 seconds, and swallow immediately. Do not store the tablet-water mixture for later use. Administration with Water via a Nasogastric or Gastric Feeding Tube: Place the TRULANCE tablet in a clean cup with 30 mL of room temperature water. Mix by gently swirling the tablet and water mixture for at least 15 seconds. The TRULANCE tablet will fall apart in the water. Flush the nasogastric or gastric feeding tube with 30 mL of water using a catheter tip syringe.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Plecanatide side effects
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Diarrhea is by far the most common side effect.
Common side effects
- Diarrhea (the most common side effect)
- Gas (flatulence)
- Bloating or a swollen belly (abdominal distension)
- Abdominal tenderness
- Sinus infection or upper respiratory infection
- Nausea
- Dizziness
When to get medical help
- Severe diarrhea: stop the medicine, rehydrate, and call your doctor. It can happen within the first day or few days of treatment.
- Signs of an allergic reaction, such as itching, hives or rash: get medical help.
- Any child under 18 who has taken this medicine: contact a doctor promptly, because of the dehydration risk.
Severe diarrhea can happen, often within the first days. Stop the medicine, rehydrate and call your doctor. Itching, hives, rash and vomiting have also been reported after approval.
Plecanatide warnings and precautions
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- Dehydration in children: it can be life-threatening. It is not for children under 6 and should be avoided from ages 6 to under 18.
- Severe diarrhea: stop dosing and rehydrate if it occurs.
- Intestinal blockage: do not use if you have a known or suspected blockage.
Before taking Plecanatide
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- Do not take it if you have a known or suspected intestinal blockage.
- Never use it in children under 6. Avoid use from 6 to under 18.
- Pregnancy: human data are not enough to judge risk, though little of the drug is absorbed.
- Breastfeeding: the drug was not measurable in breast milk in a small study.
- Older adults: too few people 65 and older were studied to tell if they respond differently.
What Plecanatide does in the body
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Plecanatide increases fluid in the intestine and speeds how fast things move through it. In a study of a dose three times the recommended amount, people who took it after a meal reported looser stools than those who took it fasting, for up to 24 hours. In the clinical studies, it was taken with or without food.
How your body processes Plecanatide
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Very little plecanatide is absorbed into the blood. At the usual dose, it was mostly not measurable in blood samples. It works locally in the gut. There it is changed into an active form and then broken down into small peptides and amino acids. It did not affect the key liver enzymes CYP2C9 and CYP3A4 in lab tests.
How to store Plecanatide
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Store at room temperature, 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) . Protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Plecanatide
17 supplements and herbal products have documented interactions with Plecanatide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
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.
Plecanatide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Plecanatide — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I take it?
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What if I miss a dose?
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What side effects should I expect?
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Can my child take it?
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Is it safe in pregnancy or while breastfeeding?
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Is Plecanatide available over the counter?
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When was Plecanatide first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Plecanatide on HelloPharmacist
Plecanatide forms and strengths (how it comes)
Plecanatide 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Plecanatide inactive ingredients by manufacturer.
Tablet
How this form is used
- Trulance is used in adults for chronic idiopathic constipation (CIC).
- Trulance is used in adults for irritable bowel syndrome with constipation (IBS-C).
- Trulance is taken by mouth once daily, with or without food.
- Swallow Trulance tablets whole.
- If adults can't swallow tablets, the Trulance label describes crushing the tablet into applesauce or water, or giving it through a feeding tube.
- If you miss a Trulance dose, skip it and take the next dose at the regular time.
Plecanatide on the U.S. market: products, makers and brands
How Plecanatide 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 company lists 1 Plecanatide product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Trulance, Trulance Immediate release; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Plecanatide is used (Medicaid data)
A general measure of how commonly Plecanatide 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 Plecanatide 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.
How commonly is Plecanatide prescribed? Of the 1,601 medications we measure, Plecanatide ranks #654 by Medicaid prescriptions — more than 59% of them.
Utilization by Plecanatide 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.
plecanatide 3 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1873757
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 Plecanatide, 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 1 of 5 listed Plecanatide NDCs with Medicaid activity.
Compare Plecanatide products
A representative set of FDA-listed product records for Plecanatide — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 3 mg | Oral | Salix Pharmaceuticals Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Plecanatide NDCs →
Plecanatide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Plecanatide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Plecanatide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Plecanatide FDA approval history
How Plecanatide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Plecanatide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Plecanatide recalls since July 2021.
✅No Plecanatide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 1873752 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 1873756In current FDA listingsClinical drug / strength (SCD) 3 MGRxCUI 1873757
Look up RxCUI 1873752 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.
Plecanatide supply and shortage status
Whether Plecanatide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Plecanatide costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Feb 21, 2024). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 3 mg | $17.84 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Plecanatide brand names
Plecanatide is sold under 2 brand names in the FDA directory — Trulance, Trulance Immediate release. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Plecanatide: manufacturers and labelers
One company lists Plecanatide products with the FDA. By number of product records, the largest are Salix Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Plecanatide drug class (RxNorm)
Plecanatide belongs to the Guanylate Cyclase-C Agonist class.
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.
Sources for this Plecanatide page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Salix Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →