Prescription medicine
Plecanatide Brand names: Trulance
Plecanatide (Trulance) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the plecanatide FDA label on DailyMed (effective April 4, 2024, Salix Pharmaceuticals Inc.); the NDA 208745 record on Drugs@FDA; every plecanatide label on DailyMed.
Highlights of the record
FDA label of April 4, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS.
TRULANCE is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration [see Contraindications (4), Use in Specific Populations (8.4) ]. Avoid use of TRULANCE in patients 6 years to less than 18 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4) ]. The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. TRULANCE is contraindicated in patients less than 6 years of age; in young juvenile mice, plecanatide caused death due to dehydration. ( 4 , 8.4 ) Avoid use of TRULANCE in patients 6 years to less than 18 years of age. ( 5.1 , 8.4 ) The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age.
Used for
From the label: indications and usageTRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC).
Forms and strengths
- 3 mg
Tablet.
On the market
- Earliest approval on file
- January 19, 2017 Trulance, Salix; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 5, 2034 Trulance tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,995 through July 30, 2026
What is plecanatide used for?
From the label: indications and usageTRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C). TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of: chronic idiopathic constipation (CIC). ( 1 ) irritable bowel syndrome with constipation (IBS-C).
FDA pharmacologic class: Guanylate Cyclase-C Agonist.
Source: FDA drug label (Trulance Immediate release), Salix Pharmaceuticals Inc., effective April 4, 2024 (SPL set fe2895bf-71a6-493a-b0ca-e06b2dfefc82), via openFDA; the full label on DailyMed
What does the patient leaflet for plecanatide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRULANCE?Do not give TRULANCE to children who are less than 6 years of age. It may harm them. You should not give TRULANCE to children 6 years to less than 18 years of age. It may harm them. See “What are the possible side effects of TRULANCE?” for more information about side effects.
From the patient leaflet: How should I store TRULANCE?Store TRULANCE at room temperature between 68°F to 77°F (20°C to 25°C). Keep TRULANCE in a secure place and in the bottle that it comes in. The TRULANCE bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle. The TRULANCE bottle contains a polyester coil to help protect the tablets during shipping. Remove the polyester coil from the bottle and throw it away after opening the bottle. Keep the container of TRULANCE tightly closed and in a dry place. Safely throw away TRULANCE that is out of date or no longer needed. Keep TRULANCE and all medicines out of the reach of children.
Source: FDA drug label (Trulance Immediate release), Salix Pharmaceuticals Inc., effective April 4, 2024 (SPL set fe2895bf-71a6-493a-b0ca-e06b2dfefc82), via openFDA; the full label on DailyMed
Is there a generic for plecanatide (Trulance)?
No generic plecanatide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Trulance tablets: the compound patent runs to June 5, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for plecanatide?
The FDA Adverse Event Reporting System holds 1,995 reports that list plecanatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 281 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other guanylate cyclase-c agonists
- the pharmacologic class, with prices and generics
- Plecanatide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other