Prescription medicine
Linaclotide Brand names: Linzess
Linaclotide (Linzess) is a prescription medicine with an FDA approval on record since 2012. No generic is listed; pharmacies paid $9.02 per Linzess 145 mcg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the linaclotide FDA label on DailyMed (effective May 21, 2026, Allergan, Inc.); the NDA 202811 record on Drugs@FDA; every linaclotide label on DailyMed.
Highlights of the record
FDA label of May 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE.
LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing information for complete boxed warning. LINZESS is contraindicated in patients less than 2 years of age; in neonatal mice, linaclotide caused deaths due to dehydration.
Used for
From the label: indications and usageLINZESS is indicated for the treatment of:
irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older
chronic idiopathic constipation (CIC) in adults
functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pedi
Forms and strengths
Gelatin-coated capsule.
On the market
- Earliest approval on file
- August 30, 2012 Linzess, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first February 9, 2021; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 16, 2034 Linzess capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $9.02 per capsule Linzess 145 mcg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 26,525 through July 30, 2026
What is linaclotide used for?
From the label: indications and usageLINZESS is indicated for the treatment of:
irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older
chronic idiopathic constipation (CIC) in adults
functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. ( 1 ) Chronic idiopathic constipation (CIC) in adults. ( 1 ) Functional constipation (FC) in pediatric patients 2 years of age and older.
Conditions named in the indications of linaclotide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Guanylate Cyclase-C Agonist.
Source: FDA drug label (Linzess), NDA202811 (Abbvie), as published by Allergan, Inc., effective May 21, 2026 (SPL set 09beda19-56d6-4a56-afdc-9a77b70b2ef3), via openFDA; the full label on DailyMed
What does the patient leaflet for linaclotide 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 LINZESS?Do not give LINZESS to children who are less than 2 years of age. It may harm them. See the section “ What are the possible side effects of LINZESS? ” for more information about side effects.
From the patient leaflet: How should I store LINZESS?Store LINZESS at room temperature between 68°F to 77°F (20°C to 25°C). Keep LINZESS in the bottle that it comes in. The LINZESS bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle. Keep the bottle of LINZESS tightly closed and in a dry place. Keep LINZESS and all medicines out of the reach of children.
Source: FDA drug label (Linzess), NDA202811 (Abbvie), as published by Allergan, Inc., effective May 21, 2026 (SPL set 09beda19-56d6-4a56-afdc-9a77b70b2ef3), via openFDA; the full label on DailyMed
Is there a generic for linaclotide (Linzess)?
The FDA approved the first generic linaclotide on February 9, 2021. 3 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 7 patents for Linzess capsules: the compound patent runs to August 30, 2026 (pediatric exclusivity to February 28, 2027), and the last listed entry to February 16, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2021 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for linaclotide (Linzess)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.02 per Linzess 145 mcg capsule, down 50% from $18.15 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Linzess 72 mcg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Linzess 145 mcg capsule | Brand | $9.02 per capsule | $270.60 | -50% |
| Linzess 290 mcg capsule | Brand | $9.02 per capsule | $270.46 | -50% |
| Linzess 72 mcg capsule | Brand | $9.01 per capsule | $270.32 | -50% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has linaclotide been recalled?
The FDA's Enforcement Report lists 1 recall naming linaclotide since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for linaclotide?
The FDA Adverse Event Reporting System holds 26,525 reports that list linaclotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,064 are coded as a death and 3,921 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 else is labeled for the same conditions as linaclotide?
5 other medicines are given the same way (oral) and in the same FDA class as linaclotide or labeled mainly for the same use (irritable bowel syndrome), the same class first. Irritable bowel syndrome lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dicyclomine | Irritable bowel syndrome | 37 labelers | $0.059 per tablet 20 mg tablet | No current entry |
| Lubiprostone | Irritable bowel syndrome, Constipation | 10 labelers | $0.651 per capsule 24 mcg capsule | No current entry |
| Chlordiazepoxide and clidinium | Irritable bowel syndrome | 12 labelers | $0.256 per capsule Chlordiazepoxide-clidinium capsule | No current entry |
| Tenapanor | Irritable bowel syndrome, Constipation | none listed | $32.54 per tablet 50 mg tablet | No current entry |
| Eluxadoline | Irritable bowel syndrome | none listed | $28.09 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as linaclotide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to linaclotide
- 5 medicines for the same use
- Other guanylate cyclase-c agonists
- the pharmacologic class, with prices and generics
- Linaclotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other