Linzess (linaclotide) is a guanylate cyclase-C agonist that is used for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC), and functional constipation (FC). Linzess was first approved in 2012 for treating IBS-C in adults, which has since been expanded to include pediatric patients seven years and older.
Learn more about Linzess, including its rundown of indications, warnings and precautions, and appearances in clinical guidelines, in today's monograph.
Medication Overview:
- Brand Name: Linzess
- Generic Name: Linaclotide
- Treatment for: IBS-C, CIC, FC
- Manufacturers: AbbVie, Ironwood Pharmaceuticals
- Initial FDA Approval: August 2012
Linzess (linaclotide) Indications Comparison
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Irritable Bowel Syndrome with Constipation (IBS-C) | Irritable bowel syndrome with constipation in adults and pediatric patients 7 years of age and older. | 7 and older | November 2025 |
| Chronic Idiopathic Constipation (CIC) | Chronic idiopathic constipation in adults. | Adults | January 2017 |
| Functional Constipation (FC) | Functional constipation in pediatric patients 6 years of age and older. | 6 and older | June 2023 |
Warnings and Precautions:
Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient.
Dosage and Administration:
The recommended dosage in adults is:
- IBS-C: 290 mcg orally once daily.
- CIC: 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability.
The recommended dosage in pediatric patients:
- 7 years of age and older with IBS-C: 145 mcg orally once daily.
- 6 years of age and older with FC: 72 mcg orally once daily.
Administration Instructions:
- Take on empty stomach at least 30 minutes prior to a meal at approximately the same time each day.
- Do not crush or chew Linzess capsule or capsule contents.
- For patients who have difficulty swallowing capsules whole or those with a nasogastric or gastrostomy tube, see full prescribing information for instructions for opening the capsule and administering with applesauce or water.
Contraindications:
Patients less than two years of age.
Patients with known or suspected mechanical gastrointestinal obstruction.
Adverse Reactions:
Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension.
Most common adverse reaction (≥2%) reported in pediatric patients with FC or IBS-C is diarrhea.
Examples of Linaclotide in Guidelines
Pharmacological Management of Chronic Idiopathic Constipation
- American Gastroenterological Association (AGA), June 2023
- “In adults with CIC who do not respond to OTC agents, the panel recommends the use of linaclotide over management without linaclotide.”
Pharmacological Management of Irritable Bowel Syndrome with Constipation
- American Gastroenterological Association (AGA), July 2022
- “In patients with IBS-C, the AGA recommends using linaclotide.”
Please note: This article is current as of November 7, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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