Substance / Medication

Linaclotide

Overview

Active Ingredient
linaclotide
RxNorm CUI
1307404

Indications

LINZESS 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 6 years of age and older

Labeler: Allergan, Inc.Updated: 2025-11-04T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

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 Po

Contraindications

When this intervention should not be used

LINZESS is contraindicated in: [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . Patients less than 2 years of age due to the risk of serious dehydration Patients with known or suspected mechanical gastrointestinal obstruction.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

Research Evidence

Published studies and systematic reviews

Sort:
Linaclotide combined with polyethylene glycol for bowel preparation in colonoscopy: a systematic review and meta-analysis of randomized controlled trials.
Meine Gilmara Coelho, Brennan Gregory Thomas, Delgado Lucas Monteiro et al. · Surg Endosc · 2026
PMID: 41168471Meta-Analysis
Combined linaclotide and polyethylene glycol electrolyte for colonoscopy preparation: a network meta-analysis of 14 randomized controlled trials.
Elgendy Mohamed S, Rajab Islam, Najah Qasi et al. · Int J Colorectal Dis · 2025
PMID: 40528061Meta-AnalysisFull text (PMC)
Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis.
Farag Ahmed, Genidy Amany Mahmoud, Raslan Mahmoud et al. · Arab J Gastroenterol · 2025
PMID: 41203453Meta-Analysis
Effects of linaclotide in the treatment of chronic constipation and irritable bowel syndrome with constipation: a meta-analysis.
Zhao Qi, Fang Yongkun, Yan Cheng et al. · Z Gastroenterol · 2022
PMID: 34215016Meta-Analysis
Effect of linaclotide in irritable bowel syndrome with constipation (IBS-C): a systematic review and meta-analysis.
Atluri D K, Chandar A K, Bharucha A E et al. · Neurogastroenterol Motil · 2014
PMID: 24351035Meta-Analysis
Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis.
Videlock Elizabeth J, Cheng Vivian, Cremonini Filippo · Clin Gastroenterol Hepatol · 2013
PMID: 23644388Meta-Analysis
Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial.
Cheng Li, Wang Qianqian, Wu Biyu et al. · J Gastroenterol Hepatol · 2025
PMID: 40079184RCT
Randomized controlled trial of linaclotide in children aged 6-17 years with functional constipation.
Di Lorenzo Carlo, Nurko Samuel, Hyams Jeffrey S et al. · J Pediatr Gastroenterol Nutr · 2024
PMID: 38533633RCT

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Linaclotide (substance)
SNOMED CT
703126002
UMLS CUI
C2000261
RxNorm CUI
1307404
Labeler
Allergan, Inc.

Clinical Data

This intervention maps to 6 entities in the Ltrl knowledge graph.

1
Conditions
2
Biomarkers
2
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.