LINZESS® (linaclotide) Safety Profile Among FC Patients

Not actual patients.

LINZESS was evaluated in a phase 3, placebo-controlled trial including 328 pediatric patients 6 to 17 years of age with functional constipation¹

Table of common adverse reactions reported in ≥2% of Linzess patients and greater than placebo in trial 7.

1 patient/<1% of LINZESS-treated patients reported severe diarrhea vs 0 placebo-treated patients.¹

1 patient/<1% of LINZESS-treated patients discontinued due to severe diarrhea vs 0 placebo-treated patients.¹

Most reported cases of diarrhea started within the first 2 weeks of LINZESS treatment.¹

INDICATIONS AND USAGE

LINZESS^® (linaclotide) 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

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions
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 neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients.

Diarrhea

In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of adult patients with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult patients with CIC treated with LINZESS 72 mcg once daily. In pediatric patients, diarrhea was also the most common adverse reaction of LINZESS-treated patients in IBS-C and FC clinical trials. In two double-blind trials, diarrhea was reported in 4% of pediatric patients 6 to 17 years of age with FC treated with LINZESS 72 mcg once daily, and 7% and 8% of pediatric patients 7 to 17 years of age with IBS-C treated with LINZESS 145 mcg and 290 mcg once daily, respectively. In clinical trials, severe diarrhea was reported in one pediatric patient with FC treated with LINZESS 72 mcg once daily and in one pediatric patient with IBS-C treated with LINZESS at a dose higher than the recommended 145 mcg once daily dosage for IBS-C. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension.
In FC or IBS-C pediatric patients: diarrhea.

Please see full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/linzess_pi.pdf

US-LIN-250120

Reference: 1. LINZESS. [package insert]. North Chicago, IL: AbbVie Inc.

Ironwood^® and its three-leaf design are registered trademarks of Ironwood Pharmaceuticals, Inc. LINZESS^® and its design are registered trademarks of Ironwood Pharmaceuticals, Inc. © 2026 AbbVie and Ironwood Pharmaceuticals, Inc. All rights reserved.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside the United States.

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.

INDICATIONS AND USAGE

LINZESS^® (linaclotide) 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

IMPORTANT SAFETY INFORMATION

WARNING:
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.

Contraindications

LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions
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 neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients.

Diarrhea

In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of adult patients with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult patients with CIC treated with LINZESS 72 mcg once daily. In pediatric patients, diarrhea was also the most common adverse reaction of LINZESS-treated patients in IBS-C and FC clinical trials. In two double-blind trials, diarrhea was reported in 4% of pediatric patients 6 to 17 years of age with FC treated with LINZESS 72 mcg once daily, and 7% and 8% of pediatric patients 7 to 17 years of age with IBS-C treated with LINZESS 145 mcg and 290 mcg once daily, respectively. In clinical trials, severe diarrhea was reported in one pediatric patient with FC treated with LINZESS 72 mcg once daily and in one pediatric patient with IBS-C treated with LINZESS at a dose higher than the recommended 145 mcg once daily dosage for IBS-C. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension.
In FC or IBS-C pediatric patients: diarrhea.

Please see full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/linzess_pi.pdf

US-LIN-250120

Pediatric functional constipation (6 years of age and older) safety data

INDICATIONS AND USAGE

LINZESS® (linaclotide) is indicated for the treatment of:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age

Diarrhea

Common Adverse Reactions (incidence ≥2% and greater than placebo)

IMPORTANT SAFETY INFORMATION

Contraindications

IMPORTANT SAFETY INFORMATION

Contraindications

IMPORTANT SAFETY INFORMATION

Contraindications

IMPORTANT SAFETY INFORMATION

Contraindications

INDICATIONS AND USAGE

LINZESS® (linaclotide) is indicated for the treatment of:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age

Diarrhea

Common Adverse Reactions (incidence ≥2% and greater than placebo)

LINZESS^® (linaclotide) is indicated for the treatment of:

Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age

LINZESS^® (linaclotide) is indicated for the treatment of:

Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age