LINZESS® (linaclotide) Safety Profile Among CIC Patients

Not an actual patient.

Well-studied CIC safety profile¹

LINZESS was evaluated in three phase 3, placebo-controlled safety trials involving more than 2,400 adults with CIC

Table of common adverse reactions reported in ≥2% of Linzess patients and greater than placebo in trials 3, 4, and 5.

*“Abdominal pain” term includes the preferred terms: abdominal pain, upper abdominal pain, and lower abdominal pain.

In Trial 5, adverse reactions that occurred at a frequency of ≥2% in LINZESS 72 mcg–treated patients (n=411) and at a higher rate than placebo (n=401) were¹:

Diarrhea (LINZESS 72 mcg, 19%; LINZESS 145 mcg, 22%; placebo 7%)
Abdominal distension (LINZESS 72 mcg, 2%; LINZESS 145 mcg, 1%; placebo <1%)

Diarrhea was the most commonly reported adverse reaction of LINZESS¹

In Trials 3, 4, and 5, 2% of the patients treated with LINZESS 145 mcg experienced severe diarrhea vs less than 1% in patients  receiving placebo

The majority of reported cases of diarrhea occurred within the first 2 weeks of LINZESS treatment¹

INDICATIONS AND USAGE

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

irritable bowel syndrome with constipation (IBS-C) in adults
chronic idiopathic constipation (CIC) in adults
functional constipation (FC) in pediatric patients 6 to 17 years of age

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 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. In pediatric patients 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in one LINZESS-treated patient. 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 pediatric patients: diarrhea.

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

US-LIN-230215

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. © 2025 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.

US-LIN-240112

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
chronic idiopathic constipation (CIC) in adults
functional constipation (FC) in pediatric patients 6 to 17 years of age

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 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. In pediatric patients 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in one LINZESS-treated patient. 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 pediatric patients: diarrhea.

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

US-LIN-230215

CIC 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