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LINZESS
  • LINZESS
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  • INDICATIONS
    • Adults with IBS-C
    • Efficacy data
    • Safety data
    • Mechanism of action
    • Patient profiles
    • Adults with CIC
    • Efficacy data
    • Safety data
    • Mechanism of action
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Dosing

Indications

Adults with IBS-C

Efficacy data

Safety data

Mechanism of action

Patient profiles

Adults with CIC

Efficacy data

Safety data

Mechanism of action

Patient profile

Functional constipation
(6-17 years of age)

Efficacy data

Safety data

Mechanism of action

Patient profile

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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

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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

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US-LIN-240112

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Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

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You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

Do you wish to leave this site?

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You are about to leave LINZESSHCP.com

You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links for such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of LINZESSHCP.com or AbbVie.

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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