Most common adverse reactions and related risk information1

LINZESS was evaluated in 4 Phase 3 placebo‑controlled trials involving more than 2800 adults with IBS‑C and CIC1

*"Abdominal pain" term includes the preferred terms: abdominal pain, upper abdominal pain, and lower abdominal pain.1

  • 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) were:
    • 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 placebo-controlled clinical trials, 2% of the IBS-C patients treated with LINZESS and less than 1% of the 72 mcg LINZESS–treated CIC patients and 2% of the 145 mcg LINZESS–treated CIC patients reported severe diarrhea vs less than 1% in patients receiving placebo
    • The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment
    • In post-marketing experience, severe diarrhea associated with dizziness, syncope, hypotension, and electrolyte abnormalities (hypokalemia and hyponatremia) requiring hospitalization or intravenous fluid administration have been reported in patients treated with LINZESS
    • If severe diarrhea occurs, suspend dosing and rehydrate the patient
  • The incidence of discontinuation due to adverse reactions in IBS-C was 9% of patients treated with LINZESS compared with 3% of patients treated with placebo (Trials 1 and 2). In CIC, 3% of patients treated with 72 mcg LINZESS (Trial 5) and between 5% (Trial 5) to 8% (Trials 3 and 4) of patients treated with 145 mcg LINZESS discontinued due to adverse reactions compared with less than 1% (Trial 5) to 4% (Trials 3 and 4) of placebo-treated patients1
    • In the LINZESS treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5% in IBS-C and in CIC 2% [72 mcg LINZESS] and 3% to 5% [145 mcg LINZESS]) and abdominal pain (1% in IBS-C and 1% in 145 mcg LINZESS). In comparison, less than 1% of all placebo patients withdrew due to diarrhea or abdominal pain

Please see below and full Prescribing Information, including Boxed Warning, for additional risk information.

Important Safety Information

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 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. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications
  • LINZESS is contraindicated in patients less than 6 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
Pediatric Risk
  • LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
  • 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. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).

If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about LINZESS, call Allergan Medical Information at 1.800.678.1605.

Please see below and full Prescribing Information for LINZESS.

Show
Important Safety Information

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 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. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications
  • LINZESS is contraindicated in patients less than 6 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
Pediatric Risk
  • LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
  • 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. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).

If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about LINZESS, call Allergan Medical Information at 1.800.678.1605.

Please see below and full Prescribing Information for LINZESS.