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Linaclotide Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 30, 2022.

Summary

Commonly reported side effects of linaclotide include: diarrhea. Other side effects include: flatulence. Continue reading for a comprehensive list of adverse effects.

Applies to linaclotide: oral capsules.

Warning

  • Contraindicated in infants and children <6 years of age; avoid use in children and adolescents 6 to <18 years of age.1 Single, clinically relevant, oral adult dose caused deaths due to dehydration in neonatal mice.1 (See Pediatric Use under Cautions.)

  • Safety and efficacy not established in patients <18 years of age.1

Side effects include:

Diarrhea, abdominal pain, flatulence, abdominal distension, viral gastroenteritis, headache, upper respiratory tract infection, sinusitis.

For Healthcare Professionals

Applies to linaclotide: oral capsule.

General

The most commonly reported side effects included diarrhea, abdominal pain, flatulence, and headache.[Ref]

Gastrointestinal

Abdominal distention occurred more frequently in patients given 72 mcg (2%) compared to patients given 145 mcg (1%) doses.

Diarrhea was a dose-related side effect. Approximately 33% of patients in a clinical trial developed diarrhea that resolved within 7 days; approximately 80% of patients in the same clinical trial developed diarrhea that lasted more than 28 days.[Ref]

Very common (10% or more): Diarrhea (up to 50%), moderate diarrhea (up to 47%), mild diarrhea (up to 43%)

Common (1% to 10%): Abdominal distension, abdominal pain, flatulence, severe diarrhea, viral gastroenteritis

Uncommon (0.1% to 1%): Defecation urgency, dyspepsia, fecal incontinence, gastroesophageal reflux disease, hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, nausea, rectal hemorrhage, vomiting

Frequency not reported: Lower abdominal pain, upper abdominal pain

Postmarketing reports: Hematochezia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory tract infection[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, orthostatic hypotension, rectal hemorrhage[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Rash

Postmarketing reports: Hives[Ref]

Metabolic

Uncommon (0.1% to 1%): Decreased appetite, dehydration, hypokalemia

Rare (less than 0.1%): Decreased blood bicarbonate[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Linzess (linaclotide)." Forest Pharmaceuticals (2012):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.