Linaclotide Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 30, 2022.
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.
- 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:
For Healthcare Professionals
Applies to linaclotide: oral capsule.
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]
Common (1% to 10%): Sinusitis, upper respiratory tract infection[Ref]
Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Rash
Uncommon (0.1% to 1%): Decreased appetite, dehydration, hypokalemia
Rare (less than 0.1%): Decreased blood bicarbonate[Ref]
More about linaclotide
- Check interactions
- Reviews (874)
- Dosage information
- During pregnancy
- Drug class: guanylate cyclase-C agonists
- En español
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Linzess (linaclotide)." Forest Pharmaceuticals (2012):
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.