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]
