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Linzess Side Effects

Generic name: linaclotide

Medically reviewed by Drugs.com. Last updated on Jun 30, 2023.

Note: This document contains side effect information about linaclotide. Some dosage forms listed on this page may not apply to the brand name Linzess.

Applies to linaclotide: oral capsule.

Warning

Oral route (Capsule)

Linaclotide is contraindicated in pediatric 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.

Serious side effects of Linzess

Along with its needed effects, linaclotide (the active ingredient contained in Linzess) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking linaclotide:

More common

Less common

Incidence not known

Other side effects of Linzess

Some side effects of linaclotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to linaclotide: oral capsule.

General

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

Gastrointestinal

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]

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]

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

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.

Medical Disclaimer