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Linzess Side Effects

Generic Name: linaclotide

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

In Summary

Common side effects of Linzess include: diarrhea. Other side effects include: flatulence. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to linaclotide: oral capsule

Warning

Oral route (Capsule)

Linaclotide is contraindicated in pediatric patients up 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. Avoid use of linaclotide in pediatric patients 6 to less than 18 years of age. The safety and efficacy of linaclotide has not been established in pediatric patients under 18 years of age.

Side effects requiring immediate medical attention

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

  • Abdominal or stomach pain
  • severe diarrhea

Less common

Rare

  • Bleeding from the rectum
  • bloody, black, or tarry stools
  • confusion
  • cough
  • decreased urination
  • difficulty swallowing
  • dizziness
  • dry mouth
  • fainting
  • fast heartbeat
  • hives or welts, itching, or skin rash or redness
  • increase in heart rate
  • lightheadedness
  • loss of bowel control
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid breathing
  • shortness of breath
  • sunken eyes
  • thirst
  • tightness in the chest
  • unusual tiredness or weakness
  • wrinkled skin

Side effects not requiring immediate medical attention

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

  • Body aches or pain
  • chills
  • ear congestion
  • excess air or gas in the stomach or intestines
  • fever
  • full or bloated feeling
  • headache
  • loss of voice
  • passing gas
  • sneezing
  • sore throat
  • stuffy or runny nose

Less common

  • Acid or sour stomach
  • belching
  • indigestion
  • pain or tenderness around the eyes and cheekbones
  • pressure in the stomach
  • stomach discomfort or upset
  • swelling of the abdominal or stomach area

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, nausea, 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]

Metabolic

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

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

Dermatologic

Frequency not reported: Rash

Postmarketing reports: Hives, urticaria[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, St. Louis, MO.

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.

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