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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

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

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

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%)
Common (1% to 10%): Abdominal pain, flatulence, abdominal distension, viral gastroenteritis, gastroesophageal reflux disease, vomiting, fecal incontinence, dyspepsia
Uncommon (0.1% to 1%): Defecation urgency[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Orthostatic hypotension[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Rash[Ref]

General

The most commonly reported reasons for treatment discontinuation were diarrhea and abdominal pain.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematochezia, melena, rectal hemorrhage[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration, hypokalemia, decreased appetite
Rare (less than 0.1%): Decreased blood bicarbonate[Ref]

Nervous system

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

Other

Common (1% to 10%): Fatigue

Respiratory

Common (1% to 10%): Upper respiratory tract infection, sinusitis[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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