Linaclotide Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 1, 2024.

Applies to linaclotide: oral capsule.

Important warnings This medicine can cause some serious health issues

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 linaclotide

Along with its needed effects, linaclotide 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

• severe diarrhea
• stomach pain

Less common

• heartburn
• loss of appetite
• nausea
• vomiting
• weakness

Incidence not known

• bleeding from the rectum
• bloody, black, or tarry stools
• chest tightness
• confusion
• cough
• decreased urination
• difficulty swallowing
• dizziness
• dry mouth
• fainting
• fast heartbeat
• hives or welts, itching, skin rash or redness
• increase in heart rate
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• loss of bowel control
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid breathing
• sunken eyes
• thirst
• trouble breathing
• unusual tiredness or weakness
• wrinkled skin

Other side effects of linaclotide

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 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

• 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

• What is the best way to take Linzess?

Further information

Linaclotide side effects can vary depending on the individual. 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