Medication Guide App

Lubiprostone Side Effects

It is possible that some side effects of lubiprostone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to lubiprostone: oral capsule, oral capsule liquid filled

As well as its needed effects, lubiprostone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking lubiprostone, check with your doctor immediately:

More common
  • Diarrhea
  • full or bloated feeling or pressure in the stomach
  • nausea
  • stomach pain
  • swelling of abdominal or stomach area
Less common
  • Abdominal or stomach discomfort
  • black, tarry stools
  • blood in the stools
  • chest discomfort or pain
  • chills
  • cold or flu-like symptoms
  • cough
  • difficult or labored breathing
  • fever
  • general feeling of discomfort or illness
  • headache
  • increased sweating
  • joint pain
  • loss of appetite
  • loss of bowel control
  • muscle aches and pains
  • runny nose
  • shivering
  • shortness of breath
  • sore throat
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Abdominal or stomach tenderness
  • difficulty with swallowing
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • swelling

Get emergency help immediately if any of the following symptoms of overdose occur while taking lubiprostone:

Symptoms of overdose
  • Dry heaves
  • dry mouth
  • feeling of warmth
  • lack or loss of strength
  • paleness of the skin
  • redness of the face, neck, arms, and occasionally, upper chest
  • severe, unusual tiredness or weakness
  • weight loss

Some lubiprostone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Excess air or gas in the stomach or intestines
  • passing gas
Less common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • change in taste
  • cold sweats
  • difficult, burning, or painful urination
  • difficulty with moving
  • discouragement
  • dizziness
  • fear or nervousness
  • feeling sad or empty
  • frequent urge to urinate
  • heartburn
  • increased weight
  • indigestion
  • irritability
  • loss of interest or pleasure
  • loss of taste
  • lower back or side pain
  • muscle cramps
  • muscle stiffness
  • sore throat
  • stomach upset
  • swollen joints
  • tingling of the hands or feet
  • unusual drowsiness, dullness, tiredness, or feeling of sluggishness

For Healthcare Professionals

Applies to lubiprostone: oral capsule


In clinical trials, the incidence of nausea increased in a dose-dependent manner with the lowest overall incidence for nausea seen at the 24 mcg once daily dose (17.2%). Nausea decreased when lubiprostone was administered with food, and across all dose groups, the rate of nausea was substantially lower among men and elderly patients (13.2% and 18.6%, respectively).

The incidence of diarrhea did not appear to be dose-dependent. No clinically significant changes were seen in serum electrolyte levels while patients were receiving lubiprostone.

Very common (10% or more): Nausea (29%), diarrhea (12%)
Common (1% to 10%): Abdominal pain (8%), abdominal distension (6%), flatulence (6%), vomiting (3%), abdominal discomfort (3%), dyspepsia (2%)
Uncommon (0.1% to 1%): Dry mouth (1%), fecal incontinence (1% or less), vomiting (1% or less)
Rare (less than 0.1%): Constipation (1% or less), eructation (1% or less), gastroesophageal reflux disease (1% or less), gastritis (1% or less), anorexia (1% or less), hard feces (1% or less), rectal hemorrhage (1% or less)
Postmarketing reports: Ischemic colitis


Most reports of dyspnea have not been characterized as serious adverse events, but some patients have discontinued therapy because of dyspnea. These events have usually been described as a sensation of chest tightness and difficulty taking in a breath. Events generally have an acute onset within 30 to 60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses.

Rare (less than 0.1%): Dyspnea (1% or less)

Nervous system

Common (1% to 10%): Headache (2 to 11%), dizziness (3%)
Rare (less than 0.1%): Fatigue (1% or less)


Rare (less than 0.1%): Fibromyalgia (1% or less)
Postmarketing reports: Malaise, muscle cramps or muscle spasms, asthenia


Rare (less than 0.1%): Anxiety (1% or less), depression (1% or less), lethargy (1% or less)


Rare (less than 0.1%): Urinary tract infection (1% or less), pollakiuria (1% or less)


Common (1% to 10%): Chest discomfort/pain (2%)
Rare (less than 0.1%): Palpitations (1% or less)
Postmarketing reports: Syncope, tachycardia


Frequency not reported: Oncologic side effects in animal studies have included a significant increase in the incidence of interstitial cell adenoma of the testes. Also in animal studies, treatment with lubiprostone on females has been reported to produce hepatocellular adenoma.


Uncommon (0.1% to 1%): Peripheral edema (1%)
Rare (less than 0.1%): Edema (1% or less)


Rare (less than 0.1%): Blood potassium decreased (1% or less), increased weight (1% or less)


Rare (less than 0.1%): Increased alanine aminotransferase (ALT) (1% or less)


Rare (less than 0.1%): Erythema (1% or less)


Postmarketing reports: Hypersensitivity/allergic-type reactions (including rash, swelling, and throat tightness)

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