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Amitiza Side Effects

Generic Name: lubiprostone

Note: This page contains information about the side effects of lubiprostone. Some of the dosage forms included on this document may not apply to the brand name Amitiza.

In Summary

Common side effects of Amitiza include: headache, diarrhea, and nausea. Other side effects include: urinary tract infection, peripheral edema, dizziness, vomiting, abdominal distention, abdominal pain, sinusitis, and flatulence. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lubiprostone: oral capsule, oral capsule liquid filled

In addition to its needed effects, some unwanted effects may be caused by lubiprostone (the active ingredient contained in Amitiza). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking lubiprostone:

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

If any of the following symptoms of overdose occur while taking lubiprostone, get emergency help immediately:

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

Minor Side Effects

Some of the side effects that can occur with lubiprostone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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


Very common (10% or more): Nausea (up to 29%), diarrhea (up to 12%)
Common (1% to 10%): Abdominal pain, abdominal distention, flatulence, vomiting, loose stools, abdominal discomfort, dyspepsia, dry mouth
Frequency not reported: Intestinal functional disorder, constipation, eructation, fecal incontinence, defecation urgency, frequent bowel movements, gastroesophageal reflux disease, gastritis, hard feces, rectal hemorrhage, pollakiuria
Postmarketing reports: Ischemic colitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope
Frequency not reported: Dysgeusia, tremor, lethargy[Ref]


Common (1% to 10%): Palpitations, hot flush
Postmarketing reports: Tachycardia/increased heart rate, hypotension[Ref]


Common (1% to 10%): Hyperhidrosis
Frequency not reported: Cold sweat, erythema
Postmarketing reports: Rash/urticaria[Ref]


Common (1% to 10%): Edema, fatigue, chest discomfort/pain, peripheral edema
Frequency not reported: Influenza, pain
Postmarketing reports: Malaise, asthenia, swelling[Ref]


Common (1% to 10%): Dyspnea
Frequency not reported: Pharyngolaryngeal pain, cough
Postmarketing reports: Throat tightness[Ref]


Uncommon (0.1% to 1%): Muscle spasms
Frequency not reported: Muscle cramps, joint swelling, myalgia, fibromyalgia[Ref]


Frequency not reported: Urinary tract infection[Ref]


Frequency not reported: Increased ALT and AST[Ref]


Frequency not reported: Electrolyte imbalance, decreased appetite, decreased blood potassium, increased weight, anorexia[Ref]


Frequency not reported: Anxiety, depression[Ref]


Postmarketing reports: Hypersensitivity/allergic-type reactions[Ref]


1. "Product Information. Amitiza (lubiprostone)." Sucampo Pharmaceuticals Inc, Bethesda, MD.

Not all side effects for Amitiza may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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