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

Summary

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

Applies to lubiprostone: oral capsule liquid filled.

Serious side effects of Amitiza

Along with its needed effects, lubiprostone (the active ingredient contained in Amitiza) 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 lubiprostone:

More common

• Diarrhea
• full or bloated feeling or pressure in the stomach
• nausea
• stomach pain
• swelling of the abdominal or stomach area

Less common

• Black, tarry stools
• blood in the stools
• chest discomfort or pain
• chills
• colds
• 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
• sore throat
• stomach discomfort
• sweating
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Blurred vision
• confusion
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• hives or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stomach tenderness
• 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

Other side effects of Amitiza

Some side effects of lubiprostone 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

• Excess air or gas in the stomach or intestines
• passing gas

Less common

• 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
• 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.

Gastrointestinal

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]

Cardiovascular

Common (1% to 10%): Palpitations, hot flush

Postmarketing reports: Tachycardia/increased heart rate, hypotension^[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis

Frequency not reported: Cold sweat, erythema

Postmarketing reports: Rash/urticaria^[Ref]

Other

Common (1% to 10%): Edema, fatigue, chest discomfort/pain, peripheral edema

Frequency not reported: Influenza, pain

Postmarketing reports: Malaise, asthenia, swelling^[Ref]

Respiratory

Common (1% to 10%): Dyspnea

Frequency not reported: Pharyngolaryngeal pain, cough

Postmarketing reports: Throat tightness^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasms

Frequency not reported: Muscle cramps, joint swelling, myalgia, fibromyalgia^[Ref]

Genitourinary

Frequency not reported: Urinary tract infection^[Ref]

Hepatic

Frequency not reported: Increased ALT and AST^[Ref]

Metabolic

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

Psychiatric

Frequency not reported: Anxiety, depression^[Ref]

Hypersensitivity

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