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.

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.

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.

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

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

Gastrointestinal

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 (the active ingredient contained in Amitiza) 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.[Ref]

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[Ref]

Respiratory

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.[Ref]

Rare (less than 0.1%): Dyspnea (1% or less)[Ref]

Nervous system

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

Musculoskeletal

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

Psychiatric

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

Genitourinary

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

Cardiovascular

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

Oncologic

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 (the active ingredient contained in Amitiza) on females has been reported to produce hepatocellular adenoma.

Other

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

Metabolic

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

Hepatic

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

Dermatologic

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

Hypersensitivity

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

References

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

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