Amitiza Side Effects

Generic name: lubiprostone

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

Some side effects of Amitiza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lubiprostone: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking lubiprostone (the active ingredient contained in Amitiza) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or ongoing nausea or diarrhea.

Common side effects may include:

• mild nausea, stomach pain;

• mild diarrhea, gas, bloating; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Gastrointestinal side effects have included nausea (31.1%), diarrhea (13.2%), abdominal distension (7.1%), abdominal pain (6.7%), flatulence (6.1%), vomiting (4.6%), loose stools (3.4%), and dyspepsia (2.9%). Other, less common reactions (less than 2%) have included gastroesophageal reflux disease, abdominal discomfort, dry mouth, constipation, and stomach discomfort. Watery stools, fecal incontinence, abnormal bowel sounds, frequent bowel movements, and retching have also been reported, but these effects are not necessarily attributed to dosing of lubiprostone.

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.

Respiratory side effects have included sinusitis (4.9%), upper respiratory tract infection (3.7%), nasopharyngitis (2.9%), dyspnea (2.4%), and influenza (2.0%). Other, less common reactions (less than 2%) have included pharyngolaryngeal pain, bronchitis, and cough. Asthma, painful respiration, and throat tightness have also been reported, but these effects are not necessarily attributed to dosing of lubiprostone.

Nervous system

Nervous system side effects have included headache (13.2%), dizziness (4.1%), and hypoesthesia (0.5%). Syncope, tremor, dysgeusia, paresthesia, and vertigo have also been reported, but these effects are not necessarily attributed to dosing of lubiprostone (the active ingredient contained in Amitiza)

General

General side effects have included peripheral edema (3.8%) and fatigue (2.3%). Other, less common reactions (less than 2%) have included chest discomfort, chest pain, and pyrexia. Rigors, pain, asthenia, malaise, and edema have also been reported, but these effects are not necessarily attributed to dosing of lubiprostone (the active ingredient contained in Amitiza)

Musculoskeletal

Musculoskeletal side effects have included arthralgia (3.1%), back pain (2.3%), pain in extremity (1.9%), and muscle cramp (1.0%).

Psychiatric

Psychiatric side effects occurring in less than 2% of patients have included depression, anxiety, and insomnia. Nervousness has also been reported, but this is not necessarily attributed to dosing of lubiprostone (the active ingredient contained in Amitiza)

Genitourinary

Genitourinary side effects have included urinary tract infections (4.4%).

Cardiovascular

Cardiovascular side effects have included hypertension (1%). Flushing and palpitations have also been reported, but these effects are not necessarily attributed to dosing of lubiprostone (the active ingredient contained in Amitiza)

Oncologic

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.

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