Amitiza Side Effects

Generic Name: lubiprostone

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

Side Effects of Amitiza - for the Consumer

Amitiza

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amitiza:

Back pain; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain, upset, or bloating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Amitiza:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning or tingling of the skin; chest discomfort; depression; increased, decreased, or painful urination; irregular heartbeat; severe or persistent diarrhea or nausea; shortness of breath; swelling of the hands or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Amitiza Side Effects - for the Professional

Amitiza

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Chronic Idiopathic Constipation

Adverse reactions in dose-finding, efficacy, and long-term clinical studies: The data described below reflect exposure to Amitiza in 1175 patients with chronic idiopathic constipation (29 at 24 mcg once daily, 1113 at 24 mcg twice daily, and 33 at 24 mcg three times daily) over 3- or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure (≤ 4 weeks). The total population (N = 1491) had a mean age of 49.7 (range 19–86) years; was 87.1% female; 84.8% Caucasian, 8.5% African American, 5.0% Hispanic, 0.9% Asian; and 15.5% elderly (≥ 65 years of age). Table 1 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo. In addition, corresponding adverse reaction incidences in patients receiving Amitiza 24 mcg once daily is shown.

Table 1: Percent of Patients with Adverse Reactions (Chronic Idiopathic Constipation)

1Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator). 2This term combines "abdominal tenderness," "abdominal rigidity," "gastrointestinal discomfort," and "abdominal discomfort."
System/Adverse Reaction1	Placebo N = 316 %	Amitiza 24 mcg Once Daily N = 29 %	Amitiza 24 mcg Twice Daily N = 1113 %
Gastrointestinal disorders
Nausea	3	17	29
Diarrhea	< 1	7	12
Abdominal pain	3	3	8
Abdominal distension	2	-	6
Flatulence	2	3	6
Vomiting	-	-	3
Loose stools	-	-	3
Abdominal discomfort2	< 1	3	2
Dyspepsia	< 1	-	2
Dry mouth	< 1	-	1
Stomach discomfort	< 1	-	1
Nervous system disorders
Headache	5	3	11
Dizziness	< 1	3	3
General disorders and site administration conditions
Edema	< 1	-	3
Fatigue	< 1	-	2
Chest discomfort/pain	-	3	2
Respiratory, thoracic, and mediastinal disorders
Dyspnea	-	3	2

Nausea: Approximately 29% of patients who received Amitiza 24 mcg twice daily experienced an adverse reaction of nausea; 4% of patients had severe nausea while 9% of patients discontinued treatment due to nausea. The rate of nausea associated with Amitiza (any dosage) was substantially lower among male (7%) and elderly patients (18%). Further analysis of the safety data revealed that long-term exposure to Amitiza does not appear to place patients at an elevated risk for experiencing nausea. The incidence of nausea increased in a dose-dependent manner with the lowest overall incidence for nausea reported at the 24 mcg once daily dosage (17%). In open-labeled, long-term studies, patients were allowed to adjust the dosage of Amitiza down to 24 mcg once daily from 24 mcg twice daily if experiencing nausea. Nausea decreased when Amitiza was administered with food. No patients in the clinical studies were hospitalized due to nausea.

Diarrhea: Approximately 12% of patients who received Amitiza 24 mcg twice daily experienced an adverse reaction of diarrhea; 2% of patients had severe diarrhea while 2% of patients discontinued treatment due to diarrhea.

Electrolytes: No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving Amitiza.

Less common adverse reactions: The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite.

Irritable Bowel Syndrome with Constipation

Adverse reactions in dose-finding, efficacy, and long-term clinical studies: The data described below reflect exposure to Amitiza 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks. The total population (N = 1267) had a mean age of 46.5 (range 18–85) years; was 91.6% female; 77.5% Caucasian, 12.9% African American, 8.6% Hispanic, 0.4% Asian; and 8.0% elderly (≥ 65 years of age). Table 2 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 8 mcg twice daily and that occurred more frequently with study drug than placebo.

Table 2: Percent of Patients with Adverse Reactions (IBS-C Studies)

1Includes only those events associated with treatment (possibly or probably related, as assessed by the investigator).
System/Adverse Reaction1	Placebo N = 435 %	Amitiza 8 mcg Twice Daily N = 1011 %
Gastrointestinal disorders
Nausea	4	8
Diarrhea	4	7
Abdominal pain	5	5
Abdominal distension	2	3

Less common adverse reactions: The following adverse reactions (assessed by investigator as probably related to treatment) occurred in less than 1% of patients receiving Amitiza 8 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria.

One open-labeled, long-term clinical study was conducted in patients with IBS-C receiving Amitiza 8 mcg twice daily. This study comprised 476 intent-to-treat patients (mean age 47.5 [range 21–82] years; 93.5% female; 79.2% Caucasian, 11.6% African American, 8.6% Hispanic, 0.2% Asian; 7.8% ≥ 65 years of age) who were treated for an additional 36 weeks following an initial 12–16-week, double-blinded treatment period. The adverse reactions that were reported during this study were similar to those observed in the two double-blinded, controlled studies.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of Amitiza 24 mcg for the treatment of chronic idiopathic constipation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Voluntary reports of adverse reactions occurring with the use of Amitiza include the following: syncope, allergic-type reactions (including rash, swelling, and throat tightness), malaise, increased heart rate, muscle cramps or muscle spasms, and asthenia.

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Side Effects by Body System - for Healthcare Professionals

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 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.

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.

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.

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.

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 on females has been reported to produce hepatocellular adenoma.

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