Amitiza
- Generic Name: lubiprostone
- Brand Name: Amitiza
Amitiza (Lubiprostone) side effects drug center
Amitiza Side Effects Center
What Is Amitiza?
Amitiza (lubiprostone) is a chloride channel activator used to treat chronic constipation in adults. Amitiza is also used to treat irritable bowel syndrome in women with constipation as the main symptom.
What Are Side Effects of Amitiza?
Common side effects of Amitiza include:
- nausea,
- stomach pain,
- diarrhea,
- gas,
- bloating,
- vomiting,
- dry mouth,
- runny nose,
- cough,
- fever,
- headache,
- dizziness,
- joint/back pain, or
- trouble sleeping.
Tell your doctor if you have unlikely but serious side effects of Amitiza including:
- severe diarrhea,
- swelling of arms or legs, and
- mental/mood changes.
Dosage for Amitiza?
To treat chronic idiopathic constipation, the recommended dose of Amitiza is 24 mcg twice daily orally with food and water. To treat irritable bowel syndrome with constipation, the recommended dose is 8 mcg twice daily orally with food and water.
What Drugs, Substances, or Supplements Interact with Amitiza?
There may be other drugs that can affect Amitiza. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Amitiza During Pregnancy and Breastfeeding
Amitiza is not recommended for use during pregnancy. Women should use birth control while taking this medication. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Amitiza (lubiprostone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Amitiza Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- trouble breathing;
- severe or ongoing nausea or diarrhea; or
- a light-headed feeling, like you might pass out.
You may have low blood pressure and feel faint shortly after taking lubiprostone, especially if you've been sick with vomiting or diarrhea. Stop taking lubiprostone and call your doctor if you feel light-headed after every dose.
Common side effects may include:
- nausea, stomach pain;
- 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Amitiza (Lubiprostone)
Amitiza Professional Information
SIDE EFFECTS
The following adverse reactions are described below and elsewhere in labeling:
- Nausea [see WARNINGS AND PRECAUTIONS]
- Diarrhea [see WARNINGS AND PRECAUTIONS]
- Syncope and Hypotension [see WARNINGS AND PRECAUTIONS]
- Dyspnea [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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.
During clinical development of Amitiza for CIC, OIC, and IBS-C, 1648 patients were treated with Amitiza for 6 months and 710 patients were treated for 1 year (not mutually exclusive).
Chronic Idiopathic Constipation
Adverse Reactions In Adult Dose-Finding, Efficacy, And Long-Term Clinical Studies
The data described below reflect exposure to Amitiza 24 mcg twice daily in 1113 patients with CIC 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 placebo population (N = 316) had a mean age of 48 (range 21 to 81) years; was 87% female; 81% Caucasian, 10% African American, 7% Hispanic, 1% Asian, and 12% elderly (≥65 years of age). Of those patients treated with Amitiza 24 mcg twice daily (N=1113), the mean age was 50 (range 19-86) years; 87% were female; 86% Caucasian, 8% African American, 5% Hispanic, 1% Asian, and 17% elderly (≥65 years of age).
The most common adverse reactions (>4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.
Table 2 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with Amitiza than placebo.
Table 2: Adverse Reactions* in Clinical Trials of Adults with CIC
| System/Adverse Reaction | Placebo N = 316 % | Amitiza 24 mcg Twice Daily N = 1113 % |
| Nausea | 3 | 29 |
| Diarrhea | 1 | 12 |
| Headache | 5 | 11 |
| Abdominal pain | 3 | 8 |
| Abdominal distension | 2 | 6 |
| Flatulence | 2 | 6 |
| Vomiting | 0 | 3 |
| Loose stools | 0 | 3 |
| Edema | <1 | 3 |
| Abdominal discomfort† | 1 | 3 |
| Dizziness | 1 | 3 |
| Chest discomfort/pain | 0 | 2 |
| Dyspnea | 0 | 2 |
| Dyspepsia | <1 | 2 |
| Fatigue | 1 | 2 |
| Dry mouth | <1 | 1 |
| *Reported in at least 1% of patients treated with Amitiza and greater than placebo † This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.” | ||
Nausea: Approximately 29% of patients who received Amitiza experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea. The rate of nausea was lower among male (8%) and elderly (19%) patients. No patients in the clinical studies were hospitalized due to nausea.
Diarrhea: Approximately 12% of patients who received Amitiza experienced diarrhea; 2% of patients had severe diarrhea and 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 (<1%): 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.
Opioid-Induced Constipation
Adverse Reactions In Adult Efficacy And Long-Term Clinical Studies
The data described below reflect exposure to Amitiza 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks.
The total population (N = 1492) had a mean age of 50 (range 20-89) years; was 63% female; 83% Caucasian, 14% African
American, 1% American Indian/Alaska Native, 1% Asian; 5% were of Hispanic ethnicity, and 9% were elderly (≥65 years of age).
The most common adverse reactions (>4%) in OIC were nausea and diarrhea.
Table 3 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.
Table 3: Adverse Reactions* in Clinical Trials of Adults with OIC
| System/Adverse Reaction* | Placebo N = 632 % | Amitiza 24 mcg Twice Daily N = 860 % |
| Nausea | 5 | 11 |
| Diarrhea | 2 | 8 |
| Abdominal pain | 1 | 4 |
| Flatulence | 3 | 4 |
| Abdominal distension | 2 | 3 |
| Vomiting | 2 | 3 |
| Headache | 1 | 2 |
| Peripheral edema | <1 | 1 |
| Abdominal discomfor† | 1 | 1 |
| *Reported in at least 1% of patients treated with Amitiza and greater than placebo † This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.” | ||
Nausea: Approximately 11% of patients who received Amitiza experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea.
Diarrhea: Approximately 8% of patients who received Amitiza experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea.
Less common adverse reactions (<1%): fecal incontinence, blood potassium decreased.
Irritable Bowel Syndrome With Constipation
Adverse reactions in adult 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 47 (range 18-85) years; was 92% female; 78% Caucasian, 13% African American, 9% Hispanic, 0.4% Asian, and 8% elderly (≥65 years of age).
The most common adverse reactions (>4%) in IBS-C were nausea, diarrhea, and abdominal pain.
Table 4 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.
Table 4: Adverse Reactions* in Clinical Trials of Adults with IBS-C
| System/Adverse Reaction | Placebo N = 435 % | Amitiza 8 mcg Twice Daily N = 1011 % |
| Nausea | 4 | 8 |
| Diarrhea | 4 | 7 |
| Abdominal pain | 5 | 5 |
| Abdominal distension | 2 | 3 |
| * Reported in at least 1% of patients treated with Amitiza and greater than placebo | ||
Nausea: Approximately 8% of patients who received Amitiza 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea.
Diarrhea: Approximately 7% of patients who received Amitiza 8 mcg twice daily experienced diarrhea; <1% of patients had severe diarrhea and <1% of patients discontinued treatment due to diarrhea.
Less common adverse reactions (<1%): 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.
Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of Amitiza. 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.
Cardiovascular: syncope and/or hypotension [see WARNINGS AND PRECAUTIONS], tachycardia
Gastrointestinal: ischemic colitis
General: asthenia
Immune System: hypersensitivity reactions including rash, swelling, and throat tightness malaise
Muscoskeletal: muscle cramps or muscle spasms.
Read the entire FDA prescribing information for Amitiza (Lubiprostone)
&Copy; Amitiza Patient Information is supplied by Cerner Multum, Inc. and Amitiza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.