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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Amitiza:Back pain; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain, upset, or bloating; tiredness; vomiting.
TopSevere 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.
Amitiza Side Effects - for the Professional
Amitiza
- Most common adverse reactions (incidence > 4%) in chronic idiopathic constipation are nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence (6.1)
- Most common adverse reactions (incidence > 4%) in irritable bowel syndrome with constipation are nausea, diarrhea, and abdominal pain (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals North America, Inc., at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 05/2008
| FULL PRESCRIBING INFORMATION: CONTENTS* | |
|---|---|
|
|
|
1.1 Chronic Idiopathic Constipation 1.2 Irritable Bowel Syndrome with Constipation 2.1 Chronic Idiopathic Constipation 2.2 Irritable Bowel Syndrome with Constipation 6.1 Clinical Studies Experience 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14.1 Chronic Idiopathic Constipation 14.2 Irritable Bowel Syndrome with Constipation 16 HOW SUPPLIED/STORAGE AND HANDLING |
|
FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
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
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.
Top
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
