Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Syncope and Hypotension [see Warnings and Precautions (5.3) ] Dyspnea [see Warnings and Precautions (5.4) ] Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.
( 6.1 ) OIC: nausea and diarrhea.
( 6.1 ) IBS-C: nausea, diarrhea, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy's Laboratories Inc.
at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 lubiprostone for CIC, OIC, and IBS-C, 1648 patients were treated with lubiprostone 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 lubiprostone 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).
5 WARNINGS AND PRECAUTIONS Nausea : Patients may experience nausea;
concomitant administration of food may reduce this symptom.
( 2.2 , 5.1 ) Diarrhea : Avoid use in patients with severe diarrhea.
Instruct patients to discontinue lubiprostone and contact their healthcare provider if severe diarrhea occurs during treatment.
( 5.2 ) Syncope and Hypotension : May occur after taking the first dose or with subsequent doses.
Like all medications, Lubiprostone can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: