In clinical trials, the most common adverse event was nausea (31%) . Other adverse events (≥5% of patients) included diarrhea (13%), headache (13%), abdominal distension (5%), abdominal pain (5%), flatulence (6%), sinusitis (5%), vomiting (5%), and fecal incontinence (1%). The FDA lists the following: For subjects with Chronic Idiopathic Constipation taking Amitiza: * Nausea ~ 29% (4% were severe, 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: ~12% (2% were severe, and 2% of patients discontinued treatment due to diarrhea) * Several less common adverse reactions (10%) were: Nausea , Diarrhea (7-12%), Headache (2-11%). Less common side effects (1-10%) included: Abdominal pain (4-8%), Abdominal distension (3-6%), Flatulence (4-6%), Vomiting (3%), Loose stools (3%), Edema (1-3%), Abdominal discomfort (1-3%), Dizziness (3%), Chest discomfort/pain (2%), Dyspnea (2%), Dyspepsia (2%), Fatigue (2%), Dry mouth (1%). Contraindications * Known or suspected mechanical GI obstruction. * Known hypersensitivity to<unk>  or any ingredient in the formulation. There is no current data on use in people with liver or kidney complications. The effects on pregnancy have not been studied in humans but testing in guinea pigs resulted in fetal loss. Amitiza is not approved for use in children.<unk>  is contraindicated in patients exhibiting chronic diarrhea, bowel obstruction, or diarrhea-predominant irritable bowel syndrome.
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