There have been two confirmed reports of overdosage with AMITIZA. The first report involved a 3-year-old child who accidentally ingested 7 or 8 capsules of 24 mcg of AMITIZA and fully recovered. The second report was a study patient who self-administered a total of 96 mcg of AMITIZA per day for 8 days. The patient experienced no adverse reactions during this time. Additionally, in a Phase 1 cardiac repolarization study, 38 of 51 patients given a single oral dose of 144 mcg of AMITIZA (6 times the recommended dose) experienced an adverse event that was at least possibly related to the study drug. Adverse reactions that occurred in at least 1% of these patients included the following: nausea (45%), diarrhea (35%), vomiting (27%), dizziness (14%), headache (12%), abdominal pain (8%), flushing/hot flash (8%), retching (8%), dyspnea (4%), pallor (4%), stomach discomfort (4%), anorexia (2%), asthenia (2%), chest discomfort (2%), dry mouth (2%), hyperhidrosis (2%), and syncope (2%).

AMITIZA is contraindicated in patients with known mechanical gastrointestinal obstruction.

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