Precedex Adverse Reactions

Adverse event information is derived from all phase II/III clinical trials using continuous infusion of Precedex and from the subset of controlled infusion phase II/III trials for ICU sedation.
Phase II/III Continuous Infusion Trials: Adverse events include data from clinical trials of ICU sedation and perioperative administration in which 1337 patients received dexmedetomidine hydrochloride. Overall, the most frequently observed treatment-emergent adverse events considered by the investigator to have some relationship to study drug administration included hypotension, hypertension, bradycardia, nausea, dry mouth and hypoxia. (See Tables 2 and 3.)


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Click on icon to see table/diagram/image


Phase ll/lll Continuous Infusion ICU Sedation Trials: Adverse events include data from clinical trials of ICU sedation in which 576 patients received dexmedetomidine HCl. Overall, the most frequently observed treatment-emergent adverse events considered by the investigator to have some relationship to study drug administration included hypotension, hypertension, bradycardia, dry mouth, nausea and somnolence. (See Tables 4 and 5.)


Click on icon to see table/diagram/image




Click on icon to see table/diagram/image


Drud Abuse and Dependence: None known.