Summary of the safety profile: The most frequently reported adverse reactions with dexmedetomidine are hypotension, hypertension and bradycardia, occurring in approximately 25%, 15% and 13% of patients respectively.
Hypotension and bradycardia were also the most frequent dexmedetomidine-related serious adverse reactions occurring in 1.7% and 0.9% of randomised Intensive Care Unit (ICU) patients respectively.
Tabulated list of adverse reactions: The adverse reactions listed in Table 2 have been accumulated from pooled data of clinical trials in intensive care.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). (See Table 2.)
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