Central and peripheral nervous system and psychiatric disorders: somnolence and prolonged sedation, alertness decreased, confusional state, euphoric mood, hallucinations, fatigue, headache, dizziness, ataxia, postoperative sedation and anterograde amnesia, the duration of which is directly related to the administered dose. Anterograde amnesia may persist at the end of the procedure and in isolated cases prolonged amnesia has been reported.
Paradoxical reactions such as agitation, involuntary movements (including tonic/clonic seizures and muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement and assault, particularly in children and elderly, have been reported.
Seizures have been more frequently reported in neonates and premature infants.
The use of midazolam-even therapeutic doses-may enhance the development of a physical dependence after a prolonged IV administration; the abrupt drug discontinuation may be accompanied by withdrawal symptoms, such as seizures.
Gastrointestinal disorders: nausea, vomiting, constipation, hiccup and dry mouth.
Cardiorespiratory disorders: severe cardiorespiratory adverse events; respiratory depression, apnea, respiratory arrest or cardiac arrest, hypotension, heart rate disorder, vasodilator effects, dyspnea and glottis spasm Life-threatening incidents are more likely to occur in case of adults older than 60 years old and of those patients with prior respiratory failure or impairment of cardiac function, particularly when the injection is administered too rapidly or when a high dose is applied.
General disorders: general hypersensitivity reactions: skin reactions, cardiovascular reactions, bronchospasm, anaphylactic shock.
Administration site disorders: erythema and pain on injection site, thrombophlebitis and thrombosis.
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