Mild respiratory depression — ensure adequate monitoring.
Gastric irritation with nausea and vomiting.
In former premature infants , episodes of bradycardia may occur for up to 24 hours after a dose.
Paradoxical excitement may occur.
Prolonged administration or acute overdose can cause neurologic, respiratory and myocardial depression; cardiac arrhythmia and bladder atony.
Serious adverse events including death/permanent neurologic injury have been reported in children in a review of adverse event care reports from the adverse drug reporting system of the Food and Drug Administration, the US Pharmacopoeia, and the results of a survey of paediatric specialists.9
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