Factors associated with adverse drug reactions in the newborn.

Risk factors associated with the occurrence of adverse drug reactions were evaluated in 1,200 neonates in an intensive care setting. Three-hundred-and-twenty-six neonates (27.1%) developed at least one ADR, 153 of whom had moderate to severe (fatal or life threatening) ADR. Severe prematurity (less than 28 weeks) gestation and diseases of prematurity (eg, RDS, apnea, and necrotizing enterocolitis) as well as the use of mechanical ventilation and parenteral nutrition were associated with highly significant increase in ADR occurrence. Impairment of liver and renal function both predisposed neonates to develop ADR.