Adverse Drug Reactions in Sichuan Children During 2012-2014

Objective To determine the characteristics of adverse drug reactions (ADRs) in children. Methods Reported ADRs in the patients aged from 0-18 years were extracted from the 2012-2014 Sichuan ADR surveillance system. The time trend, category of ADRs 〔system organ class (SOC)〕, outcomes, and demographic characteristics of the patients were analyzed. Results The reported paediatric ADRs increased over time; most occurred in males (7 709, 56.40%) and preschool children (5 928, 43.37%). The majorities involved intravenous drips (8 492, 62.13%) and skin and appendages (7 510, 55.10%). About 267 (1.95%) cases were deemed as serious ADRs, most (120, 44.94%) involving whole body consequences. The majority (13 515, 98.87%) of patients recovered. But deaths (5, 0.04%) were also reported. Conclusion Pediatric ADRs are associated with young age (less than 5 years old) and intravenous drips. Serious ADRs should be identified for early interventions.