This study was designed to characterize child reports in the national database during the period 2010-2012 in an overall drug and adverse drug reaction (ADR) review. A total of 1288 child reports were included in the study, of which 80 percent were serious ADR reports. The largest number of ADRs was reported for the 2-11 years age group (43.2 percent). ADRs were reported with higher proportion for males. The most frequently reported drugs group belonged to the "Antiinfectives for systemic use" ATC group (69.9 percent) and eight often most frequently reported drugs were antibiotics. Among specific drugs, cefotaxim was associated most commonly with ADRs (19.2 percent). "Skin and appendages disorders" were most commonly reported for children (56.6 percent), followed by "Body as a whole - general disorders" (24.9 percent). Six of ten most commonly reported drug-ADR pairs were related to antibiotic- skin and subcutaneous tissue disorders. Some serious and lifethreatening ADRs were identified such as anaphylactic reaction/anaphylactic shock, Stevens Johnson syndrome and toxic epidermal necrolysis.
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