The number of recorded adverse drug reactions was 1264 (25%) of the total number of records-notifications, of them 48 (3.8%) in the neonatal period, 420 (33%) — during the first year of life, and 393 (31%) — in early childhood. In 603 (47.7%) children with adverse drug reactions the drugs were prescribed with the following violations of instructions («off-label»): unregistered indications (218 — 36.1% of cases); presence of contraindications for use (125 — 20.7%); violation of the dosing schedule and length of treatment (187 — 31%); wrong drug dose calculation (117 — 19.4%); disregard of allergy history (13 — 2.1%); irrational choice of the introduction route (113 — 18.7%). Most often, instructions were violated when prescribing to children cefotaxime, ceftriaxone, and ibuprofen, with the prevailing inobservance of drug dosing schedule and irrational dose selection. The main part of «off-label» prescriptions was recorded in treatment of 29-day to 12-month-old patients.


A significant role in the development of adverse drug reactions in childhood belongs to ignoring officially approved instructions for medication use. The main medications prescribed «off-label» are cephalosporins; most frequent in pediatric practice are cases of an irrational choice of doses, and also violation of the drug introduction schedule. In order to improve the quality of drug therapy in childhood further development and improvement of the pharmacological surveillance system is necessary.

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