Adverse drug reactions in children are serious public health problem. The overall incidence of ADRs is estimated at about 9.5% in hospitalized children and about 1.5% for outpatient children. ADRs have very diverse manifestations from minor skin rashes to potentially life-threatening severe skin reactions such as: acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylactic reactions. The aim of the study was to analyze the results of ADRs monitoring with particular regard to life-threatening reactions in the pediatric population in Poland. We analyzed spontaneous reports of ADRs in Poland in patients aged 0-18 years in the period 01.01.2004-31.03.2013. Each reported case was evaluated and classified by a clinical pharmacologist and an allergologist. Analysis of the data showed the occurrence of ADR in 846 pediatric patients including one case of Stevens-Johnson syndrome, and 90 (10.6% ADR) drug reactions classified as anaphylactic reactions (44 responses (5.2% ADR)) and non-immune anaphylaxis (46 responses (5.4% ADR)). Classes of drugs most frequently causing anaphylactic reactions were: anti-inflammatory and antipyretic (31%), antibiotics (19%) and drugs used in anesthesia (16%). The substances most commonly causing anaphylactic reactions/non-immune anaphylaxis were: paracetamol and lidocaine (with 8 responses). The most common clinical manifestations of ADRs are skin reactions (402 responses, 47.5%). Acute drug reactions in the pediatric population may have life-threatening clinical manifestations. Drugs that most commonly cause anaphylaxis are: anti-inflammatory/ antipyretic drugs (acetaminophen, aspirin, ibuprofen), antibiotics (cephalosporins, amoxicillin, sulfonamides), local anesthetics (lidocaine). Early diagnosis of allergy and choice of safe product can prevent life-threatening drug reactions.