Allergy Asthma Respir Dis AARD Allergy, Asthma & Respiratory Disease 2288-0402 2288-0410 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology 10.4168/aard.2016.4.5.354 Original Article Pediatric adverse drug reactions collected by an electronic reporting system in a single tertiary university hospital Park Geun-Mi 1 Park Joo Hyun 1 Jung Joo Won 1 Han Hye Won 1 Kim Jae Youn 1 Lee Eun 2 3 Cho Hyun-Ju 2 3 Kim Yeongho 2 3 Yoon Jisun 2 3 Yu Jinho 2 Kim Tae-Bum 4 http://orcid.org/0000-0003-1409-2113 Hong Soo-Jong 2 3 Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Department of Pediatrics, Childhood Asthma Atopy Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Environmental Health Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Allergy and Clinical Immunology, Asan Regional Pharmacovigilance Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Correspondence to: Soo-Jong Hong. Department of Pediatrics, Childhood Asthma Atopy Center, Environmental Health Center, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea. Tel: +82-2-3010-3379, Fax: +82-2-473-3725, sjhong@amc.seoul.kr 09 2016 30 09 2016 4 5 354 359 02 02 2016 20 04 2016 27 04 2016 © 2016 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology 2016 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/). Purpose

The incidence of adverse drug reactions (ADRs) is increasing. However, studies on the prevalence of ADRs in children are rare. The aim of this study was to investigate the causative drugs and clinical features of ADRs for children in a tertiary university hospital of Korea.

 Methods

We retrospectively collected ADRs by a computerized self-reporting system in Asan Medical Center. ADRs of children under the age 18 were collected from January 2005 to August 2015, and we analyzed only ADRs containing current symptoms among total ADR data.

 Results

A total of 1,408 ADR cases were reported, There were 764 male (54.3%) and 644 female patients (45.7%), and the mean age was 11.5±5.8 years (range, 0–18 years). Antibiotics (n=479, 34.0%) were the most common causative drugs, followed by tramadol (n=173, 12.3%), nonsteroidal anti-inflammatory agents (NSAIDs) and acetylsalicylic acid (n=103, 7.3%), narcotics (n=91, 6.5%), antineoplastics (n=87, 6.2%), and sedatives (n=82, 5.8%). The most common clinical features were skin manifestations (n=500, 34.4%). Gastrointestinal symptoms (n=435, 29.9%) were the second most common clinical features, followed by neuropsychiatric symptoms (n=155, 10.7%) and respiratory symptoms (n=123, 8.5%). Among antibiotics, glycopeptides (n=110, 23.0%), third-generation cephalosporins (n=83, 17.3%), and penicillin/β-lactamase inhibitors (n=60, 12.7%) were the most frequently reported causative drugs.

 Conclusion

Antibiotics were the most reported common causative drugs of ADRs in children, followed by tramadol, NSAID, and narcortics. Compared with adults, the prevalence of contrast medium-induced ADR was lower in children with a higher prevalence of sedative-associated ADR. Greater attention to possible ADRs in children is needed among medical personnel.

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Characteristic Value
No. of reports 1,408
Male sex 764 (54.3)
Age (yr) 11.5±5.8
 0–1 137 (9.7)
 2–6 221 (15.7)
 7–12 279 (19.8)
 13–18 771 (54.8)

Values are presented as number of reports (%) or mean±standard deviation.

 Frequency of drug to cause the adverse reactions
Classification No. (%)
Antibiotics 479 (34.0)
Tramadol 173 (12.3)
NSAIDs and aspirin 103 (7.3)
Narcotics 91 (6.5)
Antineoplastic 87 (6.2)
Sedatives 82 (5.8)
GI regulator 45 (3.2)
Contrast medium 36 (2.6)
Acetaminophen 26 (1.8)
Anticonvulsant 24 (1.7)
Antiulcerants 24 (1.7)
Vitamin 23 (1.6)
Electrolyte, caloric, and water 17 (1.2)
Antitussives 12 (0.9)
Steroids 13 (0.9)
Antihistamine 12 (0.9)
Bronchodilator 12 (0.9)
Anesthetics 12 (0.9)
Vaccines 9 (0.6)
Cardiovascular 6 (0.4)
Topical drug 7 (0.5)
Others 115 (8.2)
Total 1,408 (100)
Clinical manifestations and proportion of adverse drug reaction
Classification Clinical manifestations (No.) No. of reports (%)
Skin Skin eruption (228), urticaria (118), itching (102), angioedema (26), others (26) 500 (34.4)
Gastrointestinal Nausea (246), vomiting (120), diarrhea (45), abdominal pain (20), others(4) 435 (29.9)
Neuropsychiatric Dizziness (87), depression · anxiety (22), headache (16), behavioral disorder (16), mental deterioration (11), insomnia (3) 155 (10.7)
Respiratory Dyspnea (100), chest tightness (11), coughing (6), wheezing (4), rhinorrhea · nasal obstruction (2) 123 (8.5)
Generalized Fever (26), anaphylaxis (19), edema (6), myalgia (3) 54 (3.7)
Cardiovascular Hypotension (22), palpitation·arrhythmia (10), shock (13) 45 (3.1)
Hepatotoxicity Elevated liver enzyme (7), jaundice (1) 8 (0.5)
Hematology Thrombocytopenia (2), pancytopenia (3), neutropenia (1) 6 (0.4)
Renal & urinary Urinary retention (1) 1 (0.1)
Others 128 (8.8)
Analysis of adverse events associated with sedatives
Variable Value
Patient number 82
Age (yr) 5.2±5.1
Male sex 42 (51.2)
Causative drugs
 Midazolam 34 (41.5)
 Chloral hydrate 29 (35.4)
 Ketamine 14 (17.1)
 Others 5 (6.1)
Clinical manifestations
 Respiratory 31 (31.5)
 Gastrointestinal 13 (15.3)
 Skin 10 (11.8)
 Neuropsychiatric 8 (9.4)
 Cardiovascular 6 (7.1)
 Generalized 3 (3.5)
 Others 14 (16.5)

Values are presented as mean±standard deviation or number of patients (%).