Abstract
Objectives: To identify and characterize adverse drug events (ADE) in children with medical complexity hospitalized in a tertiary teaching hospital in Brazil. Method: A retrospective medical record review using predefined triggers to identify ADE was conducted. A simple random sample of pediatric hospitalizations in 2016 was used. Events were assessed for causality and degree of harm. Statistical analysis included logistic regression to identify associated factors. Results: The sample comprised 133 hospitalizations, with a median age of 1.7 years and a predominance of males (52.6%). Thirty-one ADE were identified in 17 hospitalizations, corresponding to rates of 23.3 ADE per 100 hospitalizations and 19.7 ADEs per 1,000 patient-days. A total of 12.8% of patients experienced at least one ADE. The most frequent ADE were hemoptysis (22.6%), diarrhea (12.9%), and pruritus (12.9%). Antibacterials were the drug class most frequently implicated in ADE. Multiple regression analysis demonstrated an association between ADE detection and increasing age. Conclusion: ADE were identified in more than 10% of the population, highlighting the importance of pharmacotherapy monitoring in hospitalized children. The clinical profile of the population—comprising cystic fibrosis and neurological syndromes—as well as the high number of hospitalizations due to pneumonia, influenced the occurrence of ADE because of their relationship with the use of antimicrobials and central nervous system–acting drugs. These findings reinforce the importance of ADE monitoring for early detection, prevention, and mitigation of medication-related harm, thereby promoting greater medication safety.
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Adverse drug events in hospitalized children with medical complexity | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 24 February 2026 V1 Latest version Share on Adverse drug events in hospitalized children with medical complexity Authors : Simone Cristina Rodrigues de Carvalho Caetano 0000-0003-2071-672X [email protected] , Luiz Fernando Emidio da Silva , Lusiele Guaraldo , and Fabiola Giordani 0000-0003-2919-856X Authors Info & Affiliations https://doi.org/10.22541/au.177194358.87573992/v1 115 views 54 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Objectives: To identify and characterize adverse drug events (ADE) in children with medical complexity hospitalized in a tertiary teaching hospital in Brazil. Method: A retrospective medical record review using predefined triggers to identify ADE was conducted. A simple random sample of pediatric hospitalizations in 2016 was used. Events were assessed for causality and degree of harm. Statistical analysis included logistic regression to identify associated factors. Results: The sample comprised 133 hospitalizations, with a median age of 1.7 years and a predominance of males (52.6%). Thirty-one ADE were identified in 17 hospitalizations, corresponding to rates of 23.3 ADE per 100 hospitalizations and 19.7 ADEs per 1,000 patient-days. A total of 12.8% of patients experienced at least one ADE. The most frequent ADE were hemoptysis (22.6%), diarrhea (12.9%), and pruritus (12.9%). Antibacterials were the drug class most frequently implicated in ADE. Multiple regression analysis demonstrated an association between ADE detection and increasing age. Conclusion: ADE were identified in more than 10% of the population, highlighting the importance of pharmacotherapy monitoring in hospitalized children. The clinical profile of the population—comprising cystic fibrosis and neurological syndromes—as well as the high number of hospitalizations due to pneumonia, influenced the occurrence of ADE because of their relationship with the use of antimicrobials and central nervous system–acting drugs. These findings reinforce the importance of ADE monitoring for early detection, prevention, and mitigation of medication-related harm, thereby promoting greater medication safety. Supplementary Material File (pds-26-0181-file001.docx) Download 47.50 KB Information & Authors Information Version history V1 Version 1 24 February 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords adverse events drug monitoring drug-related side effects and adverse reactions pediatric hospital pharmacoepidemiology pharmacovigilance vulnerable populations Authors Affiliations Simone Cristina Rodrigues de Carvalho Caetano 0000-0003-2071-672X [email protected] Fundacao Oswaldo Cruz View all articles by this author Luiz Fernando Emidio da Silva Fundacao Oswaldo Cruz View all articles by this author Lusiele Guaraldo Fundacao Oswaldo Cruz View all articles by this author Fabiola Giordani 0000-0003-2919-856X Universidade Federal Fluminense View all articles by this author Metrics & Citations Metrics Article Usage 115 views 54 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Simone Cristina Rodrigues de Carvalho Caetano, Luiz Fernando Emidio da Silva, Lusiele Guaraldo, et al. Adverse drug events in hospitalized children with medical complexity. Authorea . 24 February 2026. 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