Adverse drugs reactions in pediatric patients: clinical profile and monitoring of outcomes
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02366| Published on: 25/03/2026
DOI:
https://doi.org/10.22239/2317-269X.02366Keywords:
Adverse Drug Reactions, Adverse Events in Childhood, Drug Toxicity, PharmacovigilanceAbstract
Introduction: Due the changes that occur during the immaturity of the physiological system involved in pediatric pharmacokinetic and pharmacodynamic processes and the use of adaptations of adult formulations, the occurrence of adverse reactions to medications can be frequent. Objective: This study seeks to analyze the occurrence profile of suspected cases of adverse drug reactions in a pediatric hospital. Method: This is a retrospective cross-sectional study, in which records from a database containing information on suspected cases of adverse drug reactions were analyzed from April 2021 to December 2023 from an active search. Results: 240 suspected cases of adverse drug reactions were identified. Most ADR manifestations were in hospitalized patients, 205 (85.4%), and the sector that leads in the number of cases is the oncology clinic, 85 (35.4%). As for the patient profile, the most frequent are males, 130 (54.2%), and the age group is between 5 and 10 years old, 77 (32.1%). Among the classes that cause ADRs, the most cited were antibiotics, 84 (35.0%). The clinical manifestations reported in greater numbers were those related to the integumentary and digestive systems. Conclusions: Through the data obtained, it is possible to see the importance of knowing these reactions as well as their management by the multidisciplinary team and how much a pharmacovigilance service can contribute to patient safety in the hospital environment.
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Author Biographies
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Herculana Neta Gomes de Oliveira dos Santos, Hospital Martagão Gesteira-LABCMI-HMG
Graduated in Pharmacy from the State University of Bahia in 2022. Active as a teaching monitor in the Pharmaceutical Chemistry discipline. She was part of the Academic League of Medicinal Plants and Phytotherapeutics. She has experience in Hospital Pharmacy through the Multiprofessional Residency in Child and Adolescent Health at Hospital Martagão Gesteira from 2022 to 2024.
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Rosa Malena Fagundes Xavier, Universidade do Estado da Bahia (UNEB), Salvador, BA, Brasil
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Thainan Cristine Lima Santos, Hospital Martagão Gesteira (HMG), Salvador, BA, Brasil
References
1. Albergaria TFS, Motta PCV, Bouzas MLSB. Manual de Fisioterapia pediátrica. Salvador: Sanar; 2019.
2. Barros DSL. Medicamentos não licenciados: uma discussão em pediatria. Res Soc Develop. 2020;9(10):1-14.https://doi.org/10.33448/rsd-v9i10.9262
3. Vieira JML, Lima EC, Land MDP, Ventura M, Coelho HLL. Perfil dos ensaios clínicos envolvendo crianças brasileiras. Cad Saúde Pública. 2017;33(5):1-11.https://doi.org/10.1590/0102-311X00169515
4. Agência Nacional de Vigilância Sanitária – Anvisa. Resolução RDC Nº 9, de 20 de fevereiro de 2015. Dispõe sobre o regulamento para a realização de ensaios clínicos com medicamentos no Brasil. Diário Oficial União.3 mar 2015.
5. Barros ES, Albuquerque RS, Bezerra LTCN, Lúcio IML, Neves SJF. Uso off-label de medicamentos em pediatria: uma revisão integrativa em ambientes hospitalares. Rev Recien. 2025;15(43):233-43.https://doi.org/10.24276/rrecien2025.15.43.233
6. Ministério da Saúde (BR). Assistência farmacêutica em pediatria no Brasil: recomendações e estratégias para a ampliação da oferta, do acesso e do uso racional de medicamentos em criança. Brasília: Ministério da Saúde; 2017.
7. Diel JAC, Heineck I, Santos DB, Pizzol TSD. Uso off-label de medicamentos segundo a idade em crianças brasileiras: um estudo populacional. Rev Bras Epidemiol. 2020;23:E200030.https://doi.org/10.1590/1980-549720200030
8. Modesto ACF, Ferreira TXAM, Provin MP, Amaral RG, Lima DM. Reações adversas a medicamentos e farmacovigilância: conhecimentos e condutas de profissionais de saúde de um hospital da rede sentinela. Rev Bras Educ Med. 2016;40(3):401-10.https://doi.org/10.1590/1981-52712015v40n3e01502015
9. Melo JRR, Duarte CD, Arrais PSD. Notificação de eventos adversos de medicamentos no Brasil: perfil dos profissionais que notificam ao sistema de farmacovigilância brasileiro. Cad Saúde Pública. 2025;37(11):1-3.https://doi.org/10.1590/0102-311X00237221
10. Lima TC, Almeida PP, Resende DGO. Avaliação das notificações de reações adversas a medicamentos em um hospital público de Minas
Gerais. Vigil Sanit Debate. 2021;9(4):57-65.https://doi.org/10.22239/2317-269x.01924.
11. Agrizzi AL, Castilho SR. Administração e gestão da assistência farmacêutica- metodologia trigger tool na detecção de eventos adversos a medicamentos. Niterói:Universidade Federal Fluminense; 2018.
12. Zangirolami-Raimundo J, Echeimberg JO, Leone C. Tópicos de metodologia de pesquisa: estudos de corte transversal. J Hum Growth Dev. 2018;28(3):356-60.https://doi.org/10.7322/jhgd.152198
13. Molinari JV, Cancelier ACL, Schuelter-Treviso F. Uso de medicamentos em crianças internadas em hospital do Sul do Brasil 2016-2017. Rev Amrigs. 2019;63(1):15-2.
14. Bouvy JC, Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015;38(5):437-53.https://doi.org/10.1007/s40264-015-0281-0
15. Adade CA, Xeque A, Mefetah H, Kili A, Hessissen L, Bouatia M. Adverse effects of anticancer chemotherapy in childhood cancer: A prospective study in a Moroccan hospital. Res J Pharm Technol. 2022;15(6):2559-64.https://doi.org/10.52711/0974-360X.2022.00428
16. Gupta S, Zaki SA, Masavkar S, Shanbag P. Causality, severity, and avoidability of adverse drug reactions in hospitalized children: a prospective cohort study. Cureus. 2023;15(1).https://doi.org/10.7759/cureus.33369
17. Grunewald STF, Aroeira IP, Paiva LM, Rossi MAP. Análise do perfil clínico e demográfico da enfermaria pediátrica de um Hospital Universitário. Res Ped. 2019;9(1):19-22. https://doi.org/10.25060/residpediatr
18. Tripathy R, Das S, Das P, Mohakud NK, Das M. Adverse drug reactions in the pediatric population: findings from the adverse drug reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020). Cureus. 2021;13(11):1-7.https://doi.org/10.7759/cureus.19424
19. Cazé MO, Rocha BSD, Santos MT, Machado FR, Fumegalli G, Locatelli DL et al. Reações adversas a medicamentos em unidade de oncologia pediátrica de hospital universitário. Rev Bras Farm Hosp Serv Saúde. 2015;6(3):34-8.
20. Sharma PK, Misra AK, Gupta N, Khera D, Gupta A, Khera P. Pediatric pharmacovigilance in an institute of national importance: journey has just begun. Indian J Pharmacol. 2017;49(5):390-5.https://doi.org/10.4103/ijp.IJP_256_17
21. Lima EC, Matos GC, Vieira JM, Gonçalves ICCR, Cabral LM, Turner MA. Suspected adverse drug reactions reported for Brazilian children:cross-sectional study.J Ped. 2019;95(6):682-8.https://doi.org/10.1016/j.jped.2018.05.019
22. Nakamura T, Wakiguchi H, Okazaki F, Asano N, Hoshii Y, Hasegawa S. Purpuric drug eruption without leukocytoclastic vasculitis associated with vancomycin. Asian Pac J Allergy Immunol. 2020;38:47-51.https://doi.org/10.12932/AP-210518-0319
23. Alvarez-Arango S, Yerneni S, Tang O, Zhou L, Mancini CM, Blackley S et al. Vancomycin hypersensitivity reactions documented in electronic health records. J Allergy Clin Immun. 2021;9(2):906-12.https://doi.org/10.1016/j.jaip.2020.09.027
24. Tanoshima R, Khan A, Agnieszka KB, Trueman JN, Drögemöller BI, Wright GEB et al. Análises de reações adversas a medicamentos: rede nacional de vigilância ativa: rede canadense de farmacogenômica para banco de dados de segurança de medicamentos. J Farm Clín.2019;59(3):356-63.
25. Kloos RQH, Pieters R, Van Den Bos C, Van Eijkelenburg NKA, Jonge R, Van Der Sluis IM. O efeito da terapia com asparaginase na toxicidade e eficácia do metotrexato em crianças com leucemia linfoblástica aguda. Leuc Linf. 2019;60(12):3002-10.
26. Sous D, Armstrong AE, Huang JT, Shah S, Carlberg VM, Coughlin CC. Cutaneous reactions to pediatric cancer treatment part I: conventional chemotherapy. Ped Derm.2021;38(1):8-17. https://doi.org/10.1111/pde.14418
27. Dubrall D, Leitzen S, Toni I, Stingl J, Schulz M, Schmid M et al. Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs. BMC Pharmacol Toxicol. 2021;22(1):1-16.https://doi.org/10.1186/s40360-021-00520-y
28. Cliff-Eribo KO, Sammons H, Star K, Ralph Edwards I, Osakwe A, Choonara I. Adverse drug reactions in Nigerian children: a retrospective review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012. Paed Int Child Health. 2016;36(4):300-4.https://doi.org/10.1179/2046905515Y.0000000059
29. Sindhu AR, Sebastian M, Panicker PR, Muthusamy S, Nallasamy V, Ramanathan S et al. Um estudo sobre reações adversas a medicamentos em pacientes pediátricos hospitalizados em um hospital de cuidados terciários. J Appl Pharm Sci. 2019;9(9):72-6.
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O(s) autor(es) do presente manuscrito declaram que disponibilizam seus dados de pesquisa. Os autores poderão acessá-los através dos links do currículo lattes ou Orcid.
Herculana Neta Gomes de Oliveira dos Santos
CV: http://lattes.cnpq.br/2846476102490700
https://orcid.org/0009-0002-3111-306X
Email: lanagomes883@gmail.com
Rosa Malena Fagundes Xavier
CV: http://lattes.cnpq.br/7273889178217037
https://orcid.org/0000-0002-3203-8949
Email: rosamalenafagundesxavier@gmail.com
Thainan Cristine Lima Santos
http://lattes.cnpq.br/0605457084678677
https://orcid.org/0009-0003-1820-9232
Email: thainan.cristine@hotmail.com
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