Adverse drug reactions deaths in Brazil




Drug-related side effects and adverse reactions; Patient safety; Mortality; Health information systems; Brazil.


Objective: To assess adverse drug reaction (ADR) mortality and the distribution of deaths in Brazil and its regions. Methodology: Exploratory time series study of ADR mortality in Brazil by searching for data contained in the Mortality Information System-DATASUS, during the period of 2000-2019. The International Classification of Diseases, 10th revision (ICD-10) was resorted, codes Y40 to Y59. ADR mortality rates were calculated according to sex, age and region of residence. Results: In the 20 years that were analyzed, 2003 (0.001%) ADR deaths were registered. The average ADR mortality rate in Brazil was 0.0516/100,000, ranging from 0.0342 to 0.0715/100,000. The Southeast Region had the highest average mortality rates in the researched period, followed by the South and Midwest Regions, while the lowest rates were found in the North Region. The frequency of deaths were higher in women, having the highest rates in the age group of 60 years and over. Conclusion: ADR deaths rates are increasing in Brazil with regional differences. The small number of records in the period demonstrates the need of raising awareness among health professionals about filling out death certificates when the cause of it is related to ADR.


ANVISA. Agência Nacional de Vigilância Sanitária (2009). Guia Regulatório-ANVISA. Glossário da Resolução RDC No 04/2009. Brasília.

ANVISA. Agencia Nacional de Vigilância Sanitária (2021). Notificações de Farmacovigilância, VIGIMED.

Auraaen, A., L. Slawomirski & N. Klazinga (2018), "The economics of patient safety in primary and ambulatory care: Flying blind", OECD Health Working Papers, No. 106, OECD Publishing, Paris.

Bénard-Laribière, A., Miremont-Salamé, G., Pérault-Pochat, M. C., Noize, P., Haramburu, F., & EMIR. Study Group on behalf of the French network of pharmacovigilance centres (2015). Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study. Fundamental & clinical pharmacology, 29(1), 106–111.

Bertoldi A. D., Pizzol T.S., Ramos L.R., Mengue S.S., Luiza V.L., Tavares N.U.L., Farias, M. R., Oliveira, M. A., & Arrais, P. S. D. (2016). Perfil sócio - demográfico dos usuários de medicamentos no Brasil: resultados da PNAUM 2014. Rev Saúde Pública, 50 Suppl 2:5s.

Brvar, M., Fokter, N., Bunc, M., & Mozina, M. (2009). The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department specialty. BMC clinical pharmacology, 9, 8.

Carrasco-Garrido, P., de Andrés, L. A., Barrera, V. H., de Miguel, G. A., & Jiménez-García, R. (2010). Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006). BMC health services research, 10, 287.

Cheng, Y., Raisch, D. W., Borrego, M. E., & Gupchup, G. V. (2013). Economic, clinical, and humanistic outcomes (ECHOs) of pharmaceutical care services for minority patients: a literature review. Research in social & administrative pharmacy: RSAP, 9(3), 311–329.

Correr, C. J., Otuki, M. F., & Soler, O. (2011). Assistência farmacêutica integrada ao processo de cuidado em saúde: gestão clínica do medicamento. Revista Pan-Amazônica de Saúde, 2(3), 41-49.

Classen, D. C., & Metzger, J. (2003). Improving medication safety: the measurement conundrum and where to start. International journal for quality in health care: journal of the International Society for Quality in Health Care, 15 Suppl 1, i41–i47.

Edwards, I. R., & Aronson, J. K. (2000). Adverse drug reactions: definitions, diagnosis, and management. Lancet (London, England), 356(9237), 1255–1259.

Gonçalves, S. T., Louro, E., Pedroso, R. B., Soares, A. L. P. P. de P., & Cuman, R. K. N. (2021). Injúria Hepática Induzida por Medicamentos em Pacientes Hospitalizados. Research, Society and Development, 10(16), e70101623236.

IBGE. Instituto Brasileiro de Geografia e Estatística (2020). IBGE divulga o rendimento domiciliar per capita 2020.

Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 279(15), 1200–1205.

Martins, A. C., Giordani, F., Guaraldo, L., Tognoni, G., & Rozenfeld, S. (2018). Adverse drug events identified in hospitalized patients in Brazil by International Classification of Diseases (ICD-10) code listings. Cadernos de saude publica, 34(12), e00222417.

OPAS. Organização Pan-Americana da Saúde (2011). Boas práticas de farmacovigilância para as Américas. OPAS. Rede PAHRF Documento Técnico No 5. Washington, D.C.

Patel, T. K., & Patel, P. B. (2018). Mortality among patients due to adverse drug reactions that lead to hospitalization: a meta-analysis. European journal of clinical pharmacology, 74(6), 819–832.

Pirmohamed, M., James, S., Meakin, S., Green, C., Scott, A. K., Walley, T. J., Farrar, K., Park, B. K., & Breckenridge, A. M. (2004). Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ (Clinical research ed.), 329(7456), 15–19.

Porto, S., Marins, M., Mendes, W. & Travassos, C. (2010) A magnitude financeira dos eventos adversos em hospitais no Brasil. Rev Port Saúde Pública, (10):74-80.

Pouyanne, P., Haramburu, F., Imbs, J. L., & Bégaud, B. (2000). Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. French Pharmacovigilance Centres. BMJ (Clinical research ed.), 320(7241), 1036.

Santos, G., & Boing, A. C. (2018). Mortalidade e internações hospitalares por intoxicações e reações adversas a medicamentos no Brasil: análise de 2000 a 2014 [Hospitalizations and deaths from drug poisoning and adverse reactions in Brazil: an analysis from 2000 to 2014]. Cadernos de saude publica, 34(6), e00100917.

Shepherd, G., Mohorn, P., Yacoub, K., & May, D. W. (2012). Adverse drug reaction deaths reported in United States vital statistics, 1999-2006. The Annals of pharmacotherapy, 46(2), 169–175.

Silva, L. T., Modesto, A., Amaral, R. G., & Lopes, F. M. (2022). Hospitalizations and deaths related to adverse drug events worldwide: Systematic review of studies with national coverage. European journal of clinical pharmacology, 78(3), 435–466.

van der Hooft, C. S., Sturkenboom, M. C., van Grootheest, K., Kingma, H. J., & Stricker, B. H. (2006). Adverse drug reaction-related hospitalisations: a nationwide study in The Netherlands. Drug safety, 29(2), 161–168.

Waller, P., Shaw, M., Ho, D., Shakir, S., & Ebrahim, S. (2005). Hospital admissions for 'drug-induced' disorders in England: a study using the Hospital Episodes Statistics (HES) database. British journal of clinical pharmacology, 59(2), 213–219.

Wester, K., Jönsson, A. K., Spigset, O., Druid, H., & Hägg, S. (2008). Incidence of fatal adverse drug reactions: a population based study. British journal of clinical pharmacology, 65(4), 573–579.

World Health Organization (2009). The conceptual framework for the international classification for patient safety. patientsafety/taxonomy/icps_full_report.pdf

WHOa. World Health Organization (2019). World Health Assembly 72. Patient Safety: global action on patient safety: report by the Director General. Geneva.

WHOb. World Health Organization (2019). 10 Facts on patient safety. Geneva. features/factfiles/patient_safety/en/

Wu, T. Y., Jen, M. H., Bottle, A., Molokhia, M., Aylin, P., Bell, D., & Majeed, A. (2010). Ten-year trends in hospital admissions for adverse drug reactions in England 1999-2009. Journal of the Royal Society of Medicine, 103(6), 239–250.



How to Cite

LOURO, E.; DUTRA, A. de C. .; GONÇALVES, S. T. .; MARQUES, V. D.; TAKAKI, I. .; OLIVEIRA, R. R. de .; PEDROSO, R. B. .; CUMAN, R. K. N. Adverse drug reactions deaths in Brazil. Research, Society and Development, [S. l.], v. 11, n. 6, p. e29911627897, 2022. DOI: 10.33448/rsd-v11i6.27897. Disponível em: Acesso em: 28 may. 2022.



Health Sciences