Paracetamol: scoping review on the safe dose and maximum permitted daily exposure limit

Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02542| Publicado em: 13/03/2026

Authors

  • Simone Sant Anna Souza Nunes Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0001-6452-766X
  • Luciene Oliveira Morais Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0002-9398-5675
  • Isabella Fernandes Delgado Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil Author https://orcid.org/0000-0003-0610-5324

DOI:

https://doi.org/10.22239/2317-269X.02542

Keywords:

Paracetamol, Scoping Review, Permitted Daily Exposure, Safety Dose

Abstract

Introduction: Paracetamol, also known as N-acetyl-p-aminophenol (APAP), has long been a widely used medication for pain management. The inadvertent toxicity associated with APAP poses a global concern. Objective: To investigate and critically evaluate the safety of the currently established dose of 4 g/day for paracetamol. To calculate the Permitted Daily Exposure (PDE) values for paracetamol. Method: A scoping review was performed according to the Joanna Briggs Institute (JBI), and the report was based on the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist. The calculation of PDE values for paracetamol was carried out in accordance with the guidelines provided by the European Medicines Agency (EMA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Results: The PDE value calculated for paracetamol was 51.1 mg/day. Characteristics such as female sex, fasting or malnutrition, alcohol abuse, age over 40 years, comorbidity, and drug interactions with phenytoin, isoniazid, and protease inhibitors such as ritonavir and zidovudine are factors that may contribute to APAP toxicity. Conclusions: Drugs containing paracetamol are safe when used within the dosage and posology recommended of at most 4 g/day. Based on the data presented in this study, the following were identified as relevant risk factors for paracetamol toxicity: sex, diet, age, alcohol use, and drug interactions. The calculated PDE value for APAP is 51.1 mg/day. This implies that if an individual is consistently exposed to this daily dose throughout their lifetime, it is unlikely that any adverse effects will be observed.

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Author Biographies

  • Simone Sant Anna Souza Nunes, Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil
    icone_lattes.png https://lattes.cnpq.br/7802636874474518
  • Luciene Oliveira Morais, Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil

    icone_lattes.png https://lattes.cnpq.br/1850633828674142

  • Isabella Fernandes Delgado, Programa de Pós-graduação em Vigilância Sanitária, Instituto Nacional de Controle de Qualidade em Saúde/Fundação Oswaldo Cruz (INCQS/Fiocruz), Rio de Janeiro, RJ, Brasil

    icone_lattes.png https://lattes.cnpq.br/3335804315684184

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Published

2026-03-13

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How to Cite

Paracetamol: scoping review on the safe dose and maximum permitted daily exposure limit: Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02542| Publicado em: 13/03/2026. (2026). Health Surveillance under Debate: Society, Science & Technology , 14, 1-11. https://doi.org/10.22239/2317-269X.02542

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