SYSTEMATIC REVIEW article
Front. Child Adolesc. Psychiatry
Sec. Child Mental Health and Interventions
Efficacy and Safety of Atomoxetine in the Treatment of ADHD in Children and Adolescents: A Systematic Review
Provisionally accepted
Edmundo Alberto Barbosa Bastos De Souza Neto1*
Halley Ferraro Oliveira1
William Santos Ramos2Estelio Henrique Martin Dantas1Barbara Hellen Alves Pereira3Rebeca de Souza Mariano Bastos4- 1Tiradentes University, Aracaju, Brazil
- 2Independent Researcher, Aracaju, Brazil
- 3Universidade Brasil, São Paulo, Brazil
- 4Hospital de Urgências de Sergipe Governador João Alves Filho, Aracaju, Brazil
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Objective: To evaluate the efficacy and safety of atomoxetine in the treatment of adolescents with ADHD, comparing its effects with other available treatments. The primary outcome was the reduction of ADHD symptoms, and the secondary outcome was the occurrence of adverse effects. Methods: A search was conducted in the Medline/PubMed, EMBASE, and Web of Science databases. The research question and strategy were based on the PICO model. Inclusion criteria were restricted to studies involving children and adolescents aged 6 to 16 years, focusing on comparisons between atomoxetine and other treatments. Eligible studies were published in English, Spanish, or Portuguese, with no restrictions on publication year. A total of 575 articles were initially retrieved. After removing duplicates, 527 references were screened by title and abstract, and 69 were selected for full-text review. Following this stage, 63 references were excluded, and 6 studies were ultimately deemed eligible. Results: The six included studies involved a total of 905 participants. Atomoxetine demonstrated comparable efficacy to methylphenidate in reducing ADHD symptoms. The most common adverse effects were nausea, fatigue, and appetite changes. No severe adverse events were consistently reported. Atomoxetine's efficacy was particularly evident in patients who did not tolerate or respond to stimulant medications. Conclusion: Available evidence suggests that atomoxetine is an effective and safe option for treating ADHD in adolescents, representing a valid alternative particularly for patients who do not tolerate stimulant medications. Continued research, especially long-term studies, is necessary to confirm its efficacy across different patient subgroups.
Keywords: ADHD, adolescents, atomoxetine, Safety, efficacy, pharmacological treatment, adverse effects
Received: 23 Oct 2025; Accepted: 29 Nov 2025.
Copyright: © 2025 Barbosa Bastos De Souza Neto, Oliveira, Santos Ramos, Martin Dantas, Alves Pereira and de Souza Mariano Bastos. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Edmundo Alberto Barbosa Bastos De Souza Neto
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