Efficacy and safety of atomoxetine in the treatment of ADHD in children and adolescents: a systematic review

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 6–16 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. Systematic Review Registration Identifier CRD420251152121.