# Systematic review: Safety and efficacy of atomoxetine in children and adolescents with autism spectrum disorder

## TL;DR

This review examines the safety and effectiveness of Atomoxetine for treating ADHD symptoms in children and adolescents with autism, finding it to be well-tolerated with few side effects.

## Contribution

The study provides a systematic review of Atomoxetine's use in ASD, highlighting its potential as a safe off-label treatment.

## Key findings

- Atomoxetine was found to be well tolerated and safe in pediatric patients with ASD.
- Atomoxetine response rates were similar to methylphenidate but with fewer adverse events.
- There is a need for more high-power studies to make conclusive recommendations.

## Abstract

This systematic review aimed to assess the current evidence on the efficacy and safety of Atomoxetine in common clinical attention‐deficit hyperactivity disorder (ADHD) symptoms in the context of autism spectrum disorder (ASD) for children and adolescents. Some of these common clinical symptoms of ADHD in the context of ASD include core symptoms of ASD, ADHD, depression, anxiety, mood instability/irritability, and cognitive symptoms.

Major medical literature were searched for randomized controlled trials (RCTs), open‐label trials, and other relevant studies or clinical trials reporting on pediatric (age <18 years) patients with ASD treated with Atomoxetine for any reason. Databases were searched January of 2024 and include PubMed, Google Scholar, Web of Science, Scopus, PsycINFO, and Embase. Exclusion criteria were unpublished data and multiple reports from the same data set.

A total of 100 abstracts were screened, and 16 clinical trials were selected for inclusion. Out of these 16 clinical trials there were two RCTs (n = 128 and 97), four open‐label trials (n = 24, 12, 12, and 16), eight extension studies (n = 128, 97, 88, 97, 97, 117, 128, and 94), one observational study (n = 4), and one crossover study (n = 16). Meta‐analysis was not performed due to a lack of homogeneity in the two RCTs. There were limited studies available with a need for more high‐power studies. In the current studies, most suggested that Atomoxetine was well tolerated and safe in pediatric patients with ASD. In fact, Atomoxetine response rates were found to be similar to those of methylphenidate in ASD studies, while inducing fewer adverse events and tolerated better.

Further trials are warranted to make conclusive recommendations on Atomoxetine for improvement of common clinical symptoms of ADHD in the ASD pediatric population. Given limited approved therapies for common clinical symptoms of ASD in children and adolescents, Atomoxetine could be used as a safe off‐label option due to a favorable tolerability profile and minimal adverse effects.

This systematic review aimed to assess the current evidence on the efficacy and safety of Atomoxetine in common clinical symptoms of autism spectrum disorder (ASD) for children and adolescents. With limited studies available, there is a need for more high‐power studies for the use of Atomoxetine in children and adolescents with autism spectrum disorder. However, given limited approved therapies for common clinical symptoms of ASD in children and adolescents, Atomoxetine could be used for a safe off‐label option due to a favorable tolerability profile and minimal adverse effects.