Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database.

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Title: Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database.
Authors: Liu, Jinhua, Xue, Liping, Zeng, Fanxiang, Liu, Ying, Zhu, Yanting, Zhou, Jintuo, Zhang, Jinhua, Chen, Huajiao
Source: European Child & Adolescent Psychiatry. Aug2025, Vol. 34 Issue 8, p2585-2597. 13p.
Subjects: Atomoxetine, Self-injurious behavior, Risk assessment, Pharmacology, Attention-deficit hyperactivity disorder, Suicidal ideation, Drug side effects, Research funding, Logistic regression analysis, Multivariate analysis, Descriptive statistics, Methylphenidate, Confidence intervals, Data analysis software, Children
Abstract: This study aims to investigate the potential correlation between commonly prescribed attention-deficit/hyperactivity disorder (ADHD) medications and suicidal or self-injurious behaviors (SSIBs) among the pediatric population by exploring the FDA Adverse Event Reporting System (FAERS) database. The FAERS database (2004Q1–2023Q4) was queried and SSIBs cases associated with stimulants (methylphenidate, and amphetamine) or atomoxetine were identified. The signals for SSIBs were analyzed using disproportionate methods, and the accuracy of the results was validated through sensitivity analysis with multifactor logistic regression. Time-to-onset analysis explored factors affecting SSIBs manifestation. Disproportionality analysis revealed a significant negative association between methylphenidate and SSIBs, while atomoxetine exhibited a significant positive correlation with SSIBs. The frequency of SSIBs was lower with stimulants alone or with the combined use of stimulants and atomoxetine compared to atomoxetine alone. Time-to-onset analysis indicated that all cases were of the early failure type, with the median time to onset of SSIBs associated with atomoxetine occurring later than that linked to stimulants. Stratification by age showed that in the stimulant group, the median time to SSIBs was longer for patients aged 13–17 years compared to those aged 6–12 years. Conversely, the opposite trend was observed in the atomoxetine group. The observed differences in time to onset highlight the importance of individualized screening for SSIBs across various populations, ultimately improving patient outcomes in the follow-up of stimulants or atomoxetine recipients. [ABSTRACT FROM AUTHOR]
Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database.
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  Data: <searchLink fieldCode="AR" term="%22Liu%2C+Jinhua%22">Liu, Jinhua</searchLink><br /><searchLink fieldCode="AR" term="%22Xue%2C+Liping%22">Xue, Liping</searchLink><br /><searchLink fieldCode="AR" term="%22Zeng%2C+Fanxiang%22">Zeng, Fanxiang</searchLink><br /><searchLink fieldCode="AR" term="%22Liu%2C+Ying%22">Liu, Ying</searchLink><br /><searchLink fieldCode="AR" term="%22Zhu%2C+Yanting%22">Zhu, Yanting</searchLink><br /><searchLink fieldCode="AR" term="%22Zhou%2C+Jintuo%22">Zhou, Jintuo</searchLink><br /><searchLink fieldCode="AR" term="%22Zhang%2C+Jinhua%22">Zhang, Jinhua</searchLink><br /><searchLink fieldCode="AR" term="%22Chen%2C+Huajiao%22">Chen, Huajiao</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22European+Child+%26+Adolescent+Psychiatry%22">European Child & Adolescent Psychiatry</searchLink>. Aug2025, Vol. 34 Issue 8, p2585-2597. 13p.
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  Data: <searchLink fieldCode="DE" term="%22Atomoxetine%22">Atomoxetine</searchLink><br /><searchLink fieldCode="DE" term="%22Self-injurious+behavior%22">Self-injurious behavior</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmacology%22">Pharmacology</searchLink><br /><searchLink fieldCode="DE" term="%22Attention-deficit+hyperactivity+disorder%22">Attention-deficit hyperactivity disorder</searchLink><br /><searchLink fieldCode="DE" term="%22Suicidal+ideation%22">Suicidal ideation</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+side+effects%22">Drug side effects</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Logistic+regression+analysis%22">Logistic regression analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Multivariate+analysis%22">Multivariate analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Methylphenidate%22">Methylphenidate</searchLink><br /><searchLink fieldCode="DE" term="%22Confidence+intervals%22">Confidence intervals</searchLink><br /><searchLink fieldCode="DE" term="%22Data+analysis+software%22">Data analysis software</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: This study aims to investigate the potential correlation between commonly prescribed attention-deficit/hyperactivity disorder (ADHD) medications and suicidal or self-injurious behaviors (SSIBs) among the pediatric population by exploring the FDA Adverse Event Reporting System (FAERS) database. The FAERS database (2004Q1–2023Q4) was queried and SSIBs cases associated with stimulants (methylphenidate, and amphetamine) or atomoxetine were identified. The signals for SSIBs were analyzed using disproportionate methods, and the accuracy of the results was validated through sensitivity analysis with multifactor logistic regression. Time-to-onset analysis explored factors affecting SSIBs manifestation. Disproportionality analysis revealed a significant negative association between methylphenidate and SSIBs, while atomoxetine exhibited a significant positive correlation with SSIBs. The frequency of SSIBs was lower with stimulants alone or with the combined use of stimulants and atomoxetine compared to atomoxetine alone. Time-to-onset analysis indicated that all cases were of the early failure type, with the median time to onset of SSIBs associated with atomoxetine occurring later than that linked to stimulants. Stratification by age showed that in the stimulant group, the median time to SSIBs was longer for patients aged 13–17 years compared to those aged 6–12 years. Conversely, the opposite trend was observed in the atomoxetine group. The observed differences in time to onset highlight the importance of individualized screening for SSIBs across various populations, ultimately improving patient outcomes in the follow-up of stimulants or atomoxetine recipients. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1007/s00787-025-02694-w
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      – Code: eng
        Text: English
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        PageCount: 13
        StartPage: 2585
    Subjects:
      – SubjectFull: Atomoxetine
        Type: general
      – SubjectFull: Self-injurious behavior
        Type: general
      – SubjectFull: Risk assessment
        Type: general
      – SubjectFull: Pharmacology
        Type: general
      – SubjectFull: Attention-deficit hyperactivity disorder
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      – SubjectFull: Suicidal ideation
        Type: general
      – SubjectFull: Drug side effects
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      – SubjectFull: Research funding
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      – SubjectFull: Logistic regression analysis
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      – SubjectFull: Multivariate analysis
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      – SubjectFull: Descriptive statistics
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      – SubjectFull: Methylphenidate
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      – SubjectFull: Confidence intervals
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      – SubjectFull: Data analysis software
        Type: general
      – SubjectFull: Children
        Type: general
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      – TitleFull: Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database.
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              Text: Aug2025
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