Evaluation of dystonia in children and adolescents treated with atomoxetine within the Truven MarketScan database: a retrospective cohort study

Expert Opin Drug Saf. 2018 May;17(5):467-473. doi: 10.1080/14740338.2018.1462333. Epub 2018 Apr 13.


Objective: Atomoxetine is a non-stimulant drug indicated for the treatment of attention-deficit/hyperactivity disorder in children aged ≥6 years, adolescents, and adults. In this retrospective cohort study, the incidence and risk of dystonia in children and adolescents treated with atomoxetine was compared to a propensity score-matched cohort of stimulant users.

Methods: Data between 1 January 2006 and 31 December 2014 from patients aged 6-17 years in the Truven Health Analytics MarketScan database were used to generate two cohorts of patients: (1) atomoxetine users and (2) stimulant (methylphenidates or amphetamines) users. A Cox proportional hazards regression model was used to compare incidence of dystonia across propensity score-matched cohorts.

Results: Of the 70,657 atomoxetine users, 70,655 users were propensity score-matched to a stimulant user. In the atomoxetine- and stimulant-treated cohorts, the crude incidence rates of dystonia were 54.9 (95% CI: 27.1-82.7) and 77.9 (95% CI: 49.1-106.8) per 100,000 person-years, respectively. The hazard ratio for occurrence of dystonia with atomoxetine use relative to stimulant use was 0.68 (95% CI: 0.36 - 1.28; P = 0.23).

Conclusion: In this large retrospective cohort study, there was no significant difference in incidence or risk of dystonia among patients treated with atomoxetine compared to stimulants.

Keywords: ADHD; Atomoxetine hydrochloride; attention deficit disorder with hyperactivity; cohort studies; dystonia; retrospective studies.

MeSH terms

  • Adolescent
  • Adrenergic Uptake Inhibitors / adverse effects*
  • Adrenergic Uptake Inhibitors / therapeutic use
  • Atomoxetine Hydrochloride / adverse effects*
  • Atomoxetine Hydrochloride / therapeutic use
  • Attention Deficit Disorder with Hyperactivity / drug therapy
  • Central Nervous System Stimulants / adverse effects*
  • Central Nervous System Stimulants / therapeutic use
  • Child
  • Cohort Studies
  • Databases, Factual
  • Dystonia / chemically induced*
  • Dystonia / epidemiology
  • Female
  • Humans
  • Incidence
  • Male
  • Propensity Score
  • Proportional Hazards Models
  • Retrospective Studies
  • Risk


  • Adrenergic Uptake Inhibitors
  • Central Nervous System Stimulants
  • Atomoxetine Hydrochloride