Category: Pediatric Movement Disorders
Objective: To further explore the safety profile of dopamine D2 receptor antagonists (D2RAs) for Tourette syndrome (TS) in a community setting.
Background: D2RAs (aripiprazole/haloperidol/pimozide) are indicated for the treatment of TS. However, they are associated with adverse events (AEs; eg, weight gain, dyslipidemia, extrapyramidal symptoms). Non-D2RA medications are frequently administered to treat tics, but such use is off-label.
Method: This was a retrospective health records database (TriNetX Dataworks-USA Network) analysis. The D2RA cohort was indexed on the first D2RA record (2011-2021) with prior TS diagnosis (ICD-9:307.23/ICD-10:F95.2); the non-D2RA cohort was indexed on a randomly selected record with TS diagnosis (2011-2021). Additional criteria were age 6-17 years, ≥1 provider encounter during a baseline period (≥18 months prior to index date), and an 18-month follow-up period. Individuals in each cohort were exact-matched based on age group, index year, region, and sex. Incident AEs were identified based on a combination of diagnosis codes, anthropometric measurements, and laboratory results, and categorized according to type (eg, neurological/metabolic/cardiac) and severity (eg, sleep disorder [mild]; dystonia [moderate]; tardive dyskinesia [severe]).
Results: 1684 matched individuals were included in each cohort (median age, 13 years; male, 73.9%). Individuals treated with D2RAs compared with those in the non-D2RA cohort were more likely to experience multiple types of AEs across several categories: mild metabolic events (16.2% vs 3.9%), moderate metabolic events (3.7% vs 0.6%), sleep disorders (7.7% vs 2.4%), depression (6.3% vs 2.7%), OCD (6.2% vs 2.6%), and suicidal ideation/behavior/attempts (4.2% vs 1.1%). In the D2RA group, dystonia, akathisia, and tardive dyskinesia were reported in 8 (0.5%), 3 (0.2%), and 1 (0.06%) individuals, respectively; none of these were reported in the non-D2RA cohort.
Conclusion: In a real-world health care setting, children with TS treated with D2RAs were more likely to experience multiple metabolic and neuropsychiatric AEs versus non-exposed individuals. These findings highlight the need for safer TS treatment options.
To cite this abstract in AMA style:
K. Tomczak, J. Swindle, F. Dabbous, G. Karkanias, S. Atkinson, F. Munschauer, F. Mazhar, C. Pettersson, S. Wanaski, T. Cunniff, D. Isaacs. Real-World Adverse Event Profile in Children and Adolescents With Tourette Syndrome Treated With Dopamine D2 Receptor Antagonists (D2RAs) Compared With Non-D2RAs [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/real-world-adverse-event-profile-in-children-and-adolescents-with-tourette-syndrome-treated-with-dopamine-d2-receptor-antagonists-d2ras-compared-with-non-d2ras/. Accessed October 5, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-adverse-event-profile-in-children-and-adolescents-with-tourette-syndrome-treated-with-dopamine-d2-receptor-antagonists-d2ras-compared-with-non-d2ras/