Hallucinations and Other Psychotic Symptoms Associated With the Use of Attention-Deficit/Hyperactivity Disorder Drugs in Children
Abstract
Objectives To gain a better understanding of the capacity of psychostimulant medications to induce adverse psychiatric reactions and determine the frequency of such reactions, we analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or under development, for the treatment of attention-deficit/hyperactivity disorder. Methods The US Food and Drug Administration requested manufacturers of drugs approved for attention-deficit/hyperactivity disorder or with active clinical development programs for that indication to search their electronic clinical trial databases for cases of psychosis or mania using prespecified search terms. The manufacturers supplied descriptions of clinical trials, numbers of patients exposed to study drug, and duration of exposure to permit calculations of incidence rates. Independently, cases of psychosis or mania in children and adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug Administration Adverse Event Reporting System safety database were analyzed. Manufacturers were asked to conduct similar analyses of their postmarketing surveillance databases. Results We analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. A total of 11 psychosis/mania adverse events occurred during 743 person-years of double-blind treatment with these drugs, and no comparable adverse events occurred in a total of 420 person-years of p…
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An uncommon significant adverse effect of stimulants is the occurrence of hallucinations and other psychotic symptoms.
“An uncommon significant adverse effect of stimulants is the occurrence of hallucinations and other psychotic symptoms.111”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [111]
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- Authors
- Mosholder, A. D., Gelperin, K., Hammad, T. A., Phelan, K., & Johann-Liang, R.
- Affiliations
- United States Food and Drug Administration (US)
- Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland
- Corresponding author
- Gelperin, Kate
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2009-02-01
- Volume
- 123
- Issue
- 2
- Pages
- 611-616
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2092853583
- Cited by
- 155
- References
- 15
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 10 · 2023: 4 · 2022: 8 · 2021: 6 · 2020: 15 · 2019: 18 · 2018: 7 · 2017: 10 · 2016: 7 · 2015: 12 · 2014: 8 · 2013: 6 · 2012: 8
- FWCI
- 7.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- attention deficit hyperactivity disorder, psychostimulants, psychosis, mania, hallucinations, adverse drug reactions, drug safety in children, post-marketing surveillance, FDA Adverse Event Reporting System
- MeSH terms
- Attention Deficit Disorder with Hyperactivity, Child, Female, Hallucinations, Humans, Male, Psychoses, Substance-Induced, Adverse Drug Reaction Reporting Systems
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