Safety of 80 antidepressants, antipsychotics, anti-attention-deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta-review of 78 adverse effects
Open accessAbstract
Mental disorders frequently begin in childhood or adolescence. Psychotropic medications have various indications for the treatment of mental disorders in this age group and are used not infrequently off‐label. However, the adverse effects of these medications require special attention during developmentally sensitive periods of life. For this meta‐review, we systematically searched network meta‐analyses and meta‐analyses of randomized controlled trials (RCTs), individual RCTs, and cohort studies reporting on 78 a priori selected adverse events across 19 categories of 80 psychotropic medications – including antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity disorder (ADHD) medications and mood stabilizers – in children and adolescents with mental disorders. We included data from nine network meta‐analyses, 39 meta‐analyses, 90 individual RCTs, and eight cohort studies, including 337,686 children and adolescents. Data on ≥20% of the 78 adverse events were available for six antidepressants (sertraline, escitalopram, paroxetine, fluoxetine, venlafaxine and vilazodone), eight antipsychotics (risperidone, quetiapine, aripiprazole, lurasidone, paliperidone, ziprasidone, olanzapine and asenapine), three anti‐ADHD medications (methylphenidate, atomoxetine and guanfacine), and two mood stabilizers (valproate and lithium). Among these medications with data on ≥20% of the 78 adverse events, a safer profile emerged for escitalopram and fluoxetine among antidepressants, lurasidone for antipsychotics, methylphenidate among anti‐ADHD medications, and lithium among mood stabilizers. The available literature raised most concerns about the safety of venlafaxine, olanzapine, atomoxetine, guanfacine and valproate. Nausea/vomiting and discontinuation due to adverse event were most frequently associated with antidepressants; sedation, extrapyramidal side effects, and weight gain with antipsychotics; anorexia and insomnia with anti‐ADHD medications; sedation and weight gain with mood stabilizers. The results of this comprehensive and updated quantitative systematic meta‐review of top‐tier evidence regarding the safety of antidepressants, antipsychotics, anti‐ADHD medications and mood stabilizers in children and adolescents can inform clinical practice, research and treatment guidelines.
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In an umbrella review, atomoxetine and lisdexamphetamine were associated with hypertension in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
Experimental — accuracy not yet measuredIn an umbrella review, atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, and modafinil were associated with significantly worse anorexia in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, clonidine and guanfacine were associated with sedation in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, atomoxetine, methylphenidate, and modafinil were associated with weight loss in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, guanfacine was associated with QT prolongation in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, lisdexamphetamine and guanfacine were associated with discontinuation due to adverse events in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, methylphenidate and guanfacine were associated with abdominal pain in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
In an umbrella review, d-amphetamine, lisdexamphetamine, methylphenidate, and modafinil were associated with insomnia in children and adolescents with mental disorders.
“Five medications for ADHD were associated with significantly worse anorexia (atomoxetine, d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), four with insomnia (d-amphetamine, lisdexamphetamine, methylphenidate, modafinil), three with weight loss (atomoxetine, methylphenidate, modafinil), two each with abdominal pain (methylphenidate, guanfacine), discontinuation due to adverse event (”
From The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder (2021) · cites this paper as Solmi et al., 2020
Antipsychotics and other psychotropic agents have adverse effects.
“adverse effects of antipsychotics 258,259 or other psychotropic agents”
From Preventive psychiatry: a blueprint for improving the mental health of young people (2021) · cites this paper as [258]
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- Authors
- Solmi, M., Fornaro, M., Ostinelli, E. G., Zangani, C., Croatto, G., Monaco, F., Krinitski, D., Fusar‐Poli, P., & Correll, C. U.
- Affiliations
- University of Padua (IT)
- Federico II University Hospital (IT)
- University of Milan (IT)
- Azienda Sanitaria Locale Salerno (IT)
- Integrierte Psychiatrie Winterthur (CH)
- King's College London (GB)
- Northwell Health (US)
- ORCID
- Venue
- World Psychiatry
- Publisher
- Wiley
- Published
- 2020-05-11
- Volume
- 19
- Issue
- 2
- Pages
- 214-232
- ISSN
- 1723-8617 (ISSN-L)
- 2051-5545
- PMC
- PMC7215080
- OpenAlex
- W3023958087
- Semantic Scholar
- 1ed0275ca024c3cb70307f9990c3984d3617f532
- Cited by
- 324
- References
- 199
- Citations by year
- 2026: 43 · 2025: 51 · 2024: 48 · 2023: 62 · 2022: 70 · 2021: 37 · 2020: 13
- FWCI
- 43.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- World Psychiatry (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- children and adolescents, antidepressants, antipsychotic drugs, ADHD medication, mood stabilizers, adverse drug reactions, escitalopram, fluoxetine, lurasidone, methylphenidate, lithium, valproic acid, off-label drug use, weight gain, sedation, extrapyramidal symptoms, anorexia, insomnia, nausea and vomiting
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