Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review
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Abstract: Since the discovery of chlorpromazine (CPZ) in 1952, first-generation antipsychotics (FGAs) have revolutionized psychiatric care in terms of facilitating discharge from hospital and enabling large numbers of patients with severe mental illness (SMI) to be treated in the community. Second-generation antipsychotics (SGAs) ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders ( DSM ) categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed first. However, alongside with safety, efficacy should also be considered on a patient-tailored basis. Keywords: antipsychotics, side effects, tolerability, safety, psychosis, psychiatry
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Preliminary data indicate that community exercise can be beneficial and engaging for young people with mental illness, including those with severe conditions.
“However, preliminary data indicates community exercise can be beneficial and engaging for young people with mental illness, even for those with severe conditions.253,254”
From The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness (2019) · cites this paper as [253]
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Self-citationGómez, L., Stubbs, B., Ayala, S., Vancampfort, D., Gaughran, F., & Lally, J. (2016) · Current Osteoporosis Reports · doi:10.1007/s11914-016-0325-0 · Cited by 40 · see citing works
Self-citationWalker, N. F., Brinchmann, K., & Batura, D. (2015) · Neurourology and Urodynamics · doi:10.1002/nau.22851 · Cited by 39 · see citing works
Use of antipsychotics and risk of myocardial infarction: a systematic review and meta‐analysis
Yu, Z., Jiang, H., Shao, L., Zhou, Y., Shi, H., & Ruan, B. (2016) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12985 · Cited by 39 · see citing works
Hypothyroidism risk compared among nine common bipolar disorder therapies in a large US cohort
Lambert, C. G., Mazurie, A., Lauve, N., Hurwitz, N. G., Young, S. S., Obenchain, R. L., Hengartner, N., Perkins, D. J., Tohen, M. F., & Kerner, B. (2016) · Bipolar Disorders · doi:10.1111/bdi.12391 · Cited by 39 · see citing works
An investigation of economic costs of schizophrenia in two areas of China
Zhai, J., Guo, X., Chen, M., Zhao, J., & Su, Z. (2013) · International Journal of Mental Health Systems · doi:10.1186/1752-4458-7-26 · Cited by 38 · see citing works
Nocturnal enuresis with antipsychotic medication
Barnes, T. R. E., Drake, M. J., & Paton, C. (2012) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.111.095737 · Cited by 38 · see citing works
Fedorenko, O. Y., LOONEN, A. J. M., Lang, F., et al. (2014) · The International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyu098 · Cited by 37 · see citing works
Polcwiartek, C., Vang, T., Bruhn, C. H., Hashemi, N., Rosenzweig, M., & Nielsen, J. (2016) · Psychopharmacology · doi:10.1007/s00213-016-4411-x · Cited by 37 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- [224]De Hert M Vancampfort D Stubbs B Sabbe T Wildiers H Detraux J Antipsychotic treatment, prolactin, and breast tumorigenesis Psychiatr Danub 2016 28 3 243 254 27658833
Cited by
Sorted by citations
OECD (2021) · OECD Health Policy Studies · doi:10.1787/4ed890f6-en · Cited by 407 · see citing works
Evidence-based umbrella review of 162 peripheral biomarkers for major mental disorders
Carvalho, A. F., Solmi, M., Sanches, M., Machado, M. O., Stubbs, B., Ajnakina, O., Sherman, C., Sun, Y. R., Liu, C. S., Brunoni, A. R., et al. (2020) · Translational Psychiatry · doi:10.1038/s41398-020-0835-5 · Cited by 204 · see citing works
Self-citationVázquez, G. H., Bahji, A., Undurraga, J., Tondo, L., & Baldessarini, R. J. (2021) · Journal of Psychopharmacology · doi:10.1177/02698811211013579 · Cited by 95 · see citing works
Self-citationSolmi, M., Pigato, G., Kane, J. M., & Correll, C. (2018) · Drug Design Development and Therapy · doi:10.2147/dddt.s133205 · Cited by 88 · see citing works
Medical Management of Eating Disorders: An Update
Voderholzer, U., Haas, V., Correll, C. U., & Körner, T. (2020) · Current Opinion in Psychiatry · doi:10.1097/yco.0000000000000653 · Cited by 70 · see citing works
Self-citationCroatto, G., Vancampfort, D., Miola, A., Olivola, M., Fiedorowicz, J. G., Firth, J., Alexinschi, O., Gaina, M. A., Makkai, V., Soares, F. C., et al. (2023) · Molecular Psychiatry · doi:10.1038/s41380-022-01770-w · Cited by 66 · see citing works
Self-citationSolmi, M., Correll, C. U., Carvalho, A. F., & Ioannidis, J. P. A. (2018) · Epidemiology and Psychiatric Sciences · doi:10.1017/s204579601800032x · Cited by 44 · see citing works
Self-citationBajor, L. A., Balsara, C., & Osser, D. N. (2022) · Psychiatry Research · doi:10.1016/j.psychres.2022.114840 · Cited by 43 · see citing works
Effect of Brexpiprazole on Prolactin: An Analysis of Short- and Long-Term Studies in Schizophrenia
Ivkovic, J., Lindsten, A., George, V., Eriksson, H., & Hobart, M. (2019) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000979 · Cited by 41 · see citing works
Bai, B., Li, Y., Chen, X., Huang, J., Chen, Q., Du, X., Huang, C., & Yang, Y. (2025) · BMC Psychiatry · doi:10.1186/s12888-025-06783-7 · Cited by 15 · see citing works
- Authors
- Solmi, M., Murru, A., Pacchiarotti, I., Undurraga, J., Veronese, N., Fornaro, M., Stubbs, B., Monaco, F., Vieta, E., Seeman, M., Correll, C., & Carvalho, A.
- Affiliations
- University of Padua (IT)
- Hospital Clínic de Barcelona (ES)
- Universidad del Desarrollo (CL)
- New York State Psychiatric Institute (US)
- University of Toronto (CA)
- Northwell Health (US)
- ORCID
- Venue
- Therapeutics and Clinical Risk Management
- Publisher
- Informa UK Limited
- Published
- 2017-06
- Volume
- Volume 13
- Pages
- 757-777
- ISSN
- 1176-6336 (ISSN-L)
- 1178-203X
- PMC
- PMC5499790
- OpenAlex
- W2728473268
- Cited by
- 438
- References
- 285
- Citations by year
- 2026: 44 · 2025: 44 · 2024: 48 · 2023: 36 · 2022: 62 · 2021: 55 · 2020: 60 · 2019: 43 · 2018: 39 · 2017: 3 · 2016: 1
- FWCI
- 5.99
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Therapeutics and Clinical Risk Management (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion, other-oa)
- Research Portal (King's College London) (submittedVersion, cc-by-nc)
- Padua Research Archive (University of Padova) (submittedVersion, cc-by)
- Funders
- Pfizer
- AstraZeneca
- Sanofi
- Sunovion
- Ministerio de Ciencia e Innovación
- Centro de Investigación Biomédica en Red de Salud Mental
- Servier
- H. Lundbeck A/S
- Comisión Nacional de Investigación Científica y Tecnológica (ACT1414)
- National Institute of Mental Health
- Fondo Nacional de Desarrollo Científico y Tecnológico (ACT1414, 1160736)
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- antipsychotic drugs, typical antipsychotics, atypical antipsychotics, drug safety, tolerability, adverse effects, severe mental illness, extrapyramidal symptoms, weight gain, metabolic abnormalities, negative symptoms, cognitive impairment, chlorpromazine, clozapine, olanzapine, amisulpride, aripiprazole
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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