Evidence map›Paper›PMID 40259575›Full record

ArticleOral diseases2025

Oral Adverse Effects of Antipsychotic Medications: A Case/Noncase Analysis of EudraVigilance Data.

Leire Urien, Unax Lertxundi, Montserrat Garcia, Carmelo Aguirre, Nerea Jauregizar, Teresa Morera-Herreras

Abstract read
In one paragraph

Article in Oral diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
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  5. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Leire UrienDepartment of Pharmacology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.ORCID https://orcid.org/0000-0002-8942-8294
Unax LertxundiBioaraba Health Research Institute; Osakidetza Basque Health Service, Araba Mental Health Network, Araba Psychiatric Hospital, Pharmacy Service, Vitoria-Gasteiz, Spain.ORCID https://orcid.org/0000-0002-9575-1602
Montserrat GarciaBiobizkaia Health Research Institute, Osakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Galdakao, Spain.ORCID https://orcid.org/0000-0001-7026-1079
Carmelo AguirreDepartment of Pharmacology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.ORCID https://orcid.org/0000-0003-3555-1550
Nerea JauregizarDepartment of Pharmacology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.ORCID https://orcid.org/0000-0002-8738-0901
Teresa Morera-HerrerasDepartment of Pharmacology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.ORCID https://orcid.org/0000-0002-7601-4914

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveNeuropsychiatric disorders are associated with poor oral health, with antipsychotics as potential contributors. This study aimed to analyse the oral adverse effects of antipsychotics using the EudraVigilance database.

methodsA case/noncase analysis was conducted to calculate reporting odds ratios (ROR) and assess the disproportionality of oral adverse events.

resultsA total of 5663 reports of oral adverse effects related to antipsychotics were identified. Atypical antipsychotics had a higher overall incidence (5663 vs. 787 for typical), but typical antipsychotics showed stronger associations with specific oral issues (ROR = 2.2 vs. 1.6 for atypical). The most commonly reported effects were disturbances in salivary flow, including xerostomia and hypersalivation. Olanzapine and quetiapine were linked to dry mouth (ROR = 1.8 and 3.0) and tooth loss (ROR = 1.7 and 1.8). Clozapine had the highest number of reports (1619) and ROR (33.1) for hypersalivation. Disproportionality analysis revealed significant associations with orofacial dyskinesia for all antipsychotics, except clozapine. Aripiprazole had the highest ROR (13.7) for orofacial dyskinesia and was linked to a swollen tongue in patients aged ≤ 17 years (12 cases, ROR = 3.6). No sex-based differences were identified.

conclusionsAntipsychotics significantly affect oral health, highlighting the need for preventive dental care and interventions to reduce these effects and improve patient well-being.

Indexed as

Antipsychotic AgentsMouth DiseasesAdolescentAdultAgedDatabases, FactualFemaleHumansMaleMiddle AgedQuetiapine FumarateSialorrheaXerostomiaYoung AdultAntipsychotic AgentsQuetiapine Fumarateatypical antipsychoticsdrug‐related side effectsEudraVigilanceoral healthpharmacovigilancetypical antipsychotics

Identifiers

PMID40259575
PMCPMC12423477

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.