Evidence map›Paper›PMID 40736538›Full record

ArticleNaunyn-Schmiedeberg's archives of pharmacology2026

Higher risk of gastrointestinal stenosis and obstruction in clozapine-treated individuals with schizophrenia: a pharmacovigilance study based on the FDA adverse event reporting system database.

Dandan Li, Zilong Zhao, Zhenhui Chen, Zhenzhen Qiao, Yao He, Jianxing Zhou, Xiaoyuan Zheng

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In one paragraph

Article in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

7 authors.

Dandan Li *Pharmacy Department, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Medical College, Chongqing University, Chongqing, China.
Zilong Zhao *Pharmacy Department, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Medical College, Chongqing University, Chongqing, China.
Zhenhui ChenDepartment of Pharmacy, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China.
Zhenzhen QiaoPharmacy Department, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Medical College, Chongqing University, Chongqing, China.
Yao HePharmacy Department, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Medical College, Chongqing University, Chongqing, China.
Jianxing ZhouDepartment of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. zhoujianxing@fjmu.edu.cn.
Xiaoyuan ZhengPharmacy Department, Chongqing Emergency Medical Center, Chongqing University Central Hospital, Medical College, Chongqing University, Chongqing, China. XiaoyuanZheng20@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClozapine, the most effective antipsychotic for treatment-resistant schizophrenia, is associated with severe adverse drug reactions (ADRs), including gastrointestinal stenosis and obstruction (GSO). Despite its efficacy, clozapine's anticholinergic properties impair gastrointestinal motility, leading to underrecognized yet life-threatening complications. This study investigates the risk of GSO in clozapine-treated individuals using real-world pharmacovigilance data.

methodsA retrospective analysis of the FDA Adverse Event Reporting System database (2013-2024) identified clozapine-related GSO cases. Disproportionality analysis used Reporting Odds Ratio (ROR) and Information Component (IC), with positive signals requiring both IC

resultsAmong 97,101 clozapine reports, 8021 involved gastrointestinal ADRs, with GSO showing strong disproportionality signals (ROR

conclusionClozapine significantly elevates GSO risk, with delayed onset and polypharmacy exacerbating toxicity. Findings underscore the need for enhanced gastrointestinal monitoring in long-term clozapine users and reevaluation of co-prescribing practices to mitigate this underprioritized ADR.

Indexed as

Antipsychotic AgentsClozapineGastrointestinal DiseasesIntestinal ObstructionSchizophreniaSchizophrenia, Treatment-ResistantAdultAdverse Drug Reaction Reporting SystemsAgedConstriction, PathologicDatabases, FactualFemaleHumansMaleMiddle AgedPharmacovigilanceAntipsychotic AgentsClozapineClozapineDrug safetyFAERS databaseGastrointestinal stenosis and obstructionPharmacovigilance

Identifiers

PMID40736538

What OpenQuestion holds

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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.