ArticleDrug safety2017
Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
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Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Pooled it
- Place of the partial dopamine receptor agonist aripiprazole in the management of schizophrenia in adults: a Delphi consensus study.BMC psychiatry · 2022Pooled it
- [Antipsychotics during pregnancy: a systematic review].Der Nervenarzt · 2021Pooled it
- Risk of Major Congenital Malformations Associated With the First-Trimester Exposure to Antipsychotics: A Large Claims Database Study.Pharmacology research & perspectives · 2026Article
- Safety of belimumab during pregnancy: associations with maternal and fetal or newborn adverse outcomes based on FAERS data.Therapeutic advances in drug safety · 2026Article
- Dopamine Partial Agonists in Pregnancy and Lactation: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2025Review
- A disproportionality analysis of low molecular weight heparin in the overall population and in pregnancy women using the FDA adverse event reporting system (FAERS) database.Frontiers in pharmacology · 2024Article
- Safety Profile of Aripiprazole During Pregnancy and Lactation: Report of 2 Cases.Turk psikiyatri dergisi = Turkish journal of psychiatry · 2023Article
- Itraconazole Contaminated with Rilmazafone in Japan: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database.Drugs - real world outcomes · 2022Article
- Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases.Drugs - real world outcomes · 2022Article
- Potential safety signal of pregnancy loss with vascular endothelial growth factor inhibitor intraocular injection: A disproportionality analysis using the Food and Drug Administration Adverse Event Reporting System.Frontiers in pharmacology · 2022Article
- Safety Profile of Antipsychotic Drugs: Analysis Based on a Provincial Spontaneous Reporting Systems Database.Frontiers in pharmacology · 2022Article
- Adverse Drug Reaction Reports Regarding Abnormal Behavior After Oseltamivir Use in Children as Reported by Consumers or Healthcare Professionals.Patient preference and adherence · 2021Article
- Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database.Vaccines · 2020Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWith recent advances in medicines, many patients with schizophrenia have become able to conceive. One common second-generation antipsychotic given to patients with schizophrenia is aripiprazole. The label information of aripiprazole in Japan states that according to one case report "there is a report of miscarriage in clinical trial".
objectiveThe aim of this study was to evaluate the relationship between aripiprazole and miscarriage by conducting a disproportionality analysis of an adverse drug event report database.
methodsWe conducted a disproportionality analysis of second-generation antipsychotic exposure during pregnancy using the Japanese Adverse Drug Event Report database, which is a spontaneous reporting database in Japan. We investigated aripiprazole and other approved second-generation antipsychotics in Japan. In accordance with the previous report, we created a data set for analysis consisting of pregnancy-related reports.
resultsA potential signal for miscarriage was detected for aripiprazole [proportional reporting ratio: 2.39, χ
conclusionThrough our analysis of the Japanese Adverse Drug Event Report database, we found a potential signal for miscarriage for aripiprazole. Safety information on the use of aripiprazole during pregnancy is very limited. Therefore, we suggest that the potential signal detected in our analysis be explored further.
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Registered trials
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.