ArticleEClinicalMedicine2025
Exploring potential associations between GLP-1RAs and depressive disorders: a pharmacovigilance study based on FAERS and VigiBase data.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Burden and Risk of Depression in Patients Receiving Semaglutide: A Systematic Review and Meta-Analysis.Clinical obesity · 2026Pooled it
- Avoidance of cardiac toxicity during the application of immune checkpoint inhibitors: a safety systematic review combining network meta-analysis and pharmacovigilance study.Frontiers in immunology · 2026Pooled it
- Evaluating the Evolving Real-World Adverse Events of GLP-1RAs Using FDA Adverse Event Reporting System (FAERS).Obesity (Silver Spring, Md.) · 2026Article
- Adverse events associated with immune checkpoint inhibitors in combination with chemotherapy in lung cancer: a real-world analysis.Journal of thoracic disease · 2026Article
- Psychiatric Safety Signals of GLP-1 Receptor Agonists: A FAERS-Based Pharmacovigilance Study with Explainable Machine Learning.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Integrated Evidence from VigiBase and Clinical Trials: A Comprehensive Pharmacovigilance Analysis of Seven Glucagon-Like Peptide 1 Receptor Agonists (GLP-1 RAs).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Depression and Anxiety Among Individuals Receiving Incretin Mimetic Medications: A Saudi Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2026Article
- Engineered nutrient-stimulated hormonal multi-agonists for precision targeting of obesity and metabolic disorders.Clinical and molecular hepatology · 2026Review
- Drugs Associated with Pediatric Cataracts: A Real-World Pharmacovigilance Study.Children (Basel, Switzerland) · 2026Article
- Beyond glycemic control: Sex differences shaping glucagon-like peptide-1 receptor agonist utilization in the United States.Journal of managed care & specialty pharmacy · 2026Article
- Pharmacovigilance analysis of severe cutaneous adverse reactions associated with antiseizure medications: a FAERS database study with time-to-onset evaluation.Frontiers in pharmacology · 2026Article
- Review
- Cardiovascular adverse event reporting profile of tirzepatide: a real-world pharmacovigilance analysis of heart failure, arrhythmias, and ischemic events.Frontiers in pharmacology · 2026Article
- Risk of depression with GLP-1 receptor agonists use in overweight or obese adults with type 2 diabetes: A new-user, active-comparator cohort study.Diabetes, obesity & metabolism · 2026Article
- The Clinical Application of GLP-1RAs and GLP-1/GIP Dual Receptor Agonists Based on Pharmacological Mechanisms: A Review.Drug design, development and therapy · 2025Review
- Adverse events of the thyroid peroxidase inhibitor methimazole in the treatment of hyperthyroidism: a comprehensive analysis from the first quarter of 2004 to the first quarter of 2025.Frontiers in endocrinology · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: GLP-1 receptor agonists (GLP-1RAs) are increasingly prescribed for diabetes and obesity management. Recent pharmacovigilance reports have raised concerns about potential neuropsychiatric adverse events, yet comprehensive safety assessments focusing on depressive disorders remain limited. This study investigated associations between specific GLP-1RAs and depressive disorders using real-world post-marketing surveillance data. Methods: We analyzed individual case safety reports (ICSRs) for liraglutide, semaglutide, and tirzepatide from the FDA Adverse Event Reporting System (FAERS) and WHO VigiBase databases through December 2024. Disproportionality analysis using reporting odds ratio (ROR) and information component (IC) identified signals of disproportionate reporting (SDRs) for depressive disorders. Time-to-onset analysis, stratified analyses, active comparator assessments, and co-medication evaluations were conducted to characterize these associations. Findings: Only semaglutide demonstrated statistically significant SDRs for depressive disorders in both databases (FAERS: ROR 1.26, 95% confidence interval (CI) 1.15-1.37; IC 0.33, 95% CI 0.20-0.45; VigiBase: ROR 1.38, 95% CI 1.27-1.49; IC 0.46, 95% CI 0.34-0.57), while liraglutide and tirzepatide showed no SDRs. Stratified analyses revealed increased disproportionality in females and healthcare professional reports. WSP analysis showed semaglutide-associated depression followed an early failure pattern, with no significant drug interactions identified with psychotropic medications. Interpretation: This pharmacovigilance investigation identified a semaglutide-specific SDR for depressive disorders across both databases, while liraglutide and tirzepatide showed no SDRs. Although inconsistent with reported protective effects in existing studies of GLP-1RAs, these findings suggest drug-specific rather than class-wide safety monitoring is warranted. Funding: This work was supported by grants from the Foshan "Fourteen Five" Key Medical Specialty Construction Project (grant number FSZD145035) and Natural Science Foundation of Hunan Province (grant number 2023JJ60520).
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