Drug Safety

Article	Citations
Comment on “Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments”	239
Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”	158
Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review	123
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance	112
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review	72
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants	67
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System	54
Physician Awareness of FDA’s Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic	54
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative	53
Acknowledgement to Referees	51
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure	50
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard	48
Meeting Report: Herbal and Dietary Supplement Safety Surveillance Summit	46
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis	45
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database	44
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy	42
NSAIDs Use During Herpes Zoster Infection and Stroke Risk: A Nationwide Case-Crossover Study	40
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes	40
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review	39
Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase	37
US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)	34
A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)	33
Comment on "Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"	33
Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands	32
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study	31

Critical Appraisal of Artificial Intelligence for Rare-Event Recognition: Principles and Pharmacovigilance Case Studies	30
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury	30
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22	30
Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center	29
Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up	29
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	29
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products	28
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update	28
Sex Differences in Electrolyte Disturbances Among Diuretic Users According to Renal Function and Age	28
BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials	27
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products	27
Acknowledgement to Referees	27
Correction: Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making—Report from the 4th ISoP Africa Chapter Meeting	27
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis	25
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks	25
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance	25
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis	24
Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore	24
The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications	23
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019	23
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health	23
Principles and Practice of Pharmacovigilance and Drug Safety	23
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	22
Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”	22
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India	22
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes	22
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed	22
Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group	21
Authors’ response to Tiffet et al.’s comment on “Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments”	21
Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: a Swedish Population-Based Cohort Study	20
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials	20
Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data	20
Predictive Models for Identifying Adult Patients at High Risk of Developing Opioid-Related Harms: a Systematic Review	20
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study	20
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database	19
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System	19
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database	19
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023	18
Assessment of Pharmacovigilance Across University Hospitals in Morocco	18
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes	18
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes	18
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience	18
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database	18
Sexual Dysfunction in Male Patients After Initiating Treatment with Antidepressants	17
International Medicinal Product Information Documents: A Quantitative Content Analysis of Instructions for Preventing, Mitigating, and Monitoring Adverse Drug Reactions	17
Large-scale Empirical Identification of Candidate Comparators for Pharmacoepidemiological Studies	16
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies	16
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project	16
Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions	16
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes	16

Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study	16
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review	16
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis	16
Future of ChatGPT in Pharmacovigilance	15
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study	15
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry	15
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)	15
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exp	15
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre	15
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups	15
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”	14
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions	14
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore	14
Machine Learning in Causal Inference: Application in Pharmacovigilance	14
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance	14
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection	13
Signaling COVID-19 Vaccine Adverse Events	13
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study	13
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally	13
Real-World Data Insights into Antidepressant Prescription and Adherence During Pregnancy in Catalonia (Spain)	13
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies	13
Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database	13
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data	13
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities	13
Fatal Intoxications with Zopiclone—A Cause for Concern?	13
Correction: Assessing the Use of Medical Insurance Claims and Electronic Health Records to Measure COVID‑19 Vaccination During Pregnancy	13
Comment on “Drug-Induced Cognitive Impairment”	12
Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis	12
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea	12
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy	12
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls	12
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy	12
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries	12
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ	11
Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment	11
Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries	11
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry	11
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions	11
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal I	11
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes	11
Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis	10
Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis	10
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project	10
Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	10
Authors’ Response to Weng et al.’s Comment on “Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study”	10
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients	10
Correction: Charting and Sidestepping the Pitfalls of Disproportionality Analysis	10
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults	10
Association of Strict Versus Lenient Cholesterol Lowering with Cardiac Outcomes, Diabetes Progression and Complications, and Mortality in Patients with Diabetes Treated with Statins: Is Less More?	10
Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance	10
OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation	10
A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs	9
Signals of Adverse Reactions to Herbal Medicines: Evidence and Document Analysis Based on a Scoping Review	9
The Impact of COVID-19 and COVID-19 Vaccination on Detection, Assessment, and Management of Suspected Acute Drug‐Induced Liver Injury Occurring during Clinical Trials: Consensus Recommendations from t	9
Appeal for Increasing the Impact of Pharmacovigilance	9
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study	9
A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines	9
9th ISoP Intelligent Automation Boston Seminar: From Innovation to Impact. Building Trustworthy AI in Pharmacovigilance 4–5 December 2025 | Cambridge, USA & Virtual	9
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies	9
Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance	9
Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm	9
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments	9
The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities	9
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance	9
Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France	9
Author’s Reply to Kuss and Rathmann’s Comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events	9
Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study	8
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study	8
Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System	8
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review	8
Authors' response to Tran et al.'s comment on “The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore P	8
REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice	8
Intelligent Telehealth in Pharmacovigilance: A Future Perspective	8
Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis	8
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021	8
IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials	8
Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study	8
What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study	8
Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health/Medical Records: A Scoping Review	8
Risk of Cancer Comparing Warfarin and Direct Oral Anticoagulants: Population-Based Cohort Studies in England and Hong Kong	8

The Effect of Opioid Agonist Treatment on Injection-Related Sequelae: A Population-Based Observational Study	8
Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe	8
Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting	8
Managing Drug Interactions with Enzalutamide in Patients with Prostate Cancer: A Podcast	8
Conundrum of Clinical QTc Monitoring	7
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics	7
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study	7
Evaluating COVID-19 Vaccine Masking and Unmasking Methods in Two National Pharmacovigilance Databases	7
Systematic Evaluation of Australian Risk Management Plans for Biologic Medicines	7
Investigation of Ochratoxin A and Citrinin Occurrence in Medicinal Herbal Products from the Czech Market	7
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems	7
Choosing an Index Date for Untreated Patients in External Comparator Studies	7
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study	7
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations	7
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase	7
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration	7
Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity	6
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season	6
Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study	6
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS	6
Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial	6
Temporal Changes in Reporting of Neurodevelopmental Outcomes After Maternal Exposure to Valproate: A Contribution of the ConcePTION Project	6
Correction: Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	6
Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®	6
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease	6
Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials	6
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update	6
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation	6
Comment on: "Should Antidepressants be Avoided in Pregnancy?"	6
Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data	6
Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data	6
Disseminated Intravascular Coagulation Following Idarucizumab and Andexanet Alfa: Assessment of a Signal of Disproportionate Reporting From the Food and Drugs Administration Adverse Event Reporting Sy	6
The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients	6
Should Antidepressants be Avoided in Pregnancy?	5
An Evaluation of Duplicate Adverse Event Reports Characteristics in the Food and Drug Administration Adverse Event Reporting System	5
Characteristics of Drug-RElated Hospitalizations for Nursing HOme Residents: Cross-Sectional RENHO Study	5
Guillain–Barré Syndrome Following Recombinant Zoster Vaccine in US Medicare Adults Age 65 Years or Older	5
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement	5
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis	5
Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose	5
Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis	5
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies	5
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020	5
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	5
Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase®	5
Risk of Fetal Exposure to Teratogenic Medications: Development of Evidence for the Teratogenic Risk Impact and Mitigation (TRIM) Tool	5
The Value of Sensitivity Analyses in Assessing the Risk of Two Rare Neurological Adverse Events and Pseudoephedrine Use	5
Unveiling the Limits of Anticholinergic Burden Scales: A Study of Adverse Drug Reactions in the French Pharmacovigilance Database	5
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)	5
Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission	5
A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013–2021	4
Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method	4
Correction: Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	4
Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments	4
Clinical Relatedness and Stability of vigiVec Semantic Vector Representations of Adverse Events and Drugs in Pharmacovigilance	4
Comment on: Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study	4
Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands	4
The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic	4
Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region	4
Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories	4
Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink	4
Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions	4
A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis	4
Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea	4
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study	4
The Promise and Challenge of Large Language Models for Pharmacovigilance	4
Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis	4
Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes	4
How Important is Gender in Leadership in Pharmacovigilance? Personal Reflections from the First Female President of the International Society of Pharmacovigilance	4
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions	4
Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward	4
Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review	4
Characteristics and Risk Factors of Medication Incidents Across Stages of Medication Management in Residential Aged Care: A Longitudinal Cohort Study of 5700 Reported Incidents	4
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database	4
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases	4
Author’s Reply to Avó-Baião et al.’s Comment on “Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: A Swedish Population-	4
Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”	3
Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines	3
Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies	3
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making	3
Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	3
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?	3
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers	3
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports	3
Pharmacovigilance Through Fresh Eyes: The International Society of Pharmacovigilance Student Community's Role in Shaping the Future of Pharmacovigilance	3
Anticholinergic Drug Use in Elderly Patients: Compliance with STOPP-START and BEERS Criteria in Spain—A Descriptive Study	3
Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies	3
Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark	3
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data	3
Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study	3
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations	3
Prescription Drugs Subject to a Risk Evaluation and Mitigation Strategy: Patient Perspectives on Risk Communication and the Value of Educational Materials	3
Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media	3
Strategies and Challenges in Coding Ambiguous Information Using MedDRA®: An Exploration Among Norwegian Pharmacovigilance Officers	3
Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)	3