Drug Safety

Papers
(The TQCC of Drug Safety is 9. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2022-08-01 to 2026-08-01.)
ArticleCitations
Comment on “Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments”293
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System200
Physician Awareness of FDA’s Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic139
Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review74
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance58
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review56
Sexual Dysfunction Among Males Living with HIV Receiving Dolutegravir-Based Antiretroviral Therapy in Uganda: A Cross-sectional Study53
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants52
Enhancing Disease Surveillance and Pharmacovigilance Practices for RTS,S/AS01E Malaria Vaccine Rollout in Ghana, Kenya, and Malawi: Strategies, Impact, Challenges, and Lessons Learned48
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative47
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure45
Acknowledgement to Referees45
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard44
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database39
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy38
Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase36
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes35
NSAIDs Use During Herpes Zoster Infection and Stroke Risk: A Nationwide Case-Crossover Study35
Assessing the Risk of Adverse Maternal and Infant Outcomes Following Prenatal Modafinil Exposure: A French Nationwide Cohort Study35
Meeting Report: Herbal and Dietary Supplement Safety Surveillance Summit33
US Risk Evaluation and Mitigation Strategies with Elements to Assure Safe Use: A Longitudinal Analysis of REMS Modifications (2008–2022)33
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis33
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review32
Critical Appraisal of Artificial Intelligence for Rare-Event Recognition: Principles and Pharmacovigilance Case Studies31
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"30
Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands29
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study28
Sex Differences in Electrolyte Disturbances Among Diuretic Users According to Renal Function and Age27
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database27
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury27
Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center27
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–2226
Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up26
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products25
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products24
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks23
Acknowledgement to Referees23
Correction: Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making—Report from the 4th ISoP Africa Chapter Meeting23
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis22
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update21
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health21
Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore21
The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications21
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance20
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis20
The Bidirectionality of Lawyer Reporting Bias in Disproportionality Analysis20
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review19
Principles and Practice of Pharmacovigilance and Drug Safety19
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study18
Predictive Models for Identifying Adult Patients at High Risk of Developing Opioid-Related Harms: a Systematic Review18
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials18
Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”18
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed18
Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data18
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System17
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”17
Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: a Swedish Population-Based Cohort Study17
Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group17
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes17
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India17
Assessment of Pharmacovigilance Across University Hospitals in Morocco16
Large-scale Empirical Identification of Candidate Comparators for Pharmacoepidemiological Studies16
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes16
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study16
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 202316
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database16
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis15
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database15
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project15
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review15
International Medicinal Product Information Documents: A Quantitative Content Analysis of Instructions for Preventing, Mitigating, and Monitoring Adverse Drug Reactions15
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience15
Sexual Dysfunction in Male Patients After Initiating Treatment with Antidepressants15
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes15
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies14
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 Study14
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes14
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)14
Correction: The Bidirectionality of Lawyer Reporting Bias in Disproportionality Analysis14
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups14
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”13
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-exp13
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore13
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry13
Future of ChatGPT in Pharmacovigilance13
Real-World Data Insights into Antidepressant Prescription and Adherence During Pregnancy in Catalonia (Spain)13
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre13
Fatal Intoxications with Zopiclone—A Cause for Concern?12
Correction: Assessing the Use of Medical Insurance Claims and Electronic Health Records to Measure COVID‑19 Vaccination During Pregnancy12
Comment on “Drug-Induced Cognitive Impairment”12
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions12
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies12
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection12
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance12
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities12
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study12
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally12
Safety and Management of Targeted Therapies for Relapsed/Refractory Chronic Lymphocytic Leukemia12
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data12
Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis11
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy11
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls11
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes11
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea11
Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience10
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 I10
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 Project10
OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation10
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries10
Correction: Charting and Sidestepping the Pitfalls of Disproportionality Analysis10
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy10
Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis10
Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment10
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ10
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
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry10
A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs9
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults9
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance9
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies9
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study9
Authors’ Response to Weng et al.’s Comment on “Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study”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 Events9
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 t9
9th ISoP Intelligent Automation Boston Seminar: From Innovation to Impact. Building Trustworthy AI in Pharmacovigilance 4–5 December 2025 | Cambridge, USA & Virtual9
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients9
Appeal for Increasing the Impact of Pharmacovigilance9
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments9
Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm9
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