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 2022-05-01 to 2026-05-01.)
ArticleCitations
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 Review123
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance112
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review72
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants67
Physician Awareness of FDA’s Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic54
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System54
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative53
Acknowledgement to Referees51
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure50
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard48
Meeting Report: Herbal and Dietary Supplement Safety Surveillance Summit46
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis45
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database44
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy42
NSAIDs Use During Herpes Zoster Infection and Stroke Risk: A Nationwide Case-Crossover Study40
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes40
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review39
Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase37
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 Netherlands32
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study31
Critical Appraisal of Artificial Intelligence for Rare-Event Recognition: Principles and Pharmacovigilance Case Studies30
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury30
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–2230
Health Information Exchanges (HIEs) as Novel Sources for Population-Based Post Marketing Surveillance of Medical Products: A Pilot Study from the FDA Sentinel Innovation Center29
Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up29
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database29
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products28
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update28
Sex Differences in Electrolyte Disturbances Among Diuretic Users According to Renal Function and Age28
Correction: Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making—Report from the 4th ISoP Africa Chapter Meeting27
BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials27
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products27
Acknowledgement to Referees27
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance25
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis25
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks25
Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore24
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis24
Principles and Practice of Pharmacovigilance and Drug Safety23
The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications23
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 201923
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health23
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review22
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 India22
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes22
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed22
Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group21
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 Study20
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials20
Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data20
Predictive Models for Identifying Adult Patients at High Risk of Developing Opioid-Related Harms: a Systematic Review20
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study20
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database19
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System19
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database19
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database18
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 202318
Assessment of Pharmacovigilance Across University Hospitals in Morocco18
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes18
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes18
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience18
Sexual Dysfunction in Male Patients After Initiating Treatment with Antidepressants17
International Medicinal Product Information Documents: A Quantitative Content Analysis of Instructions for Preventing, Mitigating, and Monitoring Adverse Drug Reactions17
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study16
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review16
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis16
Large-scale Empirical Identification of Candidate Comparators for Pharmacoepidemiological Studies16
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies16
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project16
Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions16
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes16
Future of ChatGPT in Pharmacovigilance15
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 Study15
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry15
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-exp15
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre15
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups15
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions14
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”14
Machine Learning in Causal Inference: Application in Pharmacovigilance14
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore14
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance14
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection13
Signaling COVID-19 Vaccine Adverse Events13
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study13
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally13
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 Studies13
Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database13
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data13
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities13
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 Pregnancy13
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls12
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy12
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries12
Comment on “Drug-Induced Cognitive Impairment”12
Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis12
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea12
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy12
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 I11
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes11
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ11
Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment11
Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries11
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry11
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions11
OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation10
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
Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis10
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
Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review10
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 Patients10
Correction: Charting and Sidestepping the Pitfalls of Disproportionality Analysis10
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults10
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 Pharmacovigilance10
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance9
Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France9
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
A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs9
Signals of Adverse Reactions to Herbal Medicines: Evidence and Document Analysis Based on a Scoping Review9
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
Appeal for Increasing the Impact of Pharmacovigilance9
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study9
A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines9
9th ISoP Intelligent Automation Boston Seminar: From Innovation to Impact. Building Trustworthy AI in Pharmacovigilance 4–5 December 2025 | Cambridge, USA & Virtual9
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies9
Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance9
Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm9
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments9
The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities9
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