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 2021-06-01 to 2025-06-01.)
ArticleCitations
Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception96
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance90
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”86
Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity68
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants66
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System62
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative61
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports58
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review56
Acknowledgement to Referees53
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR52
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy50
Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study48
High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases42
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review41
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure41
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard37
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database35
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database32
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis32
Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis30
Comment on: "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholde29
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury29
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study28
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"28
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products26
A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)26
Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks26
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–2226
Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data25
Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines24
The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications22
BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials21
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health21
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis21
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis21
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance21
A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)20
Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore20
β-Blockers and the Risk of Depression: A Matched Case–Control Study20
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update20
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study19
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes19
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products19
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed19
Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season19
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 201919
Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the 19
Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”19
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review18
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database17
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials17
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
Principles and Practice of Pharmacovigilance and Drug Safety17
Predictive Models for Identifying Adult Patients at High Risk of Developing Opioid-Related Harms: a Systematic Review16
Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: a Swedish Population-Based Cohort Study16
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System16
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 202315
Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions15
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database15
Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data15
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes15
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review15
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database15
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study15
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes15
Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Even14
Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports14
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience14
The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 202114
Assessment of Pharmacovigilance Across University Hospitals in Morocco14
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project13
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre13
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis13
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies13
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups13
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes13
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)13
Future of ChatGPT in Pharmacovigilance12
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance12
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies12
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-exp12
NSAIDs and COVID-19: A Systematic Review and Meta-analysis12
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally12
Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models12
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 Study12
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”12
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry12
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities11
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection11
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study11
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy11
Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles11
Fatal Intoxications with Zopiclone—A Cause for Concern?11
Signaling COVID-19 Vaccine Adverse Events11
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore11
Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database11
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy11
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data11
Machine Learning in Causal Inference: Application in Pharmacovigilance11
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions11
Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity11
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls11
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea11
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry10
Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study10
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
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions10
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults10
Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis10
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes10
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
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
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ10
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries10
OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation9
COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Mar9
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
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 Project9
Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding9
Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study9
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients9
Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance9
Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders9
Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries9
Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review9
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
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