Drug Safety
2012 - 2025
Current editor(s): Nitin Joshi From Springer Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing (). Access Statistics for this journal.
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Volume 48, issue 6, 2025
- Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety pp. 587-593

- Tarek A. Hammad and Simon Davies
- Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials pp. 595-606

- Richard C. Zink, Rebecca Lyzinski and Geoffrey Mann
- Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review pp. 607-641

- Andrea M. Russell, Rebecca Lovett, Abigail Vogeley, Denise A. Nunes, Carolyn McKelvie, Wayne Middleton and Michael Wolf
- Delphi Method Consensus on Statistical Analysis and Reporting Recommendations for Single-Arm Pregnancy Medication Safety Studies Investigating Pregnancy, Birth and Neonatal Health Outcomes: A Contribution from IMI-ConcePTION pp. 643-654

- Jonathan L. Richardson, Alan Moore, Michael Stellfeld, Yvonne Geissbühler, Ursula Winterfeld, Guillaume Favre, Christina Chambers, Evelin Beck, Marlies Onken, Katarina Dathe, Michael Ceulemans, Orna Diav-Citrin, Svetlana Shechtman, Alison M. Oliver, Kenneth K. Hodson, Dee-Dee Shiller, Amalia Alexe, Eugène P. Puijenbroek, David J. Lewis and Laura M. Yates
- Leveraging FDA Labeling Documents and Large Language Model to Enhance Annotation, Profiling, and Classification of Drug Adverse Events with AskFDALabel pp. 655-665

- Leihong Wu, Hong Fang, Yanyan Qu, Joshua Xu and Weida Tong
- Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore pp. 667-677

- Yen Ling Koon, Yan Tung Lam, Hui Xing Tan, Desmond Hwee Chun Teo, Jing Wei Neo, Aaron Jun Yi Yap, Pei San Ang, Celine Ping Wei Loke, Mun Yee Tham, Siew Har Tan, Sally Leng Bee Soh, Belinda Qin Pei Foo, Zheng Jye Ling, James Luen Wei Yip and Sreemanee Raaj Dorajoo
- Are Causal Statements Reported in Pharmacovigilance Disproportionality Analyses Using Individual Case Safety Reports Exaggerated in Related Citations? A Meta-epidemiological Study pp. 679-688

- Claire Bernardeau, Bruno Revol, Francesco Salvo, Michele Fusaroli, Emanuel Raschi, Jean-Luc Cracowski, Matthieu Roustit and Charles Khouri
- Pharmacogenetic Testing in the Outpatient Setting in Switzerland: A Descriptive Study Using Swiss Claims Data pp. 689-696

- Nina L. Wittwer, Christoph R. Meier, Carola A. Huber, Henriette E. Meyer zu Schwabedissen, Samuel Allemann and Cornelia Schneider
- Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update pp. 697-713

- Sigal Kaplan, Andra Ghimpeteanu and Claudia Florentina Dragut
Volume 48, issue 5, 2025
- Emerging Tools to Support DILI Assessment in Clinical Trials with Abnormal Baseline Serum Liver Tests or Pre-existing Liver Diseases pp. 443-453

- Jasmine Amirzadegan, Bereket Tesfaldet, Y. Veronica Pei, Eileen Navarro Almario, Mark I. Avigan and Paul H. Hayashi
- Drug Induced Liver Injury: Highlights and Controversies in the 2023 Literature pp. 455-488

- Harjit Singh, Bryce F. Kunkle, Angela R. Troia, Advait M. Suvarnakar, Ade C. Waterman, Yadana Khin, Serena Y. Korkmaz, Corinne E. O’Connor and James H. Lewis
- Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example pp. 489-502

- Saad Hanif Abbasi, Lars Christian Lund, Jesper Hallas and Anton Pottegård
- Risk of Fracture Associated with Pregabalin or Mirogabalin Use: A Case-Case-Time-Control Study Based on Japanese Health Insurance Claims Data pp. 503-511

- Hinako Wakabayashi, Toshiki Fukasawa, Satomi Yoshida, Kairi Ri, Soichiro Masuda, Takayuki Anno and Koji Kawakami
- Network Analysis and Machine Learning for Signal Detection and Prioritization Using Electronic Healthcare Records and Administrative Databases: A Proof of Concept in Drug-Induced Acute Myocardial Infarction pp. 513-526

- Maria Antonietta Barbieri, Andrea Abate, Olivér M. Balogh, Mátyás Pétervári, Péter Ferdinandy, Bence Ágg, Vera Battini, Marianna Cocco, Andrea Rossi, Carla Carnovale, Manuela Casula, Edoardo Spina and Maurizio Sessa
- Assessment of Pharmacovigilance Across University Hospitals in Morocco pp. 527-539

- Hind Hamzaoui, Anna Shaum, Imad Cherkaoui, Latifa Ait Moussa, Houda Sefiani, Ismail Talibi, Ghita Benabdallah, Omar Salman, Seth Ferrey and Rachida Soulaymani Bencheikh
- A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013–2021 pp. 541-558

- Annette Kjær Ersbøll, Zhiping Huang, Deanna D. Hill, Simone Møller Hede, Vibeke Andersen, Kristian Bolin, Marie Skov Kristensen, Suzan Esslinger, Frida Richter Hansen, Erik Hertervig, Lila Kallio, Thora Majlund Kjærulff, Stine Kloster, Alexis Krumme, James D. Lewis, Laila Mehkri, Niels Qvist, Lau Caspar Thygesen, Cindy Weinstein and Anders Green
- Opinion Mining of Erowid’s Experience Reports on LSD and Psilocybin-Containing Mushrooms pp. 559-575

- Ahmed Al-Imam, Riccardo Lora, Marek A. Motyka, Erica Marletta, Michele Vezzaro, Jerzy Moczko, Manal Younus and Michal Michalak
- Multi-Stakeholder Call to Action for the Future of Vaccine Post-Marketing Monitoring: Proceedings from the First Beyond COVID-19 Monitoring Excellence (BeCOME) Conference pp. 577-585

- Vincent Bauchau, Kaatje Bollaerts, Phil Bryan, Jim Buttery, Kourtney Davis, Robert T. Chen, Daniel R. Feikin, Antonella Fretta, Sarah Frise, Sonja Gandhi-Banga, Hector S. Izurieta, Corinne Jouquelet-Royer, Alena Khromava, Lin Li, Raj Long, Sarah MacDonald, Lydie Marcelon, Robert Massouh, Wilhelmine Meeraus, Flor M. Munoz, Karen Naim, Dale Nordenberg, Hanna Nohynek, Heather Rubino, Daniel A. Salmon, Sarah Sellers, Laurence Serradell, Laurence Torcel-Pagnon and Jamie Wilkins
Volume 48, issue 4, 2025
- Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health pp. 315-320

- Carlotta Lunghi, Maria Rosa Valetto, Anna Barra Caracciolo, Irene Bramke, Sergio Caroli, Paola Bottoni, Sara Castiglioni, Salvatore Crisafulli, Laura Cuzzolin, Paola Deambrosis, Valentina Giunchi, Jacopo Grisotto, Antonio Marcomini, Ugo Moretti, Vitalia Murgia, Jayesh Pandit, Stefano Polesello, Elisabetta Poluzzi, Roberto Romizi, Nicoletta Scarpa, Giovanna Scroccaro, Raffaella Sorrentino, Anders Sundström, John Wilkinson and Giovanna Paolone
- Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health/Medical Records: A Scoping Review pp. 321-337

- Su Golder, Dongfang Xu, Karen O’Connor, Yunwen Wang, Mahak Batra and Graciela Gonzalez Hernandez
- Drug-Induced Cognitive Impairment pp. 339-361

- Arne Reimers, Per Odin and Hanna Ljung
- Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study pp. 363-374

- Joseph M. Plasek, Mary G. Amato, Abigail Salem, Dinah Foer, Stuart Lipsitz, Gretchen Purcell Jackson, David W. Bates and Li Zhou
- Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study pp. 375-388

- Unnur Gudnadottir, Emma Fransson, Gustaf Ljungman, Anna Wikman, Erika Vlieghe, Lars Engstrand and Nele Brusselaers
- Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study pp. 389-400

- Nele Brusselaers, Unnur Gudnadottir, Lars Engstrand and Helene E. Lilja
- Clinical Relatedness and Stability of vigiVec Semantic Vector Representations of Adverse Events and Drugs in Pharmacovigilance pp. 401-413

- Nils Erlanson, Joana Félix China, Henric Taavola and G. Niklas Norén
- Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey pp. 415-423

- Samantha E. Duckworth, Sophie Druelles, Emily Brouwer, David A. Brown, Katja M. Hakkarainen and Sonia Guleria
- OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation pp. 425-436

- Achilleas Chytas, George Gavriilides, Anargyros Kapetanakis, Alix Langlais, Marie-Christine Jaulent and Pantelis Natsiavas
- Comment on: “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” pp. 437-438

- Minh-Hoang Tran and Kim-Huong Truong-Nguyen
- 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 Potential Risks and Complications” pp. 439-441

- Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J. Moran, Kirsten R. Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede and Joanne Enticott
Volume 48, issue 3, 2025
- Pharmacovigilance in the Community: A Special-Interest Group of the International Society of Pharmacovigilance pp. 203-207

- Mohamed A. Elhawary, Rebecca Noss, Loubna Alj, Manal Younus, Mayada Alkhakany, Hadir Rostom, Angela Caro-Rojas and Thamir M. Alshammari
- Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa pp. 209-216

- Robin Schaefer, L. Donaldson, A. Chigome, M. Escudeiro dos Santos, S. Lamprianou, N. Ndembi, J. I. Nwokike, P. Nyambayo, V. Palmi, F. Renaud, M. Gonzalez Tome and V. Miller
- Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database pp. 217-231

- Sara Ferraro, Emiliano Cappello, Marco Fornili, Irma Convertino, Marco Bonaso, Ersilia Lucenteforte and Marco Tuccori
- Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID-19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group pp. 233-249

- Victoria Prudence Nambasa, Hannah May Gunter, Modupe Bamidele Adeyemo, Neetesh Yanish Bhawaneedin, Marc Blockman, George Tsey Sabblah, John Owusu Gyapong, Eric Muriithi Guantai, Tamrat Abebe, Workeabeba Abebe, Henry Jeremy Lawson, Mercedes Chawada Leburu, Abdullahi Mohammed, Kwame Amponsa-Achiano, Mafora Florah Matlala, Uchenna Geraldine Elemuwa, Hudu Mogtari, Alexander Kwadwo Nyarko, Marione Schönfeldt, Mercy Kamupira, Kerrigan McCarthy, Yohannes Lakew Tefera, Asnakech Alemu, Kabir Mawashi Yusuf, Obi Emelife, Ladji Sidibe, Kudakwashe Dandajena, Kenneth Onu, Mojisola Christianah Adeyeye, Delese Mimi Darko, Heran Gerba, Boitumelo Semete, Fred Siyoi, Aggrey Ambali and Johanna Catharina Meyer
- Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database pp. 251-263

- Dalil Boulefaa, Haleh Bagheri, Francesco Salvo, Marie-Blanche Rabier, Hélène Geniaux, Marion Lepelley, Fanny Rocher, Julien Mahe, Aurélie Grandvillemuin and Hung Thai- Van
- Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study pp. 265-277

- Mylène Tisseyre, Mathis Collier, Nathanaël Beeker, Florentia Kaguelidou, Jean-Marc Treluyer and Laurent Chouchana
- Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS) pp. 279-286

- Mayra Oliveira, Paige Marquez, Carol Ennulat, Phillip Blanc, Kerry Welsh, Narayan Nair, Monica Taminato and Pedro L. Moro
- Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments pp. 287-303

- Jürgen Dietrich and André Hollstein
- Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance pp. 305-309

- Omar Aimer, Maribel Salas, Tarek A Hammad, Rania Mouchantaf, Katarina Ilic, Maxine Gossell-Williams, Ushma Mehta, Robert W. Platt and Bruce Carleton
- Principles and Practice of Pharmacovigilance and Drug Safety pp. 311-314

- Ian W. Boyd
Volume 48, issue 2, 2025
- Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation pp. 107-117

- Almut G. Winterstein, Celeste L. Y. Ewig, Yanning Wang, Nicole E. Smolinski, Gita A. Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Esther H. Zhou, Vakaramoko Diaby, Amir Sarayani, Thuy Thai, Judith C. Maro and Sonja A. Rasmussen
- Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance pp. 119-127

- Ashish Jain, Maribel Salas, Omar Aimer and Zahabia Adenwala
- Drug-Induced Hypouricemia pp. 129-142

- Chaker Ben Salem, Myriam Agrebi, Dhouha Sahnoun, Neila Fathallah and Houssem Hmouda
- Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury pp. 143-150

- Dina Halegoua-DeMarzio, Victor J. Navarro, Ashley Davis, Jawad Ahmad, Bharathi Avula, Huiman Barnhart, A. Sidney Barritt, Herbert L. Bonkovsky, Vincent L. Chen, Gina Choi, Robert J. Fontana, Marwan S. Ghabril, Ikhlas Khan, Christopher Koh, Joseph Odin, Don C. Rockey, Hoss Rostami, Jose Serrano, Averell H. Sherker, Andrew Stolz, Hans L. Tillmann and Raj Vuppalanchi
- Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs pp. 151-160

- Vincent L. Chen, Don C. Rockey, Einar S. Bjornsson, Huiman Barnhart and Jay H. Hoofnagle
- Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study pp. 161-177

- Mathias Møllebæk, Helga Gardarsdottir, Alexia-Georgia Bikou, Ana Kodrič, Ana Marta Silva, Armin Andersen, Christos Kontogiorgis, Elita Poplavska, Fariba Ahmadizar, Foteini Dermiki-Gkana, Ieva Rutkovska, Inês Ribeiro Vaz, Mitja Kos, Paula Barão, Renske Grupstra, Teresa Leonardo Alves and Anna Birna Almarsdóttir
- Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study pp. 179-190

- Eyob Alemayehu Gebreyohannes, Christopher Thornton, Myra Thiessen, Sieta T. Vries, Gretchen Coombs, Indae Hwang and Renly Lim
- Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase pp. 191-201

- Adrian Martinez de la Torre, Andreas Bech Clausen, Andrea M. Burden and Stefan Weiler
Volume 48, issue 1, 2025
- Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices pp. 1-5

- Yoshihiro Noguchi, Tomoya Tachi and Tomoaki Yoshimura
- Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials pp. 7-23

- Shih-Hao Cheng, William Chu, Wen-Hsiang Chou, Woei-Chyn Chu and Yi-No Kang
- Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis pp. 25-42

- Pajaree Mongkhon, Noppaket Singkham, Kunyarat Ponok, Natpatsorn Liamsrijan, Wipada Phoosa, Sirayut Phattanasobhon, Laura Fanning, Vichai Senthong and Surasak Saokaew
- An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury pp. 43-58

- Daniel Fernández-Llaneza, Romy M. P. Vos, Joris E. Lieverse, Helen R. Gosselt, Sandra L. Kane-Gill, Teun Gelder and Joanna E. Klopotowska
- Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups pp. 59-74

- Victor Pera, Jan A. Kors, Erik M. Mulligen, Marcel Wilde, Peter R. Rijnbeek and Katia M. C. Verhamme
- Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide pp. 75-86

- Corine Ekhart, Sjoerd H. P. Wiarda, Sonja Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag and Florence Hunsel
- 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 pp. 87-97

- Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J. Moran, Kirsten R. Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede and Joanne Enticott
- Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products pp. 99-105

- Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze and John W. Ayers
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