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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 ().

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Volume 48, issue 6, 2025

Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety pp. 587-593 Downloads
Tarek A. Hammad and Simon Davies
Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials pp. 595-606 Downloads
Richard C. Zink, Rebecca Lyzinski and Geoffrey Mann
Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review pp. 607-641 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
Su Golder, Dongfang Xu, Karen O’Connor, Yunwen Wang, Mahak Batra and Graciela Gonzalez Hernandez
Drug-Induced Cognitive Impairment pp. 339-361 Downloads
Arne Reimers, Per Odin and Hanna Ljung
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study pp. 363-374 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
Jürgen Dietrich and André Hollstein
Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance pp. 305-309 Downloads
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 Downloads
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 Downloads
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 Downloads
Ashish Jain, Maribel Salas, Omar Aimer and Zahabia Adenwala
Drug-Induced Hypouricemia pp. 129-142 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
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 Downloads
Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze and John W. Ayers
Page updated 2025-06-08