Results 71 to 80 of about 9,302 (232)

Cardiovascular Toxicity Associated With Bispecific Antibodies in Hematological Malignancies: A Comprehensive Pharmacovigilance Analysis

American Journal of Hematology, Volume 101, Issue 10, Page 2546-2556, October 2026.
ABSTRACT Cardiovascular adverse events (CVAEs) associated with bispecific T‐cell engaging antibodies (BsAbs) have not been systematically investigated across approved agents. In this disproportionality analysis of FAERS (December 2014–September 2025), reports listing BsAbs as the primary suspected drug (n = 7647) were compared with all other drugs in ...
Malak Munir, Ahmed Sayed, Dae Hyun Lee, Sanam Ghazi, Mustafa M. Houmsse, Saad Badat, Abdul Moeed, Avirup Guha, Daniel Addison, Narendranath Epperla   +9 more
wiley   +1 more source

faers: A High-Fidelity Framework and R/Bioconductor Package for Precision Adverse Event Surveillance

The FDA Adverse Event Reporting System (FAERS) is a critical pillar of post-marketing pharmacovigilance, yet its utility is constrained by data heterogeneity, pervasive reporting redundancies, and inconsistent medical terminology, which impede ...
Yanru Cui, Yun Peng, Xiaoyun Bu, Chunyang Wang, Yankun Zhao, Jian-Guo Zhou, Bin Yan, Zimo Li, Chenyang Shu, Zhangyu Wang, Yujun Sun, Shixiang Wang   +11 more
core   +1 more source

Comparative safety profile of biktarvy: insights from a clinical cohort and the FAERS database

Frontiers in Pharmacology
BackgroundBiktarvy, a second-generation integrase strand-transfer inhibitor, is approved for treating human immunodeficiency virus (HIV) in patients with no known resistance to its components.
Xinmei Pan, Qingqing Tian, Qian Wang, Linli Xie, Jiangchuan Xie   +4 more
doaj   +1 more source

The Real‐World Safety Profile of Haloperidol: A Comprehensive Pharmacovigilance Analysis Using the Large‐Scale FAERS Database

CNS Neuroscience &Therapeutics, Volume 32, Issue 10, October 2026.
This first comprehensive FAERS‐based pharmacovigilance analysis of haloperidol over two decades characterized the real‐world safety profile across 9916 reports. Strong signals were found for nervous, psychiatric, and cardiac disorders. Known risks were confirmed and novel signals revealed. Sex‐ and age‐specific vulnerabilities were identified. Findings
Nengping Luo, Lu Xiao, Ying Liu, Xiang Liu   +3 more
wiley   +1 more source

Aioli:Standardising Drugs in the FDA Adverse Event Reporting System (FAERS) to RxNorm and Anatomical Therapeutic Chemical (ATC) Codes [PDF]

Purpose: The Food and Drug Administration Adverse Event Reporting System (FAERS) is an important source of information on suspected adverse drug reactions, but does not standardise drugs. The Adverse Event Open Learning Through Universal Standardization (
Kors, Jan A.; id_orcid, Verhamme, Katia M.C.; id_orcid, Pera, Victor; id_orcid, de Wilde, Marcel, Parry, Rowan E., van Mulligen, Erik M.; id_orcid   +5 more
core   +1 more source

Response to Xing et al.: post-marketing safety concerns with Lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database

Alzheimer’s Research & Therapy
A recent paper published a lecanemab analysis with data from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.
Michael Irizarry, Ilona Surick, Ari Michael, Lynn D. Kramer   +3 more
doaj   +1 more source

Severe Thrombocytopenia Associated With Glucagon‐Like‐1 Receptor Agonists (GPL‐1RA): A SONAR Report

Diabetes, Obesity and Metabolism, EarlyView.
Charles L. Bennett, Chadi Nabhan, Demir Uslu, Yogitha Dadi, David Aboulafia, Barbara Senger, Joseph Magagnoli, Kelvin Rojas, Gurdeep Singh, Linda Martin, Edward Smith, Samuel Ruder, Chien‐Hsiang Weng, Nikhil Uppal, Mia Lynch, James B. Bussel   +15 more
wiley   +1 more source

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Clinical Pharmacology &Therapeutics, Volume 120, Issue 4, Page 1120-1128, October 2026.
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow, Brendan Day, Esther H. Zhou, Corinne Woods, Nana Dwumfour, Jenni Y. Lee, Ilynn Bulatao, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, Nabila Sadiq, Farideh Sistani, Maggie Lee, Grace Chai, Gerald Dal Pan   +14 more
wiley   +1 more source

Analysis of adverse event reporting patterns following COVID-19 vaccination: findings from VigiAccess, FAERS and EudraVigilance databases with comparative assessment of data representation and categorization across three databases [PDF]

The clinical presentation of COVID-19 varied from mild to severe or fatal illness, and vaccination played a pivotal role in preventing the spread of severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). Despite cumulative evidence suggesting that
Bhave, Kiran A., Pandit, Prasad R., Mahurkar, Ram N., Patel, Tejal C.   +3 more
core   +1 more source

Expanding on Abraxane Safety: Temporal Insights and Future Directions for Adverse Event Analysis [Letter]

International Journal of Nanomedicine
Fangcai Yang,1 Wukun Ge2 1Department of Clinical Nutrition, Ninghai First Hospital, Ningbo, Zhejiang, 315600, People’s Republic of China; 2Department of Clinical Pharmacy, Ninghai First Hospital, Ningbo, Zhejiang, 315600, People’s Republic of
Yang F, Ge W
doaj