Results 11 to 20 of about 9,302 (232)

Real-world FAERS safety analysis of Pralsetinib

Scientific Reports
The FDA has approved pralsetinib as a chemotherapeutic drug for the treatment of individuals with cancers such as medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), and non-small cell lung cancer (NSCLC). However, there is a lack of information on drug safety in large cohorts.
Zhang, Dongdong, Sun, Yixin, Cai, Ying, Zeng, Peiji, Wang, Yue, Cai, Ming, Cai, Chengfu   +6 more
openaire   +4 more sources

A real-world pharmacovigilance analysis of omadacycline in FDA adverse event reporting system (FAERS) database [PDF]

Frontiers in Pharmacology
ObjectiveOmadacycline is a newly launched drug of tetracycline. Therefore, it is necessary to comprehensive evaluate reports on the safety of omadacycline in large, real-world populations.
Xueping Shi, Chen Wang, Xiang Liu, Li Zou, Pei Guo   +4 more
doaj   +2 more sources

Antibiotic-associated adverse events in bone and joint infections: a FAERS pharmacovigilance study

Frontiers in Medicine
BackgroundBone and joint infections (BJI) require prolonged antibiotic therapy that may amplify cumulative toxicity risk, yet indication-contextualized safety data remain sparse.MethodsUsing the FDA Adverse Event Reporting System (FAERS, 2004Q1-2025Q4 ...
Haoping Dai, Hongtao Li, Changming Xiao
doaj   +2 more sources

Adverse Event Profiles of Monoclonal Antibodies: A Descriptive Analysis of FAERS Data

Health Services Insights
Introduction Monoclonal antibodies (mAbs) are bioengineered molecules designed to replicate the immune system’s precise targeting of pathogens and abnormal cells.
Ghada Alem, Nehad Jaser Ahmed, Maram Ahmed, Mohamed Balaha, Ziyad Almalki, Abdullah Alahmari, Abdulla Alalwan   +6 more
doaj   +2 more sources

Characterization of skin adverse events associated with cetuximab: real-world insights from the two global pharmacovigilance databases of FAERS and VigiAccess

Frontiers in Oncology
BackgroundCetuximab, an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is widely used in metastatic colorectal cancer and other solid tumors. Cutaneous adverse events (AEs) are among its most frequent toxicities, but real-
Chenwen Li, Yifei Gao, Min Guang, Huajuan Wu, Yunfei Li, Yaqing Lu, Yan Wei, Xueli Li, Li Yang   +8 more
doaj   +2 more sources

A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases [PDF]

Frontiers in Pharmacology
BackgroundLecanemab and Aducanumab are two novel anti-amyloid beta (Aβ) therapies for Alzheimer’s disease (AD) that have shown promise in slowing cognitive decline. However, their safety profiles remain unclear due to limited real-world evidence.
Haoxiang Hu, Yunhan Zhao, Jiesheng Mao, Jianghai He, Yihan Zhang, Hongyu Ye, Xiaokai Yang   +6 more
doaj   +2 more sources

Safety assessment of sapropterin dihydrochloride: real-world adverse event analysis based on the FDA adverse event reporting system (FAERS) [PDF]

Frontiers in Pharmacology
ObjectiveSapropterin dihydrochloride is the first drug for the therapy of phenylketonuria, which is a rare disease that occurs one of 10,000–15,000 newborns.
Jiahong Zhong, Xihui Yu, Zhuomiao Lin
doaj   +2 more sources

Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS). [PDF]

, 2022
OBJECTIVE Neutropenia is a rare complication of anti-CD20 treatment, such as Ocrelizumab (OCR) in Multiple Sclerosis (MS). Using FDA´s Adverse Event Reporting System (FAERS), a post-marketing, open access pharmacovigilance database, we aimed to ...
Friedli, C, Salmen, A, Pistor, M, Hammer, H, Kamber, N, Chan, A, Hoepner, R, Diem, L, N Kamber, R Hoepner, A Salmen, L Diem, M Pistor, A Chan, H Hammer, C Friedli   +15 more
core   +1 more source

Comparison of the lnROR between FAERS and JADER.

, 2021
The lnROR of FAERS and JADER by each drug. Each line is a drug.
Junko Nagai (11785635), Yoichi Ishikawa (480629)   +1 more
core   +1 more source

Non‐Relapse Mortality With Bispecific Antibodies in Hematologic Malignancies: A Dual Systematic Review and Pharmacovigilance Analysis [PDF]

Hematol Oncol
ABSTRACT Bispecific antibodies (BsAbs) redirect T‐cells to tumor antigens in an MHC‐independent manner. These universally available, off‐the‐shelf products have demonstrated unprecedented efficacy in heavily pretreated patients with relapsed/refractory (R/R) hematological malignancies (HMs).
Irfan S, Khosla H, Nasir S, Kaur M, Varisco T, Ononogbu O, Singh S, Abid M.   +7 more
europepmc   +2 more sources