Safety assessment of laronidase: real-world adverse event analysis based on the FDA adverse event reporting system (FAERS) [PDF]
ObjectiveLaronidase is the first drug of enzyme replacement therapy approved for the treatment of mucopolysaccharidosis type I (MPS I). However, its adverse events (AEs) have not been investigated in real - world settings.
Zhuomiao Lin +4 more
doaj +2 more sources
Indications and adverse events of teriparatide: based on FDA adverse event reporting system (FAERS)
BackgroundTeriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.ObjectiveTo investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for ...
Ming-Tao Wen +11 more
doaj +3 more sources
IntroductionHepatitis B virus (HBV) is a major cause of chronic liver disease. While the hepatitis B vaccine has been proven effective in preventing HBV infection, concerns regarding Events Supposedly Attributable to Vaccination or Immunization (ESAVI ...
Yiqing Sun +4 more
doaj +3 more sources
Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system. [PDF]
Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of
Akiho Fukuda +12 more
doaj +3 more sources
Exploration of adverse event profiles for cefotaxime: a disproportionality analysis using the FDA adverse event reporting system [PDF]
Background Cefotaxime has been widely used in the clinical treatment of infections. However, there is still a lack of systematic researches for the adverse event profiles of cefotaxime through large-scale post-marketing monitoring.
Cheng Jiang +3 more
doaj +2 more sources
Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database [PDF]
Data on adverse drug events (ADEs) observed at the population level provide important evidence regarding the safety of a pharmaceutical product in real-world settings. Recent patterns in serious and fatal ADE reporting have not been documented.To assess recent patterns in serious and fatal ADE reports in the United States.We conducted a retrospective ...
Kalyani Sonawane +2 more
openalex +4 more sources
Osimertinib-related myotoxicity: a disproportionality analysis of the FDA adverse event reporting system [PDF]
Background Osimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor that has been widely applied as a standard first-line treatment in advanced non-small cell lung cancer.
Yaqian Tan, Qi Song
doaj +2 more sources
BackgroundVortioxetine is a novel antidepressant belonging to the class of selective serotonin reuptake inhibitors. This study aims to comprehensively analyze the adverse events (AEs) associated with vortioxetine by analyzing the FDA Adverse Event ...
Liangxia Li +4 more
doaj +3 more sources
A disproportionality analysis of FDA adverse event reporting system events for misoprostol
Misoprostol was originally used to treat gastric ulcers, and has been widely used in abortion, cervical maturation, induced labour and postpartum hemorrhage. But there are still many undetected adverse events (AEs).
Li Yang, Wenting Xu
doaj +3 more sources
BackgroundAmlodipine, a widely prescribed clinical medication, is associated with adverse reactions that can impede the proper execution of treatment regimens.
Jiazhen Jiang +6 more
doaj +3 more sources

