The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's...

The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and...

FDA rolled out the FDA Adverse Event Reporting System (FAERS), replacing the earlier AERS system. FAERS is an online database that is used by the FDA...

Administration (FDA) is responsible for monitoring post-marketing studies. The FDA has a reporting system called the FDA Adverse Event Reporting System, where...

AE reporting: One of the fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During...

disabling AE Grade 5 Death related to AE The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility...

Pharmacovigilance FDA Adverse Event Reporting System (FAERS) Sakai T (2021). "医療ビッグデータにおける自発報告データベースの位置づけと利用可能性" [Role and Applicability of Spontaneous Reporting Databases...

Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse...

as of 2013 only one case of adverse reaction to levosulpiride had been recorded on the FDA Adverse Event Reporting System Database. A case of rapid onset...

absolute risk is considered very low. In the FDA Adverse Event Reporting System an increase was reported in events of acute kidney injury associated with SGLT2...

and Drug Administration (FDA) analyzed cases of pruritus after stopping cetirizine in the FDA Adverse Event Reporting System (FAERS) database and medical...

sentinel events are recorded and published by the FDA's MedWatch program. Advantages of reporting sentinel events to The Joint Commission are: Adding to the...

pancreatitis.According to the FDA’s Adverse Events Reporting System (FAERS), more than 150 patients taking Ozempic reported ileus or intestinal obstructions...

Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data". Drugs in R&D. 17 (1):...

Inhibitors: A Pharmacovigilance Study with Data from the U.S. FDA Adverse Event Reporting System". Journal of Diabetes Research. 2020: 3695101. doi:10.1155/2020/3695101...

Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data". Drugs in R&D. 17 (1):...

Major adverse cardiovascular events (MACE, or major adverse cardiac events) is a composite endpoint frequently used in cardiovascular research. Despite...

case reports, hundreds of additional cases of liver complications in people taking bicalutamide exist in the FDA Adverse Event Reporting System (FAERS)...

sodium-channel blocking antiseizure medications. In March 2023, an FDA Adverse Event Reporting System analysis demonstrated signals of cardiac arrest, but not of...

Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the...

gravis exacerbation: evaluation of postmarketing reports from the US FDA adverse event reporting system and a literature review". Drug Safety. 34 (10):...

treatment-related. Spontaneous reports to the U.S. FDA Adverse Effects Reporting System at the time of the 20 September 2011 U.S. FDA Pediatric Drugs Advisory...

electronic health records and/or adverse event reports. Organizations such as the FDA Adverse Event Reporting System (FAERS) and the World Health Organization's...

Pharmacovigilance System, is a pharmacovigilance database in Spain which was developed in 1982. Pharmacovigilance FDA Adverse Event Reporting System (FAERS) Montero...

(2019). "Comparison of Quetiapine Abuse and Misuse Reports to the FDA Adverse Event Reporting System With Other Second-Generation Antipsychotics". Substance...

highest number of reported cases of serious injury among regularly monitored medications to the FDA's Adverse Events Reporting System (AERS). In October...

patients. In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User...

now FDA-approved indication. Even after approval, the FDA CDER continues to do postmarking surveillance of the drug through MedWatch and FDA Adverse Event...

Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)". FDA. 3 January 2023. Archived from the original on 28 February...

Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)". FDA. Doraiswamy PM, Xiong GL (2006). "Pharmacological strategies...