• 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...
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  • 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...
    14 KB (1,493 words) - 17:19, 25 June 2025
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    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...
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    Administration (FDA) is responsible for monitoring post-marketing studies. The FDA has a reporting system called the FDA Adverse Event Reporting System, where...
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  • of an adverse event, because they may result in an adverse drug reaction. The US FDA has long considered such criteria to conform to reportable and collectible...
    74 KB (9,355 words) - 18:59, 18 June 2025
  • 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...
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  • 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...
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    and Drug Administration (FDA) analyzed cases of pruritus after stopping cetirizine in the FDA Adverse Event Reporting System (FAERS) database and medical...
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    Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse...
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    "Investigation of cardiac arrhythmia events in patients treated with lamotrigine: FDA adverse event reporting system analysis". Epilepsia. 64 (9): 2322–2329...
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    gravis exacerbation: evaluation of postmarketing reports from the US FDA adverse event reporting system and a literature review". Drug Safety. 34 (10):...
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    studies have documented such events in patients who received gadodiamide. Data from the U.S. FDA Adverse Event Reporting System (FAERS) also list anaphylaxis...
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  • "FDA Adverse Events Reporting System (FAERS) - Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting...
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  • 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...
    48 KB (4,792 words) - 18:45, 13 June 2025
  • Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data". Drugs in R&D. 17 (1):...
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  • 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...
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  • Major adverse cardiovascular events (MACE, or major adverse cardiac events) is a composite endpoint frequently used in cardiovascular research. Despite...
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    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...
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  • Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the...
    32 KB (3,304 words) - 20:22, 24 June 2025
  • patients. In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User...
    36 KB (3,690 words) - 19:52, 29 May 2025
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    highest number of reported cases of serious injury among regularly monitored medications to the FDA's Adverse Events Reporting System (AERS). In October...
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    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...
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    Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)". FDA. Doraiswamy PM, Xiong GL (2006). "Pharmacological strategies...
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    (2019). "Comparison of Quetiapine Abuse and Misuse Reports to the FDA Adverse Event Reporting System With Other Second-Generation Antipsychotics". Substance...
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  • Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)". FDA. Archived from the original on 27 June 2023. Retrieved...
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    Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System". The International Journal of Neuropsychopharmacology. 25...
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    comprehensively reporting these findings. In particular, we identified quality concerns with MedWatch reports (the FDA's primary source of adverse event reports) and...
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    electronic health records and/or adverse event reports. Organizations such as the FDA Adverse Event Reporting System (FAERS) and the World Health Organization’s...
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    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...
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  • Pharmacovigilance System, is a pharmacovigilance database in Spain which was developed in 1982. Pharmacovigilance FDA Adverse Event Reporting System (FAERS) Montero...
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