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...
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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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Pharmacovigilance (redirect from Adverse event reporting)
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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Cetirizine (section Adverse effects)
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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Levofloxacin (section Adverse effects)
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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Gadodiamide (section Adverse effects)
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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SGLT2 inhibitor (section Adverse effects)
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...
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patients. In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User...
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Rivaroxaban (section Adverse effects)
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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Dapagliflozin (section Adverse effects)
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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Quetiapine (section Adverse effects)
(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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Dapagliflozin/metformin (section Adverse effects)
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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Quinolone antibiotic (redirect from Adverse effects of fluoroquinolones)
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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Farmacovigilancia Española, Datos de Reacciones Adversas (redirect from Spanish pharmacovigilance system)
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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