Skin Hypersensitivity to Oral Budesonide: Case Report and Review of the FDA Adverse Event Reporting System Database

2018 ◽  
Vol 52 (10) ◽  
pp. 1049-1050 ◽  
Author(s):  
Amichai Perlman ◽  
Alexander Maly ◽  
Zvi Ackerman
Keyword(s):  
Adverse Event ◽  
Case Report ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Skin Hypersensitivity ◽  
System Database

scholarly journals Combining big data search analytics and the FDA Adverse Event Reporting System database to detect a potential safety signal of mirtazapine abuse

2020 ◽  
Vol 26 (3) ◽  
pp. 2265-2279 ◽  
Author(s):  
Dimitrios Spachos ◽  
Spyridon Siafis ◽  
Panagiotis Bamidis ◽  
Dimitrios Kouvelas ◽  
Georgios Papazisis
Keyword(s):  
Adverse Event ◽  
Odds Ratio ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Safety Signal ◽  
Event Reporting ◽  
System Database ◽  
Potential Safety ◽  
Different Sources

This study sought to detect a potential safety signal of mirtazapine abuse by combining two different sources of surveillance, specifically Google Analytics (Google, Inc., Mountain View, CA, USA) and the FDA Adverse Event Reporting System database. Data from the first quarter of 2004 to the second quarter of 2017 were collected and analysed. The search interest over time, the frequencies of abuse-related terms in the search analytics domain, and the odds ratio of abuse events in FDA Adverse Event Reporting System were determined. Correlations between the two aforementioned domains using quarterly data from the timeline series were also assessed. Our results suggest a positive correlation between abuse-related searches in the Google domain and abuse-related events in FDA Adverse Event Reporting System database. These results indicate that these methods can be used in combination with each other as a pharmacovigilance supplementary tool to detect drug safety signals.

scholarly journals PUK3 DRUG-INDUCED ACUTE RENAL FAILURE USING THE FDA ADVERSE EVENT REPORTING SYSTEM DATABASE

2011 ◽  
Vol 14 (3) ◽  
pp. A74
Author(s):  
A.M. Alhammad ◽  
M.A. Al Hawaj ◽  
A.J. Alsalman ◽  
Y.N. Alhashem ◽  
S.E. Harpe ◽  
...  
Keyword(s):  
Renal Failure ◽  
Adverse Event ◽  
Acute Renal Failure ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Induced ◽  
Event Reporting ◽  
System Database
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