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What is FAERS?

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What is FAERS?

Where FAERS data come from?

FDA Adverse Event Reporting System (FAERS)

FAERS is a database that contains information on adverse event and medication error reports submitted to FDA. It contains over 9 million reports of adverse events from 1969 to the present.

How did FDA collected this data?

Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from healthcare professionals and consumers.

How many reports (aka Cases) received by FDA from 2006 to 2015?

FAERS YEAR Expedited DIRECT Non Expedited Entered Total Entered Non Expedited Received Total Received
2006 219,217 20,979 95,555 335,751 230,065 470,261
2007 229,982 23,032 110,405 363,419 228,206 481,220
2008 274,281 32,896 132,690 439,867 218,205 525,382
2009 330,383 34,165 126,177 490,725 216,264 580,812
2010 409,547 28,946 234,646 673,169 320,341 758,834
2011 499,155 28,045 255,275 782,475 346,745 873,945
2012 577,852 29,026 326,637 933,515 475,993 1,082,871
2013 635,206 28,386 411,622 1,075,214 506,512
1.170,104
2014 746,584 34,246 423,855 1,204,685 508,303 1,289,133

Number of Adverse Event Reports Entered into FAERS

 

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