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  5. FDA's Adverse Event Reporting System (FAERS)
  6. Reports Received and Reports Entered into FAERS by Year
  1. FDA's Adverse Event Reporting System (FAERS)

Reports Received and Reports Entered into FAERS by Year

(As of November 2015)

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These data describe total numbers of reports we received for drugs and therapeutic biologic products and the number of reports we entered into the FAERS database. Not all of the reports that FDA receives for drug and therapeutic biologic products are entered into the FAERS database. At the present time, we are entering reports of the following types:

  • Reports submitted directly to FDA (not submitted through manufacturers)
  • Reports submitted on 3500A (or CIOMS) paper forms by manufacturers that are categorized as:
    • expedited reports
    • non-expedited reports of serious adverse events, or
    • non-expedited reports of non-serious adverse events, for new molecular entity (NME) products within the first 3 years following FDA approval
  • Reports submitted electronically by manufacturers regardless of category.

A manufacturer's expedited report is a report that contains at least one adverse event that is not currently described in the product labeling and for which the patient outcome is serious. A manufacturer's non-expedited report is a report that did not meet the criteria for an expedited report.  Manufacturers submit non-expedited reports to FDA quarterly for the first three years after approval, and annually thereafter.

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Figure 1. This figure illustrates the number of reports received (solid bars) and entered (checkered bars) into AERS by type of report since the year 2006 through the first quarter of 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
2015(Q1) 227,347 9,824 181,856 419,027 203,442 440,613
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