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U.S. Department of Health and Human Services

Drugs

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Reports Received and Reports Entered into FAERS by Year

(As of June 30, 2012)Back to FAERS Statistics Main Page

These data describe total numbers of reports 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) forms by manufacturers that are categorized as:
    • expedited reports
    • non-expedited reports of serious adverse events, or
    • nonserious, non-expedited reports 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 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 newer drugs (FDA-approved for three years or less) and annually for drugs that have been approved for more than three years.


This figure illustrates the number of reports received (solid bars) and entered (checkered bars) into FAERS by type of report since the year 2003 until the end of the second quarter of 2012.


Number of reports received and entered into FAERS by type of report since the year 2000. Corresponding data appear in the accompanying table.


This table represents the number of reports received by FDA and entered into FAERS by type of report since the year 2003 until the end of the second quarter of 2012.

AERS YearExpeditedDirectNon-Expedited
Entered
Total EnteredNon-Expedited RcvdTotal Rcvd
2003
143,670
22,942
58,615
225,227
203,628
370,240
2004
161,382
21,652
89,838
272,872
239,268
422,302
2005
212,137
25,306
84,486
321,929
225,183
462,626
2006
219,217
20,978
95,552
335,747
230,461
470,656
2007
230,000
23,034
110,403
363,437
228,202
481,236
2008
274,311
32,900
132,688
439,899
218,207
525,418
2009
330,418
34,171
126,183
490,772
216,255
580,844
2010
409,596
28,950
234,688
673,234
320,330
758,876
2011
499,528
28,062
255,143
782,733
346,526
874,116
2012 (Q2)
282,653
14,453
160,083
457,189
243,275
540,381