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The Adverse Event Reporting System (AERS) is a computerized information database designed to support
the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic
products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur
with these marketed products.
Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some
adverse event and medication error reports directly from health care professionals (such as physicians,
pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
Healthcare professionals and consumers may also report these events to the products¶ manufacturers. If a
manufacturer receives an adverse event report, it is required to send the report to FDA as specified by
regulations. The MedWatch site provides information about mandatory reporting.
The structure of AERS is in compliance with the international safety reporting guidance (ICH E2B ) issued by
the International Conference on Harmonisation. Adverse events in AERS are coded to terms in the Medical
Dictionary for Regulatory Activities terminology (MedDRA).
AERS is a useful tool for FDA, which uses it for activities such as looking for new safety concerns that might
be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and
responding to outside requests for information. The reports in AERS are evaluated by clinical reviewers in
the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) to monitor the safety of products after they are approved by FDA. If a potential safety concern is
identified in AERS, further evaluation might include epidemiological studies. Based on an evaluation of the
potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public
health, such as updating a product¶s labeling information, restricting the use of the drug, communicating
new safety information to the public, or, in rare cases, removing a product from the market.
AERS data do have limitations. First, there is no certainty that the reported event was actually due to the
product. FDA does not require that a causal relationship between a product and event be proven, and
reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive all
adverse event reports that occur with a product. Many factors can influence whether or not an event will be
reported, such as the time a product has been marketed and publicity about an event. Therefore, AERS
cannot be used to calculate the incidence of an adverse event in the U.S. population.
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Y AERS Data Files
Y AERS Statistics
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Y MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Y ºoluntary Reporting to FDA:
èY Reporting by Consumers
èY Reporting by Health Professionals
Y Mandatory Reporting by Drug/Biologics Manufacturers, Distributors, and Packers
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(As of March 31, 2010)
The Adverse Event Reporting System (AERS) contains over four million reports of adverse events and
reflects data from 1969 to the present. Data from AERS are presented here as summary statistics. These
summary statistics cover data received over the last ten years. These data are presented at the individual
report level; some of the numbers may reflect duplicate reporting due to factors such as follow-up reports
received on a case or different persons reporting on the same patient case. We will update these data files
each quarter; therefore, the most recent year displayed may contain only partial year data.
Y Reports Received and Reports Entered into AERS by Year
Number of reports received by FDA and entered into AERS by type of report since the year 2000.
Y Domestic and Foreign Reports by Year
Number of domestic (U.S.) and foreign reports in AERS since the year 2000.
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(As of March 31, 2010) Back to AERS 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 AERS database. Not all of the reports that FDA receives for drug and
therapeutic biologic products are entered into the AERS database. At the present time, we are entering
reports of the following types:
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Y Reports submitted directly to FDA (not submitted through manufacturers)
Y Reports submitted on 3500A (or CIOMS) forms by manufacturers that are categorized as:
èY 15-day reports
èY serious Periodic reports, or
èY nonserious Periodic reports for new molecular entity (NME) products within the first 3 years following
FDA approval
Y Reports submitted electronically by manufacturers regardless of category.
A manufacturer's 15-day report is a report that contains at least one event that is not currently described in
the product labeling and the patient outcome is serious. A manufacturer's Periodic report is a report that did
not meet the criteria for a 15-day report. Manufacturers submit Periodic reports to FDA quarterly for newer
drugs (FDA-approved for three years or less) and annually for older drugs.
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2000 142,818 53,190 4,344 200,352
2001 134,363 65,939 3,983 204,285
2002 114,929 69,098 2,015 186,042
2003 151,041 75,005 171 226,217
2004 186,679 86,098 824 273,601
2005 219,463 102,221 1,700 323,384
2006 228,444 106,657 2,054 337,155
2007 236,112 125,017 3,320 364,449
2008 287,028 149,033 5,316 441,367
2009 300,901 178,406 11,528 490,836
2010 (Q1) 84,947 47,420 3,868 136,235
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(As of March 31, 2010) Back to AERS Statistics Main Page
These data describe information about the reporter ± the person who submitted the report to FDA, or the
person who submitted the report to the manufacturer (who then sent the report to FDA). Physicians and
pharmacists are the healthcare providers (HCP) who submit reports to FDA most frequently. ü
include nurses, dentists and others.
refers to any reporter who is not
documented in the report as a healthcare provider. This figure includes only data where reporter information
is known, and some adverse event reports may contain more than one reporter.
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The following reports list any potential signals of serious risks/new safety information that were identified
using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean
that FDA has concluded that the drug has this listed risk. It means that FDA has identified a
, but does not mean that FDA has identified a causal relationship between the drug and the
listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may
take a variety of actions including requiring changes to the labeling of the drug, requiring development of a
Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential signal of a serious risk/new safety
information on this Web site does not mean that FDA is suggesting that healthcare providers should not
prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have
questions about their use of the identified drug should contact their health care provider.
FDA will complete its evaluation of each potential safety issue and may issue additional public
communications as appropriate.
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FDA is posting these reports in accordance with Title IX, Section 921 of the Food and Drug Administration
Amendments Act of 2007 (FDAAA; see insert). FDA will publish a new list of potential signals of serious
risks/new safety information identified each quarter.
The table in each report lists the names of products and potential safety issues that were entered into the
above CDER or CBER tracking systems where the AERS database identified (or contributed to identification
of) the potential safety issues. Additional information on each issue is also provided.
A new report will be made available each quarter showing newly identified potential signals of serious
risks/new safety information identified from the AERS database during the previous quarter. Information
from previous quarters will remain available with updates on the Web site.
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-Y
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This page provides drug and therapeutic biological product manufacturers, distributors, packers, and other
interested parties with information about FDA Adverse Event Reporting System (AERS) electronic
submissions and instructions on how to electronically submit postmarketing individual case safety reports
(ICSRs), with and without attachments.
Since 2000, FDA has accepted ICSRs electronically. Currently, FDA only accepts electronic submissions of
ISCRs in the XML format, prepared in accordance with International Conference on Harmonisation-E2B (ICH
E2B) (PDF - 266KB), for direct database-to-database transmission of information using standardized (ICH
E2B(M)) data elements. FDA encourages electronic submissions of ICSRs because it is a cost-effective,
efficient alternative to paper-based reporting that allows for harmonized reporting among applicants
worldwide.
FDA will not accept ICSRs that are submitted electronically in formats other than XML. Please note that
attachments to ICSRs, however, are submitted electronically in formats other than XML. Sections 1-3 below
provide more detailed information on the electronic submission of ICSRs and ICSR attachments as well as
links to reference documents.
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The only permissible format for the electronic submission of ICSRs is the XML format. XML requires
specialized formatting using a standard structure. See document ³a
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(PDF - 84KB) XML files are submitted to the FDA via
the Electronic Submissions Gateway (ESG).
èY To electronically submit ICSR attachments through the 4, see Electronic Submissions Gateway.
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Format is Periodic Adverse (Drug) Experience Report1, or the ICH-E2C Periodic Safety Update
Report (allowed with approved waiver)
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Submitted either electronically using ICH E2B standards submitted on paper using FDA Form 3500A
(if you are not yet ready to submit electronically)
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0' , you can submit the descriptive portion electronically or
on paper.
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Use Electronic Common Technical Document (eCTD), specifications, module 5.3.6 for electronic
submission of the descriptive portion. Indicate in the descriptive portion that the ICSRs have been
submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).
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Mail two copies of paper submissions of the descriptive portion to the Central Document Room (CDR) at
the following address, and indicate in the descriptive portion of your Periodic report that the ICSRs have
been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).