Adverse Event Reporting System (AERS) AERS Description

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.AERS Data

AERS Data Files

AERS Statistics How to Report Adverse Events

MedWatch : The FDA Safety  Information and Adverse Event Reporting Program

o Voluntary Reporting to FDA:

Reporting by Consumers

Reporting by Health Professionals

o Mandatory Reporting by Drug/Biologics Manufacturers, Distributors, and Packers

Adverse Event Reporting System (AERS) Statistics(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.

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.

Domestic and Foreign Reports by YearNumber of domestic (U.S.) and foreign reports in AERS since the year 2000.

Reporting by Healthcare Providers and Consumers by YearNumber of reports in AERS by type of reporter (Healthcare Professional [HCP] or consumer) since the year 2000.

Patient Outcomes by YearPatient outcome(s) for reports in AERS since the year 2000. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

    Reports Received and Reports Entered into AERS by Year(As of March 31, 2010) Back to AERS Statistics Main PageThese 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:

o Reports submitted directly to FDA (not submitted through manufacturers)

o Reports submitted on 3500A (or CIOMS) forms by manufacturers that are categorized as:

15-day reports

serious Periodic reports, or

nonserious Periodic reports for new molecular entity (NME) products within the first 3 years following FDA approval

o 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.

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 2000 until the end of the first quarter of 2010.

This table represents the number of reports received by FDA and entered into AERS by type of report since the year 2000 until the end the third quarter of 2009.

Year Direct 15-day PeriodicReceived

PeriodicEntered

TotalReceived

TotalEntered

2000 16,131 94,931 155,804 89,290 266,866 200,352

2001 19,308 114,693 150,761 70,284 284,762 204,285

2002 20,438 128,680 173,375 36,924 322,493 186,042

2003 22,944 144,271 203,628 59,002 370,843 226,217

2004 21,655 162,007 239,268 89,939 422,930 273,601

2005 25,312 213,324 225,183 84,748 463,819 323,384

2006 20,977 219,956 230,461 96,222 471,394 337,155

2007 23,033 230,919 228,202 110,497 482,154 364,449

2008 32,899 275,421 218,207 133,047 526,527 441,367

2009 34,173 330,476 216,255 126,186 580,904 490,835

2010 (Q1) 8,177 91,459 57,411 36,599 157,077 136,235

    AERS Domestic and Foreign Reports by Year(As of March 31, 2010) Back to AERS Statistics Main PageThese data describe the geographic source of report. Domestic means that the reporter's country is the United States. Foreign means that the reporter's country is outside the United States. Unknown means that there were no data in the report that documented the geographic source of the report.

This figure illustrates the number of domestic (U.S.) and foreign reports in AERS since the year 2000 until the end of the first quarter of 2010.

This table represents the number of domestic (U.S.) and foreign reports in AERS since the year 2000 until the end of the first quarter of 2010.

Year Domestic Foreign UnknownTotal

Entered

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

AERS Reporting by Healthcare Providers and Consumers by Year(As of March 31, 2010) Back to AERS Statistics Main PageThese 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. Other Healthcare Providers include nurses, dentists and others. Consumerrefers 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.

This figure illustrates the number of reports in AERS by type of reporter (Healthcare Professional [HCP] or consumer) since the year 2000 until the end of the first quarter of 2010. 

 

This table represents the number of reports in AERS by type of reporter (Healthcare Professional [HCP] or consumer) since the year 2000 until the end of the first quarter of 2010.

YearHealthcare Provider:Physician

Healthcare Provider:

Pharmacist

OtherHealthcare Provider

TotalHealthcare Provider

Consumer

2000 59,090 18,794 20,191 98,075 46,249

2001 66,001 19,050 23,685 108,736 39,517

2002 67,967 17,184 27,944 113,095 30,282

2003 79,793 19,410 39,392 138,595 48,352

2004 92,737 20,329 46,056 159,122 74,644

2005 106,362 21,540 43,820 171,722 105,308

2006 113,444 21,512 49,827 184,783 127,475

2007 121,000 21,343 60,343 202,686 174,216

2008 154,044 27,070 88,651 269,765 226,647

2009 177,861 29,208 110,815 317,884 272,989

2010 (Q1) 49,680 7,734 34,825 92,239 70,033

    AERS Patient Outcomes by Year(As of March 31, 2010) Back to AERS Statistics Main PageThese data describe the outcome of the patient as defined in U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80) and Forms FDA 3500 and 3500A (the MedWatch forms).Serious means that one or more of the following outcomes were documented in the report: death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome. Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of these outcomes.

This figure illustrates the patient outcome(s) for reports in AERS since the year 2000 until the end of the first quarter of 2010. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

This figure illustrates the patient outcome(s) for reports in AERS since the year 2000 until the end of the first quarter of 2010. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

Year Death Serious

2000 19,445 153,818

2001 23,988 166,384

2002 28,181 159,000

2003 35,173 177,008

2004 34,928 199,510

2005 40,238 257,604

2006 37,465 265,130

2007 36,834 273,276

2008 49,958 319,741

2009 63,846 373,535

2010 (Q1) 20,619 100,903

    Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)

What is FDA Posting?

Why is FDA posting this information?

How was the list generated?

What information is provided?

Quarterly Reports  

What is FDA posting? 

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 potential safety issue, 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.

Why is FDA posting this information? 

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.

 Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962) amends the Federal Food, Drug and Cosmetic Act (FDCA) to add a new subsection (k)(5) to section 505 (21 U.S.C. 355).This section in FDAAA, among other things, directs FDA to "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the

Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter." When a potential signal of a serious risk is identified from AERS data, it will be posted in the required report in the quarter in which it is first identified. A potential signal of a serious risk may in some cases constitute new safety information as defined in FDAAA (newly created section 505-1(b)(3) of the FDCA) which includes, among other things, information derived from adverse event reports about a serious risk associated with use of a drug that FDA has become aware of since the drug was approved or, for drugs that have REMS, since the REMS was required or last assessed. FDA will post each potential signal of a serious risk in the quarter in which it is first identified. If additional new safety information is developed concerning a potential signal that has already been posted, it will be addressed by FDA in new safety communications, but will not appear again as a new quarterly posting.

 

How was the list generated? 

FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER's Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.

What information is provided? 

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.

Quarterly Reports    

-

2010

January – March 2010 (Updated)  

April - June 2010 (New!)  --

2009

January - March 2009 (Updated)  

April - June 2009 (Updated)  

July - September 2009 (Updated)  

October – December 2009 (Updated)

Adverse Events Reporting System (AERS) Electronic SubmissionsThis 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.

1. Electronic Submission of ICSRs: Format

o XML is the only acceptable format.

The only permissible format for the electronic submission of ICSRs is the XML format.  XML requires specialized formatting using a standard structure. See document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments"(PDF - 84KB). XML files are submitted to the FDA via the Electronic Submissions Gateway (ESG). 

 

o For instructions on the steps to take to begin submitting ICSRs in the XML format, please see:  "Steps to Submitting ICSRs Electronically in the XML Format."

 

2. Electronic submission of Attachments to ICSRs 

o Attachments to ICSRs may be submitted either on physical media or through the ESG.

To electronically submit ISCR attachments on physical media, see page 8 of the document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (PDF - 84KB).

 

To electronically submit ICSR attachments through the ESG, see Electronic Submissions Gateway.

 

o What is considered to be an ICSR attachment?

Attachments to ICSRs include supporting information for ICSRs such as relevant hospital discharge summaries and autopsy reports/death certificates and published articles for ICSRs based on scientific literature.

 

3. Submission of Periodic reports:  Electronic versus Paper

Periodic reports have the following parts; each part may be submitted electronically or on

paper. 

o Descriptive portion:Format is Periodic Adverse (Drug) Experience Report1, or the ICH-E2C Periodic Safety Update Report (allowed with approved waiver) 

 

o Individual case safety reports (ICSRs), with or without attachments:

Submitted either electronically using ICH E2B standards or submitted on paper using FDA Form 3500A (if you are not yet ready to submit electronically)

 

A.  If you are submitting ICSRs electronically, you can submit the descriptive portion electronically or on paper.

o Electronic submission of descriptive portion

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).

 

o Paper submission of descriptive portion

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).

FDA/Central Document Room5901-B Ammendale Rd.Beltsville, MD  20705-1266

 

B.  If you are submitting ICSRs on paper (Form FDA 3500A), because you are not yet ready to submit ICSRs electronically, and you are

 

o Submitting the descriptive portion of your Periodic electronically

Mail two copies of the ICSRs (i.e. two complete sets of the paper 3500A forms) to the CDR at the address above.

Add to the CDR address: Attn: AERS 3500A Reports Production.

Indicate in the electronically submitted descriptive portion of the Periodic report that you have submitted (mailed) the ICSRs (paper 3500A forms) to the CDR.

     Submission of ICSRs to the eCTD  (e.g. PDFs of FDA Form 3500A) will not be accepted.

o Submitting the descriptive portion of your Periodic on paper

Attach the ICSRs (3500A forms) to the descriptive portion.

Mail two copies of the descriptive portion with attached ICSRs to the CDR at the address above.