FDA Adverse Event Reporting System

FDA Adverse Event Reporting System (FAERS)

FDA adverse event reporting system (FAERS)
FDA adverse event reporting system (FAERS)

What is the FDA Adverse Event Reporting System?

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event reporting regulations, is designed specifically to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. FAERS database adopted an informatic structure based on the guidance issued by ICH E2B or International Conference on Harmonisation. All approved drugs adverse event reports must be submitted by the manufacturer to FAERS electronically using the ICH E2B XML format which replicates Form FDA 3500A.

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FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include:

  • Looking out for new safety concerns that might be related to a marketed product
  • Evaluating a manufacturer’s compliance to reporting regulations
  • Responding to outside requests for information

An adverse event can be defined as any side effect or unexpected experience witnessed by humans with the use of a drug or other therapeutic biologic, irrespective of its relation to the use of the product. An adverse event could occur:

  • with use in professional practice
  • due to lack of expected effectiveness
  • from accidental or intentional overdose
  • from drug or product withdrawal
  • from excessive use or abuse of product usage

All adverse events and medication errors are coded based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. FDA established FAERS to handle reports of the following nature:

  • Unexpected complications or side effects, including skin rashes to any serious complications
  • Defects or other quality problems as a result of product performance
  • Potentially avoidable mistakes that can be caused due to packaging or labels that look similar, or usage difficulty due to the presence of hard-to-read displays or controls
  • Food concerns, including allergic reactions or illness
  • Medical device therapeutic failures

Consumers who wish to report an adverse event to FDA can do so using the online reporting form insteading of expecting the healthcare provider to report to FDA. The report will include personal information about the consumer, product details, problem or reaction, and any other medical treatments or outcome. To submit voluntary adverse events reports, consumers can follow any of the following methods:

  • Online reports
  • Call FDA by telephone at 1-800-FDA-1088
  • Fax or email Consumer Reporting Form FDA 3500B
  • Reporting Form FDA 3500

Why FDA Adverse Event Reporting System

Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.

If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take regulatory action(s) to improve product safety and protect public health, such as:

  • Restricting the use of the drug
  • Updating a product’s labeling information
  • Communicating new safety information to the public
  • Removing a product from the market
  • Issuing new safety alerts
  • Inspecting the product manufacturer
  • Ordering further studies to demonstrate product safety

FDA regulates several products across industries. FAERS can be used to report any of the following products:

  • OTC and other human prescription drugs
  • Medical devices
  • Radiation emitting electronic devices
  • Vaccines
  • Veterinary products
  • Tobacco products
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Who can use the FDA Adverse Event Reporting System to submit a report?

    The reports submitted through FAERS are evaluated based on clinical reviewers’ various parameters in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FAERS reports can also be submitted online. Reports can be submitted to FAERS by:

  • Consumers, including patients, lawyers, family members
  • Manufacturers
  • Healthcare professionals, including nurses, physicians, and pharmacists

Further, manufacturers can receive reports from consumers and healthcare professionals. If a manufacturer is in receipt of such reports, they are required to send the report based on the regulations specified by the FDA.

FAERS reports can be submitted online, through a consumer reporting form such as FDA 3500B, or through telephone. Some of the FDA regulated products are:

  • Cosmetics

  • Combination products

  • Medical devices

  • Special nutritional products

  • Biologics

  • Prescriptions or over-the-counter medications

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roles of FDA adverse event reporting system in organizations

Roles of FDA Adverse Event Reporting System in Organizations

FAERS public dashboard is user-friendly as it offers data based on query in the form of information and charts. The data is also searchable based on product or timeframe. The data from FDA Adverse Event Reporting System (FAERS) is available readily to the public in various forms, including highly interactive web-based FAERS dashboard, extracted FAERS data files of individual case safety reports from FAERS database, and individual safety files that can be acquired through a Freedom of Information (FOI) request to FDA.

  • Monitor new events and medication error in new products
  • Measure harm from medications
  • Ascertain the risk-benefit ratio to determine the continuity of the drug
  • Monitor safety of product after FDA’s approval

ComplianceQuest and Salesforce
– a winning combination

ComplianceQuest pairs the user-friendly tools of SalesForce with a very capable and responsive development / support team resulting in a full QMS application that was adapted to our processes and very easy to implement. Our large, global organization is not an easy group to please. From their patient participation in our configuration workshops to their quick responses to every email and crazy request, the CQ team has proven to be a true partner in our implementation. Their website and demos show how user-friendly and well integrated the modules are. The REAL win is getting this functionality with a team who is truly invested and has gone over and above to make our implementation a success!

Melanie Lees,
Quality Director

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How to handle FAERS reports with ComplianceQuest?

FDA and ISO compliant environments are stringent about non-conformance of product, material, or component. Nonconformance and elimination of its cause are critical to an organization’s quality system. Failure to conform or report to FAERS can lead to costly rework or a product recall. With CQ Nonconformance Management Solution, companies can capture, triage, investigate and dispose of all non-conformances in a timely and effective manner. Our primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.

handle FAERS reports with ComplianceQuest

Using FAERS data to identify, capture, prioritize, investigate and resolve all non-conformances in an efficient manner to reduce COQ capture and take action on non-conformances before it leaves the organization with CQ's non-conformance management solution

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Frequently Asked Questions

  • Identifying and managing product and process Nonconformance and eliminating its cause is critical to an organization’s quality system. This is especially pertinent in the stringent FDA and ISO-compliant environments, where a non-conforming product, material, or component could lead to costly rework, or worse, a product recall. CQ’s primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.

    • Reduce CoQ due to internal failures with a collaborative approach to nonconformance management, organization can prevent any variance to process, parts, or equipment and ensure periodic training of shop floor workers to align to the ever-changing quality parameters.

    • Leverage Einstein predictive analytics to spot nonconformance trends and draw insights from data, escalate to a CAPA ahead of time and drive Continuous Improvement (CI) of the entire quality management process.

    • Catch nonconformance early before it reaches a customer and prevents a potential injury for the end-user, avoid unnecessary penalties/fines and protect brand image.

    • With robust process control to reduce quality gaps and conform to product specifications, attain greater customer satisfaction by reducing client objections.

    • CQ’s EQMS automates ISO and FDA-compliance using a risk-based approach to prioritize nonconformances and initiate corrections.

    • Using an integrated Risk Management Module, automate nonconformance management workflows to identify, document, and prevent nonconformances, with a specific focus on high-risk nonconformances to minimize risk.

  • An adverse event is any unintented experience a patient encounter upon using a medical product. Some of the most prominent ones include death, life-threatening symptoms, disability or permanent damage, hospitalization, or congenital anomaly. FDA recommends patients and medical device users to report these cases to take action.


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