Webinar: Building a Culture of Quality: The Leadership Imperative for Operational Excellence

Register Now

Discover your potential savings with our ROI Calculator

Calculate ROI now
  FDA Adverse Event Reporting System

FDA Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS)

Protect public health with the FDA Adverse Event Reporting System, ensuring swift action through timely tracking and reporting of adverse events.

Request Demo
FDA Adverse Event Reporting System (FAERS)
FDA Adverse Event Reporting System Video

What is the FDA Adverse Event Reporting System?

The FDA Adverse Event Reporting System is a database that includes reports of adverse events, medication errors, and product quality complaints that lead to adverse events, all of which have been submitted to the FDA.

These reports are used to track adverse events and medication errors related to prescription and over-the-counter drugs, biologics, medical devices, and dietary supplements.

FAERS plays a vital role in post-market surveillance, helping the FDA identify safety concerns, unusual side effects, and emerging drug and product safety trends. This data-driven system is used by the regulatory body to monitor and maintain the ongoing safety of medical products on the market. It also supports international collaboration and research efforts while promoting transparency and public access to de-identified data.

Request Pricing

The FDA Adverse Event Reporting System is a useful tool for the 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 with 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 a lack of expected effectiveness
  • From accidental or intentional overdose
  • From drug or product withdrawal
  • From excessive use or abuse of the product

All adverse events and medication errors are coded based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The 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 the FDA can do so using the online reporting form instead of expecting the healthcare provider to report to the FDA. The report will include personal information about the consumer, product details, problem or reaction, and any other medical treatments or outcomes. To submit voluntary adverse event reports, consumers can follow any of the following methods:

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

Related Assets

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 the FDA Adverse Event Reporting System, further evaluation is performed. Based on the evaluation, the 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:

  • Over-the-Counter (OTC) and other human prescription drugs
  • Medical devices
  • Radiation-emitting electronic devices
  • Vaccines
  • Veterinary products
  • Tobacco products

Request an Online Demo
why FDA adverse event reporting system
Ultimate Investment

Understanding All About the FDA Inspection

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). These reports can be submitted by:

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

Further, manufacturers can receive reports from consumers and healthcare professionals. If a manufacturer receives 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

  • Food

  • Combination products

  • Medical devices

  • Special nutritional products

  • Biologics

  • Prescriptions or over-the-counter medications



Case study

Customer Success

Ingredient Innovator Launches Document Management Solution to Catapult Quality and Sales Processes

Case study
Read Case Study
Roles of FDA Adverse Event Reporting System in Organizations

Roles of the FDA Adverse Event Reporting System in Organizations

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

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

Contact Us

Powerful, Complete eQMS

We conducted a thorough, comparative review of systems within our budget and CQ was a clear winner. The system is powerful and versatile, even with an out of box implementation. The functionality is complete, covering every significant aspect of a quality system. Validation is straightforward with the use of OQ scripts from CQ, which can be modified to fit your implementation. It ensures that processes implemented through the system and records generated by the system are compliant for medical device companies. But, the biggest benefit we’ve received is through the collaborative partnership with CQ personnel. They listen and understand our needs. They are creative in helping us make implementation as easy as possible. Having been in large companies and small, I can see this system fitting in either environment and budget.

Jackie Jaskula,
Director of QA and Regulatory

origen logo
origen logo

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 the FDA Adverse Event Reporting System 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

Ensure compliance and protect patient safety by streamlining your reporting with the FDA Adverse Event Reporting System, designed to simplify adverse event documentation and submission.

Request an Online Demo

Quality-centric Companies Rely on CQ QMS

  • Flex
  • continental
  • 3m logo
  • YKK
  • Qorvo
  • Canon
  • Stryker
  • Lam Research
  • Just Evotech

Frequently Asked Questions

  • 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.

  • MedWatch is the FDA’s tool for submitting adverse event reports. FAERS is the database where those reports are stored and analyzed to monitor product safety.

Mascot Astronut

Related Insights

The Merger of ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices – Proposed Changes and Implications
Blog | April 4th, 2025

The Merger of ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices – Proposed Changes and Implications

In 2018, the US FDA had announced its plans to harmonize FDA Quality System Regulations (QSR) with ISO 13485:2016 quality…

View All Resources

Connect with a CQ Expert

Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.

Mascot

Please confirm your details

In Need of Smarter Ways Forward? Get in Touch.

Get a Demo Today
×
spinner
Consult Now

Comments