New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
[Formerly FDA Adverse Event Reporting System (FAERS)]
FDA Adverse Event Monitoring System (AEMS)
FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines.
This unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance.
Beyond adverse event reporting, AEMS will serve as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers. This comprehensive approach will enable more effective safety monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities.
- What information is FDA posting?
- Why is FDA posting this information?
- How was the report generated?
- What information is provided?
- Quarterly Reports
- Why is FDA posting a quarterly report outside of the usual timeframe?
- Archived Quarterly Reports
What information is FDA posting?
FDA is posting a report of new safety information or potential signals of serious risks that were identified during the surveillance of postmarking data in the FAERS database in the respective quarter. This report applies to human prescription and nonprescription drug and biological products. The appearance of a drug or biological product on a quarterly report does not mean that FDA has concluded that the drug or biological product has the listed risk or that FDA has identified a causal relationship between the drug or biological product and the listed risk at the time the report is posted. The appearance of drug or biological product on a quarterly report means that FDA has identified a potential safety signal and is evaluating the signal. If after further evaluation the FDA determines that the drug or biological product is associated with the risk, FDA may take a variety of actions, including requiring changes to the product labeling, requiring development or modification of a risk evaluation and mitigation strategy (REMS), or gathering additional data to better characterize the risk. FDA may also issue public communications about the safety signal, as appropriate.
FDA wants to emphasize that the listing of a drug or biological product associated with new safety information or a potential signal of a serious risk on this webpage does not mean that FDA has determined that the drug or biological product has the risk. FDA is not suggesting whether healthcare providers should prescribe the drug or biological product or that patients should stop taking the medication while an evaluation of the potential safety signal is being conducted. Patients who have questions about their use of the identified drug or biological product should contact their health care provider.
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. FDA will publish a new report of new safety information or potential signals of serious risks identified each quarter.
Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to add 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."
In 2016, section 3075 of the 21st Century Cures Act amended section 505(k)(5) of the FD&C Act to strike “bi-weekly screening” as required by FDAAA, and inserted “screenings”; it also added the requirement that FDA make available on its internet website the following: (i) guidelines, developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that detail best practices for drug safety surveillance using the Adverse Event Reporting System; and (ii) criteria for public posting of adverse event signals. Data from AERS was moved to FAERS for the launch of FAERS on September 10, 2012. Data from FAERS was moved to AEMS for the launch of AEMS on March 11, 2026.
When a potential signal of a serious risk is identified from AEMS 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 FD&C Act) which includes, among other things, information derived from adverse event reports about a serious risk or unexpected serious risk associated with use of a drug that FDA has become aware of since the drug was approved or, for drugs that have risk evaluation and mitigation strategy (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 and will not appear again as a new quarterly posting.
How was the report generated?
FDA staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) regularly examine the FAERS database as part of routine safety monitoring. When new safety information or a potential signal of a serious risk is identified from FAERS data, it is entered in the CDER or CBER tracking system.
What information is provided?
The table in each quarterly report lists the names of drug and biological products and potential safety signals that were identified in FAERS and entered into the CDER or CBER tracking systems. The listed products may also include generic drug product(s) and biosimiliar or interchangeable biosimilar biological product(s), as appropriate. Additional information on each potential safety signal is provided to inform the public of FDA regulatory actions or communications, such as an FDA Drug Safety Communication, or actions taken by an applicant. The “as of” date in the “Additional Information” column in the report refers to the date that additional information was updated to describe the action FDA took after the evaluation of the safety signal was completed or action was taken by the applicant.
A new report will be made available each quarter describing new safety information or potential signals of serious risk identified in FAERS during the previous quarter. Information from earlier quarters will remain available on this webpage until the evaluation of the potential safety signal is completed and action has been taken by FDA or the applicant. FDA actions may include a determination either that a) the drug is not associated with the risk and therefore no regulatory action is required, or b) the drug may be associated with the risk, and one of the following is required: a modification to the product labeling; development or modification of a REMS; marketing suspension or withdrawal; or gathering additional data to characterize the risk. After FDA has determined that no regulatory action is necessary or has taken a regulatory action for each potential signal on a quarterly report, no further updates will be communicated in the quarterly report and it will be archived.