Risk Evaluation and Mitigation Strategies (REMS)

NOTICE — May 20, 2025: HHS modified this webpage pursuant to Executive Order 14168, but has reevaluated this webpage for purposes of compliance with Executive Order 14168, the Paperwork Reduction Act, the Information Quality Act, and the Foundations of Evidence-Based Policymaking Act of 2018. Based on that evaluation, HHS is temporarily restoring the information on this page as it existed on January 31, 2025, with certain modifications to account for new and amended Risk Evaluation and Mitigation Strategies (REMS) that were approved between January 31, 2025, and the present. Although HHS did not conclude that modification of this website was inconsistent with any of the aforementioned statues, HHS is providing notice of anticipated changes. After a period of at least two weeks from the date of this notice, information on this page will be modified and/or removed.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.

REMS are not designed to mitigate all the adverse events of a medication, these are communicated to health care providers in the medication’s prescribing information. Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.

REMS in Action: An Example

Here is one example of a product that has a serious risk and a REMS. The set of REMS requirements were designed to make sure all patients receive special monitoring during the period when a side effect is most likely to occur so it can be detected and treated:

Zyprexa Relprevv REMS

Zyprexa Relprevv is a long-acting injectable anti-psychotic medication used to treat schizophrenia in adults. Zyprexa Relprevv can cause serious reactions following injection called post-injection delirium sedation syndrome. Symptoms, including feeling sleepier than usual (sedation), coma, and feeling confused or disoriented (delirium) occurred in clinical studies within 3 hours after treatment with Zyprexa Relprevv. The risk of post-injection delirium sedation syndrome is present with every injection, although it is a small risk – less than 1 percent.

To reduce the risk of post-injection delirium sedation syndrome, FDA required the manufacturer of Zyprexa Relprevv to develop a REMS. The purpose of the REMS is to ensure that the drug is administered only in certified health care facilities that can observe patients for at least three hours and provide the medical care necessary in case of an adverse event.