Health advisory: Be Alert for Serious Adverse Events After Ceftriaxone Administration

| March 13, 2025

This is a Provider Alert from the Washington State Department of Health (WA DOH) related to reports of severe adverse events, including cardiac arrest and death, after administration of ceftriaxone.

On February 7, 2025, the CDC issued a call for cases related to a small number (approximately 10) of severe adverse events closely following ceftriaxone injection or infusion, dating from Sept. 1, 2024 to present.

There are no single product types or lots identified with these severe events. While there is no confirmed causal link to ceftriaxone, a public health investigation is underway to identify and characterize these serious adverse events.

CURRENT SITUATION

WA DOH has not received reports of any cases in Washington of severe adverse events after ceftriaxone administration.

However, we are asking for providers to be on alert for these severe reactions and report them as detailed below. WA DOH will share information about severe events that match the below criteria with CDC in a de-identified manner.

ACTIONS REQUESTED

1. Healthcare providers should report any severe adverse events that meet ALL of the following criteria:

  • Severe reaction requiring cardiopulmonary resuscitation (CPR)* OR resulting in death, AND
  • Occurring within 6 hours of receipt of injectable ceftriaxone** in a non-ICU setting, AND
  • Not attributed by the treating provider(s) to a cause other than ceftriaxone
    administration***.

* cardiopulmonary resuscitation defined as the use of chest compressions and mechanical ventilation or provision of rescue breaths to maintain circulatory flow and oxygenation during cardiac arrest

** including both intramuscular and intravenous routes of administration

*** such as known infection, other underlying medical condition, or exposure to a medication or medical product other than ceftriaxone


2. Report cases to WA DOH and FDA’s MedWatch Program:

  • Cases of severe events after ceftriaxone administration that have occurred between September 1, 2024 through present can be reported to WA DOH:
  • Do not report cases of allergic reactions; only report severe events as described above.
  • Providers should also report severe adverse events associated with ceftriaxone, or any other drug or medical device, to FDA’s MedWatch Program.


3. If a SEVERE reaction occurs, facilities should consider the following:

  • If there is any residual open product linked to a severe reaction, sequester this product for potential testing.
  • If no residual product is available, consider setting aside a sample of product from the same lot number for future testing.


4. Providers are encouraged to discuss ceftriaxone use in their facility, and have a plan to respond to allergic reactions including anaphylaxis and other severe reactions discussed here.

BACKGROUND

Ceftriaxone (sold under the trade name Rocephin®) is an injectable cephalosporin antibiotic that is used in both outpatient and inpatient settings. It is used to treat common conditions such as gonorrhea and other bacterial infections.

As with any injectable antibiotic, allergic reactions can occur, and measure should be taken to monitor and respond appropriately to such reactions. Cephalosporins, such as ceftriaxone, can cause allergic reaction in 0.5% to 2.5% of patients.

CONTACT

To report suspected cases, or for any other questions, please contact the WA DOH Healthcare Associated Infections Program at: