tranexamic acid
Risk of Medication Errors Due to Incorrect Route of Administration
Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally via the neuraxial route.
Package inserts
Additional information
10/21/2025:
FDA is requiring the following changes to the prescribing information for tranexamic acid injection:
- Add a Boxed Warning to communicate the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection
- Add a statement to indicate that tranexamic acid injection is contraindicated as a neuraxial injection
- Update the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution
Additionally, FDA is recommending that the container labels for tranexamic acid injection prominently display the product name and intravenous route of administration.
Keywords: Cyklokapron
Updated: February 2026