Black Box Warning
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsulest or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] Increased mortality in female liver transplant patients with tacrolimus extended-release capsulest. Tacrolimus extended-release capsulest is not approved for use in liver transplantation. [see Warnings and Precautions ( 5.3 )] WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; and INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with with tacrolimus extended-release capsules or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) Increased mortality in female liver transplant patients with with tacrolimus extended-release capsules. Not approved for use in liver transplantation. ( 5.3 )
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Tacrolimus.