TACROLIMUS
Details
- Status
- Prescription
- First Approved
- 2009-08-10
- Routes
- ORAL, INJECTION, TOPICAL
- Dosage Forms
- CAPSULE, INJECTABLE, OINTMENT, CAPSULE, EXTENDED RELEASE
TACROLIMUS Approval History
What TACROLIMUS Treats
18 FDA approvalsOriginally approved for its first indication in 2009 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Aug 2009)Label Letter
- • Approved indication (May 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Aug 2011)
- • Approved indication (Sep 2012)
- • Approved indication (Jul 2014)
- • Approved indication (Sep 2014)Letter
- • Approved indication (Aug 2017)Letter
- • Approved indication (Nov 2017)
- • Approved indication (Apr 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Nov 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Apr 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Feb 2025)
TACROLIMUS Boxed 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 f...
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 )
TACROLIMUS Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TACROLIMUS FDA Label Details
ProIndications & Usage
FDA Label (PDF)Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact [see Clinical Studies , ] . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophyla...
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 o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.