Tacrolimus
Tacrolimus is an immunosuppressant medication used to prevent organ rejection after transplantation and to treat moderate to severe atopic dermatitis when other treatments haven't worked. It works by suppressing the immune system's activity to reduce inflammation and prevent rejection of transplanted organs.
An immunosuppressant used to prevent transplant rejection and treat severe eczema by inhibiting immune cell activity.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- D11AH01
- RxNorm
- 42316
- Generic
- Tacrolimus
- Class
- atc-d11
- Brands
- Astagraf, Envarsus, Prograf
- Availability
- rx
- Lactation
- unknown
- Routes
- oral, topical
- Forms
- injection, tablet, capsule, ointment, suspension
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 0.1-0.2 mg/kg/day
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.3 mg/kg/day
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.1 mg/kg/day
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; consider switching to alternative immunosuppressant if planning pregnancy
regular fetal monitoring including ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second third trimestermaintain therapeutic levels with close monitoring
continue therapy if needed for maternal graft survival; do not discontinue without physician consultation
monitor tacrolimus blood levels, fetal growth, and maternal blood pressure
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed while taking tacrolimus due to significant infant exposure risk
not applicable - breastfeeding should be avoided
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
pediatric liver transplantweight-based dosing at 0.15-0.20 mg/kg/day in two divided doses
used for prophylaxis of liver transplant rejection; requires careful dose titration
frequent blood level monitoring, assessment of renal function, and growth development monitoring
Use with caution and monitor for adverse effects.
pediatric_age
pediatric kidney transplantinitial dose 0.15 mg/kg/day in two divided doses
used in pediatric kidney transplant patients; combine with corticosteroids
regular monitoring of tacrolimus trough levels, renal function, and blood glucose
Use with caution and monitor for adverse effects.
geriatric
elderlystart at lower end of dosing range
use with caution due to increased susceptibility to adverse effects; consider dose reduction
closely monitor renal function, blood pressure, and neurological status
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderatereduce initial dose and monitor levels closely
use with caution; start at lower doses and titrate based on therapeutic drug monitoring
frequent monitoring of renal function and tacrolimus blood levels
Use with caution and monitor for adverse effects.
renal_impairment
severesignificant dose reduction required; typical reduction 25-50%
use only when benefits outweigh risks; requires intensive monitoring
very close monitoring of renal function and drug levels; consider alternative therapy if possible
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderatereduce dose as needed based on blood levels
adjust dosing based on hepatic function and therapeutic drug monitoring
monitor liver function tests and tacrolimus blood levels closely
Use with caution and monitor for adverse effects.
hepatic_impairment
severesignificant dose reduction and close monitoring required
use with extreme caution in severe hepatic impairment; consider dose reduction up to 50%
frequent monitoring of liver function tests and tacrolimus trough levels
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
First FDA approval for transplant rejection prevention
Drug class
Immunosuppressive drug classification
Common uses
Primary therapeutic applications
Brand names
Common commercial names
Prevention of organ rejection in liver, kidney, and heart transplants; treatment of moderate to severe atopic dermatitis ( eczema) in adults and children who haven't responded to other treatments.
Binds to an intracellular protein (FKBP-12) forming a complex that inhibits calcineurin, an enzyme essential for activating T-cells. This suppresses the immune response that would otherwise attack transplanted organs or cause inflammatory skin conditions.
Increases risk of infections and certain cancers due to immunosuppression. Requires regular blood monitoring to ensure proper dosing. Available in both oral and topical formulations. May interact with other medications that affect liver enzymes.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy