Tacrolimus
Pronunciation: pronunciation varies by local usage.
- Generic name
- Tacrolimus
- Brand names
- Prograf, Astagraf XL, Envarsus XR
- Drug class
- Calcineurin inhibitor (immunosuppressant)
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What Tacrolimus is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
What Tacrolimus is used for
Prophylaxis of organ transplant rejection
Prevents the body’s immune system from rejecting a transplanted liver, kidney, heart, or lung, used together with other immunosuppressant medicines. (2)
Before taking Tacrolimus
Do not take / not appropriate for
- Do not take tacrolimus if you have ever had a hypersensitivity (allergic) reaction to tacrolimus or to any ingredient in the product. (all countries) (2)
- Tacrolimus injection must not be given to anyone who is hypersensitive to HCO-60 (polyoxyl 60 hydrogenated castor oil), the solubilising agent used in the injectable form. (all countries) (2)
- Do not take tacrolimus at the same time as cyclosporine. The label directs that one is stopped at least 24 hours before the other is started, and that dosing is delayed further if blood levels of either drug are still raised. (This appears in the label's warnings, not in its contraindications section.) (all countries)
Tell your clinician about
- Any allergy to tacrolimus, to castor-oil derivatives (HCO-60), or to any other medicine.
- Every other medicine you take, including cyclosporine, nelfinavir, and any other medicine that affects the CYP3A enzymes — these can raise or lower tacrolimus levels. Avoid grapefruit juice.
- Any history of infection, or of cancer including skin cancer: the boxed warning states that tacrolimus and other immunosuppressants increase the risk of serious infections and of malignancies such as lymphoma, which may lead to hospitalisation or death.
- Any kidney problems — tacrolimus can cause acute and chronic nephrotoxicity, and kidney function is monitored throughout treatment.
- Any nervous-system symptoms such as tremor, severe headache, confusion, visual changes, or seizures, which can signal neurotoxicity including posterior reversible encephalopathy syndrome (PRES).
- Diabetes or raised blood sugar — new-onset diabetes after transplant is a recognised risk and blood glucose is monitored.
- Pregnancy, plans for pregnancy, or breastfeeding.
How to take Tacrolimus
- General Instructions: Take tacrolimus exactly as prescribed by your transplant team, at the same times each day, consistently with or without food as instructed. This is a narrow-therapeutic-index medicine — blood levels are monitored regularly and the dose is set individually for you.. When To Seek Review: Contact your transplant team promptly if you notice signs of infection, reduced urination, tremor, severe headache, or any new symptom.. Storage: Store as directed on the pharmacy label, typically at room temperature, protected from light and moisture, out of reach of children.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, contact your transplant team or pharmacist for guidance rather than deciding on your own — timing matters for this narrow-therapeutic-index medicine. Do not take an extra dose to make up for a missed one.
Overdose
If overdose is suspected, contact your transplant team or emergency services immediately. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Tremor
What to notice: A common early side effect, often related to blood level.
What to do: Contact your transplant team if tremor is bothersome or worsening. (2)
Headache
What to notice: A common side effect.
What to do: Contact your transplant team if severe or persistent. (2)
Nausea and diarrhea
What to notice: Common gastrointestinal effects.
What to do: Contact your transplant team if severe, persistent, or affecting your ability to take the medicine. (2)
Elevated blood sugar
What to notice: Tacrolimus can raise blood sugar, sometimes causing new-onset diabetes after transplant.
What to do: Your transplant team monitors blood sugar regularly. (2)
Serious warnings
Serious infections and malignancies —
Action: Boxed warning: tacrolimus and other immunosuppressants increase the risk of serious infections and cancers (e.g. lymphoma, skin cancer), which can lead to hospitalization or death. Only a clinician experienced in transplant immunosuppression should manage this medicine.
Kidney problems (nephrotoxicity) —
Action: Contact your transplant team promptly if you notice reduced urination, swelling, or feel unusually unwell — blood levels and kidney function are monitored regularly.
Neurological symptoms (tremor, headache, confusion, seizures) —
Action: Contact your transplant team promptly if you develop tremor, severe headache, confusion, or seizures.
New-onset diabetes after transplant —
Action: Blood sugar is monitored regularly; contact your transplant team if you notice increased thirst, urination, or fatigue.
Allergic reaction —
Action: Seek immediate medical attention for swelling, difficulty breathing, or severe rash.
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Grapefruit and grapefruit juice | Can raise tacrolimus blood levels. | Avoid grapefruit and grapefruit juice. (2) |
| Live vaccines | Reduced vaccine effectiveness and increased infection risk during immunosuppression. | Avoid live vaccines; discuss any vaccination with your transplant team first. (2) |
| Other nephrotoxic or QT-prolonging medicines | May add to tacrolimus’s effect on the kidneys or heart rhythm. | Your transplant team reviews all your medicines and adjusts monitoring accordingly. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Requires a primary-source research pass before this section can be completed. (2)
Breastfeeding
Requires a primary-source research pass before this section can be completed. (2)
Children
Frequency: Approved for pediatric transplant patients, dosing set by the transplant team.. Weight Based: Yes, pediatric dosing is weight-based.. Max Daily Dose: Determined individually by the transplant team.. Max Single Dose: Determined individually by the transplant team.. Age Restrictions: Approved for pediatric liver, kidney, heart, and lung transplant recipients per the US label. (2)
Renal_impairment
Requires a primary-source research pass before this section can be completed. (2)
Hepatic_impairment
Requires a primary-source research pass before this section can be completed. (2)
Monitoring
(2)Storage
Follow the exact product label and keep medicines away from children.
Clinician-facing summary
Clinician-facing context only.
General
Indication: Prophylaxis of organ transplant rejection
Dose summary: Dose is individualized by the transplant team and adjusted to a target whole-blood trough level — there is no fixed standard dose; typical liver-transplant IV starting doses are 0.03-0.05 mg/kg/day, lung-transplant IV 0.01-0.03 mg/kg/day or oral 0.075 mg/kg/day divided every 12 hours.
Renal context: Tacrolimus is potentially nephrotoxic itself; the transplant team monitors kidney function and blood tacrolimus levels closely and adjusts the dose accordingly. No separate fixed renal-impairment dose table is published — dosing is individualized. (2)
Frequently asked questions
What is Tacrolimus used for?
Tacrolimus is used to prevent the body’s immune system from rejecting a transplanted liver, kidney, heart, or lung. It is always used together with other immunosuppressant medicines and is prescribed and monitored by a transplant specialist.
What are the side effects of Tacrolimus?
Common side effects include nausea, headache, tremor, and changes in blood pressure or blood sugar. Because tacrolimus has a narrow therapeutic index, your transplant team monitors your blood levels and kidney function regularly. Contact them promptly for reduced urination, swelling, confusion, or severe headache.
How should I take Tacrolimus?
Take tacrolimus exactly as prescribed by your transplant team, at the same times each day, consistently with or without food as instructed. Never adjust the dose yourself — blood levels are checked regularly and the dose is set individually for you.
What is the generic name of Tacrolimus?
The generic name is Tacrolimus. It is sold under brand names including Prograf, Astagraf XL, Envarsus XR.
What class of drug is Tacrolimus?
Tacrolimus is classed as: Calcineurin inhibitor (immunosuppressant).
References
- Tacrolimus — Prescribing InformationDailyMed · United States · dated unknown · accessed 2026-08-07 · source 1
- PROGRAF (tacrolimus) capsule/injection/granule — Prescribing Information (DailyMed)DailyMed / authoritative reference · United States · accessed 2026-08-08 · source 2
- TACROLIMUS CAPSULE [MAJOR PHARMACEUTICALS] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Tacrolimus — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- tacrolimus — FDA approval record (Drugs@FDA ANDA215012)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- Tacrolimus — RxNorm normalized drug concept (RXCUI 42316)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient Tacrolimus names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Prograf.2 mg, .5 mg, 5 mg, 1 mg, 5 mg/mL · astellas pharma us, inc.
- Envarsus XR4 mg, .75 mg, 1 mg · veloxis pharmaceuticals, inc
- ASTAGRAF XL.5 mg, 5 mg, 1 mg · astellas pharma us, inc.
Canada
- PROGRAF
- ADVAGRAF
- PROTOPIC