Tacrolimus: uses, dosing, side effects & brands
Tacrolimus is a calcineurin inhibitor immunosuppressant sold in the U.S. under 5 brand and generic names, for atopic dermatitis and graft vs host disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Calcineurin Inhibitor Immunosuppressant
- Treats (across its forms)
- Atopic Dermatitis and Graft Vs Host Disease
- Available as
- Capsule · Powder · Injectable · Capsule, extended release · Tablet, extended release · Topical
- Sold as
- 5 products — Prograf, Astagraf XL and Envarsus XR, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $0.65 per gm — not your price
- Boxed warning
- Boxed warning
How Prograf is dosed
From the FDA label for Prograf (application NDA210115). Other tacrolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Intravenous (IV) use recommended for patients who cannot tolerate oral formulations (capsules or suspension). ( 2.1 , 2.2 ) • Administer capsules or suspension consistently with or without food. ( 2.1 ) • Therapeutic drug monitoring is recommended. ( 2.1 , 2.6 ) • Avoid eating grapefruit or drinking grapefruit juice. ( 2.1 ) • See dosage adjustments for African-American patients ( 2.2 ), hepatic and renal impaired. ( 2.4 , 2.5 ) • For complete dosing information, see Full Prescribing Information. ADULT Patient Population Initial Oral Dosage (formulation) Whole Blood Trough Concentration Range Kidney Transplant With azathioprine 0.2 mg/kg/day capsules, divided in two doses, every 12 hours Month 1-3: 7-20 ng/mL Month 4-12: 5-15 ng/mL With MMF/IL-2 receptor antagonist 0.1 mg/kg/day capsules, divided in two doses, every 12 hours Month 1-12: 4-11 ng/mL Liver Transplant With corticosteroids only 0.1-0.15 mg/kg/day capsules, divided in two doses, every 12 hours Month 1-12: 5-20 ng/mL Heart Transplant With azathioprine or MMF 0.075 mg/kg/day capsules, divided in two doses, every 12 hours Month 1-3: 10-20 ng/mL Month ≥ 4: 5-15 ng/mL Lung Transplant With azathioprine or MMF 0.075 mg/kg/day Patients with cystic fibrosis may require higher doses due to lower bioavailability. capsules, divided in two doses, every 12 hours Month 1-3: 10-15 ng/mL Month 4-12: 8-12 ng/mL PEDIATRIC Patient…
Everything below is the FDA label for Prograf (capsule, powder, injectable). Tacrolimus is also sold as capsule, extended release, tablet, extended release and topical, and those are different medicines to take — follow the label for the one you were prescribed.
Prograf side effects
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Lymphoma and Other Malignancies [see Warnings and Precautions ( 5.1 )] • Serious Infections [see Warnings and Precautions ( 5.2 )] • New Onset Diabetes After Transplant [see Warnings and Precautions ( 5.4 )] • Nephrotoxicity [see Warnings and Precautions ( 5.5 )] • Neurotoxicity [see Warnings and Precautions ( 5.6 )] • Hyperkalemia [see Warnings and Precautions ( 5.7 )] • Hypertension [see Warnings and Precautions ( 5.8 )] • Anaphylactic Reactions with PROGRAF Injection [see Warnings and Precautions ( 5.9 )] • Myocardial Hypertrophy [see Warnings and Precautions ( 5.13 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.15 )] • Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions ( 5.16 )] The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at…
Who shouldn’t take Prograf
PROGRAF is contraindicated in patients with a hypersensitivity to tacrolimus. PROGRAF injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see Adverse Reactions ( 6 )] . • Hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil). ( 4 )
Prograf drug interactions
Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to PROGRAF; monitor for MPA-related adverse reactions and adjust MMF or MPA dose as needed. ( 7.1 ) • Nelfinavir and Grapefruit Juice: Increased tacrolimus concentrations via CYP3A inhibition; avoid concomitant use. ( 7.2 ) • CYP3A Inhibitors: Increased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. ( 5.11 , 7.2 ) • CYP3A4 Inducers: Decreased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. ( 5.11 , 7.2 ) • Therapeutic drug monitoring and dose reduction for PROGRAF should be considered when PROGRAF is co-administered with cannabidiol ( 5.17 , 7.3 ). 7.1 Mycophenolic Acid When PROGRAF is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with PROGRAF co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA-associated adverse reactions and reduce the dose of concomitantly administered mycophenolic acid products as needed. 7.2 Effects of Other Drugs on PROGRAF Table 15 displays the effects of other drugs on PROGRAF. Table 15. Effects of Other Drugs/Substances on PROGRAF PROGRAF dosage adjustment recommendation based on observed effect of co-administered drug on tacrolimus exposures [see Clinical Pharmacology ( 12.3 )] , literature reports of altered tacrolimus exposures, or the other drug’s known CYP3A inhibitor/inducer status. Drug/Substance Class or Name Drug Interaction Effect Recommendations Grapefruit or grapefruit juice High dose or double strength grapefruit juice is a strong CYP3A inhibitor; low dose or single strength grapefruit juice is a moderate CYP3A inhibitor. May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.6 , 5.11 , 5.12 )] . Avoid grapefruit or grapefruit juice. Strong CYP3A Inducers Strong CYP3A inhibitor/inducer, based on reported effect on exposures to tacrolimus along with supporting in vitro CYP3A inhibitor/inducer data, or based on drug-drug interaction studies with midazolam (sensitive CYP3A probe substrate). : Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions ( 5.11 )] . Increase PROGRAF dose and monitor tacrolimus whole blood trough concentrations [see Dosage and Administration ( 2.2 , 2.6 ) and Clinical Pharmacology ( 12.3 )] . Strong CYP3A Inhibitors : Protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, letermovir, Schisandra sphenanthera extracts May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation). A rapid, sharp rise in tacrolimus levels may occur early, despite an immediate reduction of tacrolimus dose [see Warnings and Precautions ( 5.6 , 5.11 , 5.12 )] . Reduce PROGRAF dose (for voriconazole and posaconazole, give one-third of the original dose) and adjust dose based on tacrolimus whole blood trough concentrations [see Dosage and Administration ( 2.2 , 2.6 ) and Clinical Pharmacology ( 12.3 )] . Early and frequent monitoring of tacrolimus whole blood trough levels should start within 1-3 days and continue monitoring as necessary [see Warnings and Precautions ( 5.11 )]. Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., erythromycin, fluconazole), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.6 , 5.11 , 5.12 )] . Monitor tacrolimus whole blood trough concentrations and reduce PROGRAF dose if needed [see Dosage and Administration ( 2.2 , 2.6 ) and Clinical Pharmacology ( 12.3 )] . Other drugs, such as: Magnesium and aluminum hydroxide antacids Metoclopramide May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.6 , 5.11 , 5.12 )] . Monitor tacrolimus whole blood trough concentrations and reduce PROGRAF dose if needed [see Dosage and Administration ( 2.2 , 2.6 ) and Clinical Pharmacology ( 12.3 )] . Mild or Moderate CYP3A Inducers Methylprednisolone, prednisone May decrease tacrolimus whole blood trough concentrations. Monitor tacrolimus whole blood trough concentrations and adjust PROGRAF dose if needed [see Dosage and Administration ( 2.2 , 2.6 )] . Caspofungin May decrease tacrolimus whole blood trough concentrations. Monitor tacrolimus whole blood trough concentrations and adjust PROGRAF dose if needed [see Dosage and Administration ( 2.2 , 2.6 )] . Direct Acting Antiviral (DAA) Therapy The pharmacokinetics of tacrolimus may be impacted by changes in liver function during DAA therapy, related to clearance of HCV virus. Close monitoring and potential dose adjustment of PROGRAF is warranted to ensure continued efficacy and safety [see Dosage and Administration ( 2.2 , 2.6 )] . 7.3 Cannabidiol The blood levels of tacrolimus may increase upon concomitant use with cannabidiol. When cannabidiol and PROGRAF are co-administered, closely monitor for an increase in tacrolimus blood levels and for adverse reactions suggestive of tacrolimus toxicity. A dose reduction of PROGRAF should be considered as needed when PROGRAF is co-administered with cannabidiol [see Dosage and Administration ( 2.2 , 2.6 ) and Warnings and Precautions ( 5.17 ) ] .
Tacrolimus and food
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗
Every tacrolimus product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Capsule | Generic | $1 | View → | |
| 3 | Not yet rated | Prescription | Tablet | Generic | $1 | View → | |
| 4 | Not yet rated | Prescription | Topical | Generic | $1 | View → | |
| 5 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
What tacrolimus pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| G;686 | 1 mg | white, white | capsule | — |
| 0;5MG;RDY525 | 0.5 mg | yellow | capsule | — |
| 5MG;RDY527 | 5 mg | red | capsule | — |
| G;685 | 0.5 mg | yellow, yellow | capsule | — |
| G;686 | 1 mg | white, white | capsule | — |
| Biocon;logo;T;0;5 | 0.5 mg | yellow | capsule | — |
| Bioconlogo;T;1 | 1 mg | white | capsule | — |
| Biocon;logo;T;5 | 5 mg | gray | capsule | — |
| SAL;720 | 0.5 mg | red | capsule | — |
| SAL;721 | 1 mg | green | capsule | — |
| SAL;722 | 5 mg | blue | capsule | — |
| G;687 | 5 mg | red, red | capsule | — |
Tacrolimus recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Prograf (tacrolimus) capsules
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Can you crush or split tacrolimus?
At least one tacrolimusproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each tacrolimus label says about crushing, splitting and chewingTacrolimus and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for tacrolimus: levels in milk, effects in breastfed infants, and the drugs it would consider insteadThe amounts of systemically administered tacrolimus are low in breastmilk and do not adversely affect the breastfed infant. Tacrolimus has been used extensively by nursing mothers and United States and European experts guidelines consider tacrolimus to be acceptable during breastfeeding. Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern.
National Institute of Child Health and Human Development, record revised March 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about tacrolimus
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 130,930 reports naming tacrolimus, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- acute kidney injury5,469 reports
- diarrhoea4,753 reports
- transplant rejection4,189 reports
- cytomegalovirus infection4,140 reports
- pyrexia4,014 reports
- covid-193,757 reports
- pneumonia3,719 reports
- sepsis2,973 reports
Read these as a signal, not a rate. A report does not mean tacrolimus caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related guides
Related calculators
Frequently asked questions
What is Prograf?
Prograf (Tacrolimus) is a calcineurin inhibitor immunosuppressant used to treat Atopic Dermatitis, Graft Vs Host Disease.
What kind of drug is tacrolimus?
The FDA classifies tacrolimus as a calcineurin inhibitor immunosuppressant. Calcineurin inhibitors block an enzyme called calcineurin inside immune T-cells, which stops the cells from making interleukin-2 and other signaling chemicals. This keeps T-cells from activating and multiplying, dialing down the immune attack that drives organ rejection or autoimmune disease. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take tacrolimus with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tacrolimus against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is tacrolimus sold under?
We track 5 tacrolimus-containing products in the U.S.: Prograf, Astagraf XL, Envarsus XR, Protopic and Tacrolimus. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does tacrolimus come in?
Across the brands we track, tacrolimus is currently marketed as capsule, powder, injectable, capsule, extended release, tablet, extended release and topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tacrolimus?
Yes. Our catalog lists 1 generic tacrolimus product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has tacrolimus been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions tacrolimus. The most recent: Astagraf XL (tacrolimus extended-release capsules) 0.5 mg (Dec 23, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
What should I avoid while taking tacrolimus?
Food: grapefruit and grapefruit juice (and, for some drugs, seville oranges) — see the food section above for what each one does and whether it means avoiding it or just being consistent. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tacrolimus: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tacrolimus
- MLA
- “Tacrolimus: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tacrolimus.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tacrolimus on DailyMed (NIH) ↗ — including its boxed warning in full.