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Tacrolimus

Tacrolimus is an immune-suppressing medicine used mainly to help prevent organ rejection after kidney, liver, heart or lung transplants, and (as an ointment) to treat moderate to severe atopic dermatitis (eczema).

Brand names Astagraf XlEnvarsus XRPrografAstagrafEnvarsus
Drug classes Calcineurin Inhibitor Immunosuppressant
Rx Forms 7
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Class I recall on record · 3
Other forms & routes:
Injection Topical
Tacrolimus at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tacrolimus, a calcineurin inhibitor that blocks an enzyme immune T-cells need to switch on and multiply, anchors most anti-rejection regimens after kidney, liver, heart or lung transplants and, as an ointment, treats moderate to severe eczema; on the market since about 1994, it is available generically. Most people tolerate it reasonably well, though hand tremor, headache, tingling and poor sleep are common. The boxed warning is serious, possibly fatal, infections and cancers such as lymphoma and skin cancer, so report fever, swollen glands or new skin spots quickly and use sunscreen. Regular blood tests check its level, kidneys, sugar and potassium, and the dose is adjusted to match.

Clinical pearls

  • Immediate-release and extended-release versions are not interchangeable, so speak up if a refill looks different from your last one.
  • Take immediate-release forms consistently with or without food each day; extended-release forms go once daily on an empty stomach.
  • Avoid grapefruit in any form, St John's Wort and CBD products, which can push levels too high or too low.
  • Tell every prescriber you take tacrolimus; voriconazole, clarithromycin and rifampin can shift levels enough to need dose changes.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Tacrolimus raises your risk of serious infections and of cancers, including lymphoma and skin cancer. These problems can lead to hospitalization or death. The risk is linked to how strong and how long the immune suppression is. Watch for fever, signs of infection, new skin changes or swollen glands, and tell your doctor right away. Use sun protection.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Topical cream, ointment or gel, Extended-release capsule +4
Earliest FDA record1994
Companies listing it with the FDA36
FDA label last updatedAug 25, 2023
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Tacrolimus, written from its FDA label.

What Tacrolimus is used for

▾

Tacrolimus is used in several forms, and each product has its own approvals.

  • Prograf (capsules, oral suspension, injection): prevents organ rejection in adults and children receiving kidney, liver, heart or lung transplants.
  • Tacrolimus capsules and injection (generic): prevent rejection in kidney, liver or heart transplants. Some generic capsule labels also include lung transplant and children.
  • Astagraf XL and tacrolimus extended-release capsules: prevent rejection in kidney transplants for people who can swallow capsules whole.
  • Envarsus XR extended-release tablets: prevent rejection in new kidney transplants and in kidney patients switched from immediate-release tacrolimus.
  • Tacrus and tacrolimus ointment: treat moderate to severe atopic dermatitis (eczema) when other treatments have not worked or are not suitable.

How Tacrolimus works

▾

Tacrolimus attaches to a protein inside immune cells called FKBP-12. This blocks calcineurin, an enzyme that T-cells need to become active. As a result, the cells make fewer immune signaling chemicals (cytokines), and T-cell activation and growth are reduced.

The net effect is immune suppression, which helps keep the body from attacking a transplanted organ.

Tacrolimus dosage

▾

Dose and schedule depend on the product, your transplant type and your blood levels. Follow your prescriber and your label.

  • Immediate-release capsules and suspension: taken about every 12 hours, the same way each day with or without food.
  • Astagraf XL and tacrolimus extended-release capsules: swallowed whole once each morning on an empty stomach.
  • Envarsus XR: taken once daily on an empty stomach, preferably in the morning.
  • Injection: given into a vein, usually when oral forms cannot be tolerated.
  • Ointment: a thin layer on affected skin.

Regular blood tests guide dose changes. Avoid grapefruit.

Dosing details from the FDA-approved label

From the Tacrolimus prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult Kidney Transplant with azathioprine (Prograf capsules)
    • 0.2 mg/kg/day capsules, divided in two doses, every 12 hours
    • Whole blood trough Month 1-3: 7-20 ng/mL; Month 4-12: 5-15 ng/mL
  • Adult Kidney Transplant with MMF/IL-2 receptor antagonist (Prograf capsules)
    • 0.1 mg/kg/day capsules, divided in two doses, every 12 hours
    • Whole blood trough Month 1-12: 4-11 ng/mL
  • Adult Liver Transplant with corticosteroids only (Prograf capsules)
    • 0.1-0.15 mg/kg/day capsules, divided in two doses, every 12 hours
    • Whole blood trough Month 1-12: 5-20 ng/mL
  • Adult Heart Transplant with azathioprine or MMF (Prograf capsules)
    • 0.075 mg/kg/day capsules, divided in two doses, every 12 hours
    • Whole blood trough Month 1-3: 10-20 ng/mL; Month ≥ 4: 5-15 ng/mL
  • Adult Lung Transplant with azathioprine or MMF (Prograf capsules)
    • 0.075 mg/kg/day capsules, divided in two doses, every 12 hours
    • Patients with cystic fibrosis may require higher doses due to lower bioavailability
  • Pediatric Kidney Transplant (Prograf)
    • 0.3 mg/kg/day capsules or oral suspension, divided in two doses, every 12 hours
    • Whole blood trough Month 1-12: 5-20 ng/mL
  • Pediatric Liver Transplant (Prograf)
    • 0.15-0.2 mg/kg/day capsules or 0.2 mg/kg/day oral suspension, divided in two doses, every 12 hours
    • Whole blood trough Month 1-12: 5-20 ng/mL
  • Pediatric Heart Transplant (Prograf)
    • 0.3 mg/kg/day capsules or oral suspension, divided in two doses, every 12 hours
    • Dose at 0.1 mg/kg/day if antibody induction treatment is administered
  • Pediatric Lung Transplant (Prograf)
    • 0.3 mg/kg/day capsules or oral suspension, divided in two doses, every 12 hours
    • Whole blood trough Weeks 1-2: 10-20 ng/mL; Week 2 to Month 12: 10-15 ng/mL
  • Adult Kidney Transplant with basiliximab, MMF and steroids (Astagraf XL)
    • 0.15 to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant
    • Take every morning on an empty stomach; trough Month 1: 7-15 ng/mL
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • 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 Population Initial Oral Dosage (formulation) Whole Blood Trough Concentration Range Kidney Transplant 0.3 mg/kg/day capsules or oral suspension, divided in two doses, every 12 hours Month 1-12: 5-20 ng/mL Liver Transplant 0.15-0.2 mg/kg/day capsules or 0.2 mg/kg/day oral suspension, divided in two doses, every 12 hours Month 1-12: 5-20 ng/mL Heart Transplant 0.3 mg/kg/day Dose at 0.1 mg/kg/day if antibody induction treatment is administered. capsules or oral suspension, divided in two doses, every 12 hours Month 1-12: 5-20 ng/mL Lung Transplant 0.3 mg/kg/day , capsules or oral suspension, divided in two doses, every 12 hours Weeks 1-2: 10-20 ng/mL Week 2 to Month 12: 10-15 ng/mL MMF= Mycophenolate mofetil 2.1 Important Administration Instructions PROGRAF should not be used without supervision by a physician with experience in immunosuppressive therapy.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Tacrolimus side effects

▾

Common side effects include:

Common side effects

  • Tremor (shaking)
  • Headache
  • High blood pressure
  • Diarrhea, nausea or constipation
  • Trouble sleeping
  • Abnormal kidney function or raised creatinine
  • Tingling or numbness (paresthesia)
  • High blood sugar, high potassium or low magnesium

When to get medical help

  • Signs of infection, such as fever, chills or unusual tiredness, because serious and even fatal infections can occur
  • New or changing skin lesions, swollen glands or other possible signs of lymphoma or other cancers
  • Seizures, confusion, severe headache, vision changes or other new nerve or brain symptoms
  • Reduced urination or other signs of kidney problems
  • Increased thirst and urination, which can signal new diabetes
  • Rash, trouble breathing or swelling during or after the injection (possible anaphylaxis)
  • Fainting, a racing or irregular heartbeat, or dizziness (possible QT prolongation, a heart rhythm problem)
  • Unusual bruising, extreme paleness or tiredness, which can signal blood problems like pure red cell aplasia or thrombotic microangiopathy

Call your doctor promptly for signs of infection, seizures or confusion, reduced urination, a racing or irregular heartbeat, or allergic reactions.

Tacrolimus warnings and precautions

▾
  • Serious infections and cancers (boxed warning): Tacrolimus weakens the immune system, raising the risk of serious infections and lymphoma or skin cancers. Protect your skin from sun.
  • Kidney damage: Kidney function and blood levels are monitored.
  • Nerve problems: These range from tremor to seizures and a brain condition called PRES.
  • New diabetes, high potassium and high blood pressure: These need monitoring.
  • Heart rhythm changes (QT prolongation) and heart muscle thickening: Both are possible.
  • Allergic reactions: Anaphylaxis can occur with the injection.
  • Blood problems: Rare events include pure red cell aplasia and thrombotic microangiopathy.
  • Vaccines: Avoid live vaccines.
  • Product mix-ups: Immediate-release and extended-release forms are not interchangeable.

Tacrolimus interactions

▾

Many drugs and foods change tacrolimus levels, so tell your care team about everything you take.

  • Grapefruit and grapefruit juice: raise levels, so avoid them.
  • Strong CYP3A inhibitors such as ketoconazole, voriconazole, clarithromycin and ritonavir: raise levels and risk.
  • Strong inducers such as rifampin, phenytoin, carbamazepine and St John’s Wort: lower levels and raise rejection risk.
  • Calcium channel blockers, amiodarone, omeprazole and some antacids: may raise levels.
  • Cannabidiol: may raise levels.
  • Kidney-harming drugs: add to kidney risk.
  • Potassium-raising drugs such as ACE inhibitors, ARBs and potassium-sparing diuretics: add to high potassium risk.
  • Sirolimus: not recommended with tacrolimus in liver and heart transplants.
  • Mycophenolic acid products: exposure may be higher, so doses may need adjusting.

Interactions listed in the FDA-approved label

From the Tacrolimus prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Grapefruit or grapefruit juice: May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation). Avoid grapefruit or grapefruit juice.
  • Strong CYP3A inducers (rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, St John's Wort): May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection. Increase tacrolimus dose and monitor tacrolimus whole blood trough concentrations.
  • Strong CYP3A inhibitors (nelfinavir, telaprevir, boceprevir, ritonavir, voriconazole, posaconazole, itraconazole, ketoconazole, clarithromycin, troleandomycin, chloramphenicol, nefazodone, letermovir, schisandra sphenanthera extracts): May increase tacrolimus trough concentrations and the risk of serious adverse reactions; a rapid sharp rise may occur early despite immediate dose reduction. Reduce tacrolimus dose (for voriconazole and posaconazole, give one-third of the original dose) and adjust by trough concentrations; monitor levels within 1-3 days.
  • Mild or moderate CYP3A inhibitors (clotrimazole, erythromycin, fluconazole, verapamil, diltiazem, nifedipine, nicardipine, amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole, omeprazole): May increase tacrolimus whole blood trough concentrations and the risk of serious adverse reactions. Monitor tacrolimus whole blood trough concentrations and reduce tacrolimus dose if needed.
  • Magnesium and aluminum hydroxide antacids, metoclopramide: May increase tacrolimus whole blood trough concentrations and the risk of serious adverse reactions. Monitor tacrolimus whole blood trough concentrations and reduce tacrolimus dose if needed.
  • Mild or moderate CYP3A inducers (methylprednisolone, prednisone): May decrease tacrolimus whole blood trough concentrations. Monitor trough concentrations and adjust tacrolimus dose if needed.
  • Caspofungin: May decrease tacrolimus whole blood trough concentrations. Monitor trough concentrations and adjust tacrolimus dose if needed.
  • Mycophenolic acid products: MPA exposure is higher with tacrolimus than with cyclosporine, because cyclosporine interrupts enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA-associated adverse reactions and reduce the dose of the mycophenolic acid product as needed.
  • Cannabidiol: Tacrolimus blood levels may increase with concomitant use. Closely monitor for increased tacrolimus levels and toxicity; consider tacrolimus dose reduction as needed.
  • Direct acting antiviral (DAA) therapy: Tacrolimus pharmacokinetics may be impacted by changes in liver function during DAA therapy. Close monitoring and potential dose adjustment is warranted.
Read the label’s full interactions text

7 DRUG INTERACTIONS Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to tacrolimus; 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 tacrolimus should be considered when tacrolimus is co-administered with cannabidiol ( 5.17 , 7.3 ). 7.1 Mycophenolic Acid When tacrolimus is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with tacrolimus 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 Tacrolimus Table 15 displays the effects of other drugs on tacrolimus. Table 15: Effects of Other Drugs/Substances on Tacrolimus1 Drug/Substance Class or Name Drug Interaction Effect Recommendations Grapefruit or grapefruit juice2 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 Inducers3: 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.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿202 supplements and herbs with documented Tacrolimus interactions, ranked by severity Check Tacrolimus against a supplement or herb →

Before taking Tacrolimus

▾
  • Do not use if you are allergic to tacrolimus, or to HCO-60 for the injection.
  • Tell your doctor if you are pregnant or planning pregnancy. Tacrolimus can cause fetal harm, including prematurity and birth defects.
  • Breastfeeding: tacrolimus is present in breast milk, so discuss risks and benefits.
  • Fertility may be affected in men and women.
  • Tell your doctor about kidney, liver or heart rhythm problems, diabetes or high blood pressure.
  • Children: some products are approved for children, while others are not. Tacrolimus ointment is not for children under 2.
  • Ask about vaccines before starting.

Tacrolimus overdose

▾

Overdoses of up to 30 times the intended dose have been reported, and almost all were without symptoms. When symptoms occurred, they included tremor, kidney problems, high blood pressure and swelling. Treatment is general supportive care, so get medical help right away if you take too much.

What Tacrolimus does in the body

▾

Tacrolimus lowers the production of several immune signaling chemicals, including interleukins and interferon gamma. It reduces T-cell activation and growth and also dampens B-cell responses that depend on T-helper cells. This immune suppression is how it helps prevent rejection.

How your body processes Tacrolimus

▾

Oral absorption is incomplete and varies from person to person, with bioavailability of roughly 17% to 23% in adult transplant patients. Food lowers both how fast and how much is absorbed, so it is taken consistently each day. About 99% is bound to plasma proteins. Because of this variability, doses are individualized using whole blood trough levels.

How to store Tacrolimus

▾

Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) . Store and Dispense Store between 5°C and 25°C (41°F and 77°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

202

Supplements & herbs that interact with Tacrolimus

202 supplements and herbal products have documented interactions with Tacrolimus in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 152
  • Minor · 39
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major ASARABACCA Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major +194 more
Every supplement checked against Tacrolimus — ranked by severity The full interaction hub: 11 major · 152 moderate · 39 minor · every one linked to its full report. Check Tacrolimus against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Tacrolimus has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

MAGNESIUM Major Depletion
See the full Tacrolimus nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Tacrolimus: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Tacrolimus — the kind of thing our pharmacy team would talk through with you at the counter.

What is tacrolimus for?

▾
Most forms help prevent your body from rejecting a transplanted kidney, liver, heart or lung, always alongside other immune-suppressing medicines. Which organs are covered depends on the product. The ointment is different: it treats moderate to severe eczema when other skin treatments have not worked.

How should I take it?

▾
Take it the same way every day. Immediate-release capsules are taken consistently with or without food. Extended-release products are taken once daily on an empty stomach, and Astagraf XL capsules must be swallowed whole. Follow your label, and keep your blood-level tests.

Can I drink grapefruit juice?

▾
No. Grapefruit can raise tacrolimus levels and increase the risk of serious side effects. Avoid alcohol too if you take Astagraf XL, extended-release capsules or Envarsus XR.

What side effects are normal, and when should I call?

▾
Tremor, headache, diarrhea, nausea, trouble sleeping and high blood pressure are common. Call right away for fever or signs of infection, seizures or confusion, little urine, a fast or irregular heartbeat, new skin changes, or trouble breathing or rash during an injection.

Can I switch between brands or forms?

▾
Only if your doctor says so. Immediate-release and extended-release tacrolimus are not interchangeable, and mix-ups have caused rejection or toxicity. Check what your pills look like and ask your pharmacist if anything looks different.

Is it safe in pregnancy?

▾
Tacrolimus can harm an unborn baby, with risks like prematurity, low birth weight and birth defects. Talk to your doctor about family planning and contraception before you start, and tell them right away if you become pregnant. Do not stop it on your own.

Is Tacrolimus available over the counter?

▾
No. Tacrolimus is a prescription medicine: every Tacrolimus product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tacrolimus first available?

▾
The earliest FDA record we hold for Tacrolimus is from 1994: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tacrolimus was first used.

Who makes Tacrolimus?

▾
36 companies currently list Tacrolimus products in the FDA's NDC Directory, including Astellas Pharma US, Inc., Bryant Ranch Prepack, Accord Healthcare Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Tacrolimus on HelloPharmacist

📊Tacrolimus supplement interactions202 checked — ranked by severity 🌿Drug & Supplement CheckerTacrolimus vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Tacrolimus NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Tacrolimus Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tacrolimus forms and strengths (how it comes)

Tacrolimus is available in 7 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Prograf
How this form is used
What it may be used for
  • Prograf is used to prevent organ rejection in adults and children receiving kidney, liver, heart or lung transplants, with other immunosuppressants.
  • Tacrolimus capsules (some labels) are for kidney, liver or heart transplants, and other labels also include lung transplant.
Important instructions
  • Prograf capsules are taken consistently, either with or without food.
  • Avoid grapefruit and grapefruit juice with tacrolimus capsules.
  • Tacrolimus capsules are not interchangeable with extended-release tacrolimus products.
Available strengths 3 strengths
0.5 mg 1 mg 5 mg
197 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Protopic Tacrus
How this form is used
What it may be used for
  • Tacrus ointment treats moderate to severe atopic dermatitis (eczema) in adults, and in children 2 years and older (0.03% strength), when conventional therapies have not worked.
  • Tacrolimus ointment is second-line therapy for short-term and non-continuous long-term treatment of moderate to severe atopic dermatitis.
Important instructions
  • Tacrus is applied as a thin layer to affected skin, and should be kept out of eyes, nose and mouth.
  • Do not cover treated skin with bandages or wraps with Tacrus.
  • Tacrolimus ointment should not be used long-term continuously, and it should not be used with occlusive dressings.
  • Wash your hands after applying Tacrus unless they are also being treated.
Available strengths 2 strengths
0.3 mg/g 1 mg/g
21 FDA-listed product records ⓘ

Extended-release capsule

By mouth
Brands Astagraf Xl
How this form is used
What it may be used for
  • Astagraf XL is used to prevent organ rejection in kidney transplant patients, adults and children who can swallow capsules whole.
  • Tacrolimus extended-release capsules (generic) are used for kidney transplant in adults who can swallow capsules whole.
Important instructions
  • Astagraf XL capsules must be swallowed whole.
  • Astagraf XL is taken every morning at the same time on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Avoid grapefruit, grapefruit juice and alcohol with Astagraf XL.
Available strengths 3 strengths
0.5 mg 1 mg 5 mg
15 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Prograf
How this form is used
What it may be used for
  • Prograf is used to prevent organ rejection in adults and children receiving kidney, liver, heart or lung transplants.
Important instructions
  • Prograf suspension is taken consistently with or without food.
  • Avoid grapefruit and grapefruit juice with Prograf.
Available strengths 2 strengths
0.2 mg 1 mg
10 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Envarsus
How this form is used
What it may be used for
  • Envarsus XR is used to prevent organ rejection in new kidney transplant patients, with other immunosuppressants.
  • Envarsus XR is also used in kidney transplant patients switched from immediate-release tacrolimus.
Important instructions
  • Envarsus XR is taken once daily on an empty stomach at the same time each day, preferably in the morning.
  • Avoid grapefruit, grapefruit juice and alcohol with Envarsus XR.
  • Envarsus XR is not interchangeable with other tacrolimus products.
Available strengths 3 strengths
0.75 mg 1 mg 4 mg
9 FDA-listed product records ⓘ

Injection

Into a vein
Brands Prograf
How this form is used
What it may be used for
  • Prograf (injection and oral forms) is used to prevent organ rejection in kidney, liver, heart or lung transplants.
  • Tacrolimus injection is used for kidney, liver or heart transplants in adults and liver transplants in children.
Important instructions
  • Prograf injection is for people who cannot tolerate oral forms.
  • Tacrolimus injection should be switched to oral as soon as oral therapy is tolerated, to lower the risk of anaphylaxis.
  • Tacrolimus injection should be used under supervision of a physician experienced in immunosuppressive therapy.
Available strengths 1 strength
5 mg/mL
4 FDA-listed product records ⓘ

Tablet

By mouth
Available strengths 3 strengths
0.75 mg 1 mg 4 mg
3 FDA-listed product records ⓘ

Tacrolimus on the U.S. market: products, makers and brands

How Tacrolimus appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

36 companies list 106 Tacrolimus product records with the FDA, mostly as capsule, topical cream, ointment or gel, extended-release capsule; the earliest marketing or approval year on record is 1994. Brand names on the directory include Astagraf Xl, Envarsus XR, Prograf and 2 more; the rest are generics.

7
Dose forms ⓘ
36
Labelers (makers, repackagers, distributors)
5
Brand names
106
FDA-listed product records ⓘ
1994
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (29) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Astellas Pharma US, Inc.8%
Bryant Ranch Prepack6%
Accord Healthcare Inc.5%
Glenmark Pharmaceuticals Inc., USA5%
Ajenat Pharmaceuticals LLC3%
American Health Packaging3%
Other makers71%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Tacrolimus is used (Medicaid data)

A general measure of how commonly Tacrolimus is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tacrolimus is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

862,723
Medicaid prescriptions filled (Q1–Q4 2025)
$103.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tacrolimus prescribed? Of the 1,601 medications we measure, Tacrolimus ranks #192 by Medicaid prescriptions — more than 88% of them.

Where Tacrolimus ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #192 of 1,601
#187 Allopurinol 901,974 Rx #188 Ondansetron Injection 901,061 Rx #189 Budesonide Oral Inhala... 893,664 Rx #190 Latanoprost Ophthalmic 879,118 Rx #191 Ceftriaxone Injection 875,273 Rx #192 Tacrolimus 862,723 Rx #193 Cyproheptadine 854,560 Rx #194 Meclizine 846,276 Rx #195 Erythromycin Ophthalmi... 841,932 Rx #196 Lactulose 835,520 Rx #197 Haloperidol 821,226 Rx

Utilization by Tacrolimus product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.001 mg/mg topical ointment is the most-dispensed Tacrolimus product — about 29% of these Medicaid prescriptions.

tacrolimus 0.001 MG/MG Topical Ointment Most dispensed

251,501 Medicaid prescriptions (Q1–Q4 2025) 29% of Tacrolimus prescriptions shown $16.7M gross reimbursement (before rebates) ≈ $66 per prescription (gross)

Summed across the 15 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314266

tacrolimus 1 MG Oral Capsule

232,959 Medicaid prescriptions (Q1–Q4 2025) 27% of Tacrolimus prescriptions shown $15.1M gross reimbursement (before rebates) ≈ $65 per prescription (gross)

Summed across the 13 of 58 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198377

tacrolimus 0.0003 MG/MG Topical Ointment

156,984 Medicaid prescriptions (Q1–Q4 2025) 18% of Tacrolimus prescriptions shown $9.5M gross reimbursement (before rebates) ≈ $61 per prescription (gross)

Summed across the 12 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313189

tacrolimus 0.5 MG Oral Capsule

94,803 Medicaid prescriptions (Q1–Q4 2025) 11% of Tacrolimus prescriptions shown $3.1M gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 10 of 42 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313190

tacrolimus 5 MG Oral Capsule

44,205 Medicaid prescriptions (Q1–Q4 2025) 5% of Tacrolimus prescriptions shown $5M gross reimbursement (before rebates) ≈ $112 per prescription (gross)

Summed across the 10 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198378

24 HR tacrolimus 1 MG Extended Release Oral Tablet

35,192 Medicaid prescriptions (Q1–Q4 2025) 4% of Tacrolimus prescriptions shown $19M gross reimbursement (before rebates) ≈ $540 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664461

24 HR tacrolimus 4 MG Extended Release Oral Tablet

19,769 Medicaid prescriptions (Q1–Q4 2025) 2% of Tacrolimus prescriptions shown $28.6M gross reimbursement (before rebates) ≈ $1,447 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664434

BX Rating tacrolimus 1 MG Oral Capsule

8,877 Medicaid prescriptions (Q1–Q4 2025) 1% of Tacrolimus prescriptions shown $548,511 gross reimbursement (before rebates) ≈ $62 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2665162

24 HR tacrolimus 0.75 MG Extended Release Oral Tablet

8,620 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $305 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664456

BX Rating tacrolimus 0.5 MG Oral Capsule

3,012 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $65,435 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2665161

BX Rating tacrolimus 5 MG Oral Capsule

2,888 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $212,748 gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2665163

24 HR tacrolimus 1 MG Extended Release Oral Capsule

1,404 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $662,986 gross reimbursement (before rebates) ≈ $472 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431980

tacrolimus 1 MG Granules for Oral Suspension

715 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $645,444 gross reimbursement (before rebates) ≈ $903 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2052703

24 HR tacrolimus 5 MG Extended Release Oral Capsule

690 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $789,061 gross reimbursement (before rebates) ≈ $1,144 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431985

tacrolimus 0.2 MG Granules for Oral Suspension

633 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $502,655 gross reimbursement (before rebates) ≈ $794 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2052605

24 HR tacrolimus 0.5 MG Extended Release Oral Capsule

286 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $34,314 gross reimbursement (before rebates) ≈ $120 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431971

1 ML tacrolimus 5 MG/ML Injection

185 Medicaid prescriptions (Q1–Q4 2025) <1% of Tacrolimus prescriptions shown $9,217 gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198379

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tacrolimus, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 75 of 210 listed Tacrolimus NDCs with Medicaid activity.

Compare Tacrolimus products

A representative set of FDA-listed product records for Tacrolimus — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 84 of 106 products — FDA National Drug Code Directory. See every product, package size and price: browse all 106 Tacrolimus NDCs →

Tacrolimus side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tacrolimus — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Tacrolimus are drug interaction, acute kidney injury, diarrhoea; about 90% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

156,021
Reports mentioning it
90%
Reported as serious
12
Distinct effects shown
Most reported effects
Drug Interaction
6,430
Acute Kidney Injury
6,154
Diarrhoea
5,963
Death
5,065
Transplant Rejection
5,035
Pyrexia
4,888
Cytomegalovirus Infection
4,654
Pneumonia
4,576
Covid-19
3,968
Toxicity To Various Agents
3,880
Age groups
Adult · 17,536Elderly · 5,191Child · 2,326Adolescent · 1,343Neonate · 649Infant · 577

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tacrolimus in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Tacrolimus FDA approval history

How Tacrolimus went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Tacrolimus was first approved by the FDA in 1994 (Brand: PROGRAF · Astellas); the first generic version was approved in 2009. It remains available in U.S. pharmacies today.

1994
Brand approved
Brand: PROGRAF · Astellas
2009
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Tacrolimus recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Tacrolimus recalls since July 2021, covering 5 product listings. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class I Dec 23, 2024 · Astellas Pharma US Inc.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
  • Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. Lots: Lot# 0E3353D, Exp 03/31/2026 FDA record D-0211-2025 →
  • Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. Lots: Lot# 0R3092A, EXP 03/31/2026 FDA record D-0210-2025 →
Ongoing Class II Feb 8, 2023 · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
  • Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01. Lots: Lot # C2106445; Exp. 03/2024 FDA record D-0330-2023 →
Ongoing Class III Jul 11, 2022 · Glenmark Pharmaceuticals Inc., USA
Defective Container: Tube split from side seam
  • Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured… Lots: Lot #s: a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033,… FDA record D-1304-2022 →
Class II Dec 15, 2023 · Terminated · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
  • Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01 Lots: Lot# C2307275; Exp. January 2026 FDA record D-0219-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tacrolimus RxCUI 42316 6 dose forms · 17 strengths
  3. Dose form (SCDF) Granules for Oral Suspension RxCUI 2052604 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG RxCUI 2052605 1 MG RxCUI 2052703
  4. Dose form (SCDF) Injection RxCUI 1738334 In current FDA listings
    Clinical drug / strength (SCD) 1 ML tacrolimus 5 MG/ML RxCUI 198379
  6. Dose form (SCDF) Topical Ointment RxCUI 379082 In current FDA listings
    Clinical drug / strength (SCD) 0.0003 MG/MG RxCUI 313189 0.001 MG/MG RxCUI 314266

Look up RxCUI 42316 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Tacrolimus costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 1 mg $0.154 per capsule NDC details & price history
Capsule · Oral 0.5 mg $0.123 per capsule NDC details & price history
Capsule · Oral 5 mg $0.688 per capsule NDC details & price history
Ointment · Topical 1 mg/g $0.943–$0.982 per gram NDC details & price history
Ointment · Topical 0.3 mg/g $0.888–$0.998 per gram NDC details & price history
Capsule, Gelatin Coated · Oral 1 mg $7.33 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 5 mg $35.63 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 0.5 mg $3.66 per capsule NDC details & price history
Capsule, Coated, Extended Release · Oral 5 mg $27.77 per capsule NDC details & price history
Capsule, Coated, Extended Release · Oral 1 mg $5.71 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Tacrolimus brand names

Tacrolimus is sold under 5 brand names in the FDA directory — Astagraf Xl, Envarsus XR, Prograf, Astagraf and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Astagraf Xl Envarsus XR Prograf Astagraf Envarsus

Who makes Tacrolimus: manufacturers and labelers

36 companies list Tacrolimus products with the FDA. By number of product records, the largest are Astellas Pharma US, Inc., Bryant Ranch Prepack, Accord Healthcare Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Astellas Pharma US, Inc. 9 Bryant Ranch Prepack 6 Accord Healthcare Inc. 5 Glenmark Pharmaceuticals Inc., USA 5 Ajenat Pharmaceuticals LLC 3 American Health Packaging 3 Amneal Pharmaceuticals NY LLC 3 Ascend Laboratories, LLC 3 BPI Labs LLC 3 Biocon Pharma Inc. 3 Concord Biotech Limited 3 Chengdu Suncadia Medicine Co., Ltd. 3 Dr. Reddy's Laboratories Limited 3 Golden State Medical Supply, Inc. 3 Jubilant Cadista Pharmaceuticals Inc. 3 Major Pharmaceuticals 3 Mylan Pharmaceuticals Inc. 3 MylanInstitutional Inc. 3 Northstar Rx Llc 3 Panacea Biotec Limited 3 Quallent Pharmaceuticals Health LLC 3 Safecor Health LLC 3 Sandoz Inc. 3 Stellon Biotech Inc. 3

…and 12 more on the FDA NDC directory.

Tacrolimus drug class (RxNorm)

Tacrolimus belongs to the Calcineurin Inhibitor Immunosuppressant class.

Pharmacologic class Calcineurin Inhibitor Immunosuppressant
Drug family (ATC) Agents for dermatitis, excluding corticosteroids, Calcineurin inhibitors
How it works Calcineurin Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Tacrolimus page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 25, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tacrolimus.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tacrolimus after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
42
Finished products in the current FDA directory
106
Companies listing them (makers, repackagers, distributors)
36
FDA labeler codes behind them ⓘ
37
Linked representative label ⓘ
Astellas Pharma US, Inc.
Linked label effective
Aug 25, 2023
Composite sections available
24
Linked SPL Set ID
7f667de1-9dfa-4bd6-8ba0-15ee2d78873b
Linked SPL Document ID
e9157663-1515-4ba3-83b5-1622cf6f0f99
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →