FDA-filed SPL labeling · retrieved through openFDA

Tacrolimus

Tacrolimus is an immunosuppressant (anti-rejection) medication used to help prevent organ rejection after a kidney, liver, or heart transplant.

Brand names Astagraf XlEnvarsus XRPrografAstagrafEnvarsus +2 more
Drug classes ⓘ Calcineurin Inhibitor Immunosuppressant
Rx Forms 7 Routes Oral · Topical · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 →

At a glance
Linked label effectiveAug 25, 2023
Clinical labels in scope ⓘ42
AvailabilityRx
Earliest approval/marketing year ⓘ1994
FDA-listed product records ⓘ319
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026 🚨Class I recall on record · 4
Other forms & routes:
Injection Topical
⭐ Tacrolimus at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tacrolimus is a critical anti-rejection medicine that requires careful, consistent use and regular blood monitoring — skipping doses or changing how you take it can put your transplanted organ at risk. Stay alert to signs of infection or unusual skin changes and report them to your transplant team promptly. Never stop or adjust tacrolimus on your own; always work with your prescriber.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Tacrolimus carries a serious FDA boxed warning — the highest level of warning the FDA issues. Because tacrolimus suppresses your immune system, it significantly raises your risk of two life-threatening problems: serious infections (including bacterial, viral, and fungal infections that can require hospitalization) and certain cancers, especially lymphoma (a cancer of the lymph system) and skin cancers. These risks apply to tacrolimus and all other immunosuppressant medicines. Watch for fever, unusual fatigue, swollen glands, unexplained weight loss, or any new skin changes, and report them to your doctor right away.

Read the full warning on DailyMed →

📖 Tacrolimus: Patient Information Guide

A plain-language walkthrough of Tacrolimus — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Tacrolimus is used to prevent organ rejection after transplant surgery. It is approved for:

  • Kidney transplants (adults)
  • Liver transplants (adults and children)
  • Heart transplants (adults)

It is always used in combination with other immunosuppressant medicines, not on its own.

⚙️How it works▾

Tacrolimus is a calcineurin inhibitor — it works by binding to a protein inside immune cells called FKBP-12. This triggers a chain reaction that blocks an enzyme called calcineurin. Without calcineurin working properly, your T-cells (the immune cells that would attack a foreign organ) cannot activate or multiply. The result is a calmer immune system that is less likely to reject the new organ.

By blocking calcineurin, tacrolimus also reduces the production of several inflammatory signals called cytokines (chemical messengers that ramp up immune attacks). This broad dampening of immune activity is what makes it effective — but also why infection and cancer risk go up.

💊How it's taken▾

Tacrolimus capsules are generally taken twice daily, about 12 hours apart. The key rule is to take it consistently — always with food or always without food — because food can affect how much your body absorbs. Do not switch between different tacrolimus formulations (for example, immediate-release capsules versus extended-release tablets) without your doctor's guidance, as they are not interchangeable.

  • Take at the same times each day
  • Do not eat grapefruit or drink grapefruit juice
  • Your doctor will run regular blood tests to check your levels and adjust your dose
  • If you cannot swallow capsules, an oral suspension or IV form is available
🤒Side effects — in detail▾

The most commonly reported side effects include:

  • Tremor (shakiness)
  • High blood pressure
  • High blood sugar or new-onset diabetes
  • Headache
  • Diarrhea, constipation, or nausea
  • Insomnia
  • Swelling in the legs or feet
  • Infections (including CMV, urinary tract infections)

Seek immediate medical attention for signs of serious infection (fever, chills), neurological changes (confusion, vision problems, seizures), unusual skin growths, or signs of kidney trouble (decreased urination, swelling).

⚠️Warnings & precautions▾
  • Serious infections and cancer: Tacrolimus suppresses your immune system, raising the risk of life-threatening infections and lymphoma or skin cancers. This is serious enough to carry an FDA boxed warning.
  • Kidney damage (nephrotoxicity): Tacrolimus can harm the kidneys over time. Your kidney function will be monitored regularly.
  • Neurological effects: Tremor, headache, and — rarely — a serious brain condition called PRES (Posterior Reversible Encephalopathy Syndrome) can occur. Report confusion, vision changes, or seizures right away.
  • New-onset diabetes: Tacrolimus can trigger diabetes, even in people with no prior history. Blood sugar is monitored closely.
  • High potassium (hyperkalemia): Can be dangerous; potassium levels are checked regularly.
  • Medication errors: Tacrolimus immediate-release capsules are NOT the same as extended-release tacrolimus products — do not substitute one for the other.
  • Live vaccines: Avoid all live vaccines while on tacrolimus.
🔀What it interacts with▾

Tacrolimus has many important interactions because it is processed by an enzyme in the body called CYP3A. Things that affect this enzyme can raise or lower your tacrolimus levels significantly:

  • Grapefruit / grapefruit juice: Raises tacrolimus levels; avoid completely
  • Antifungal medicines (e.g., voriconazole, ketoconazole, itraconazole): Raise tacrolimus levels
  • Certain antibiotics (e.g., clarithromycin, chloramphenicol): Raise tacrolimus levels
  • HIV protease inhibitors (e.g., ritonavir, nelfinavir): Raise tacrolimus levels
  • Rifampin, phenytoin, carbamazepine, St. John's Wort: Lower tacrolimus levels, risking rejection
  • Cannabidiol (CBD): May raise tacrolimus levels; monitoring and dose adjustment needed
  • Mycophenolate (MMF): Tacrolimus raises MMF exposure; watch for added side effects
  • Sirolimus: Combination not recommended, especially in liver or heart transplant patients

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy: Do not take tacrolimus if you have had a serious allergic reaction to it before
  • Pregnancy: Tacrolimus can harm the fetus. Discuss risks and benefits with your doctor. A pregnancy registry is available (TPRI: 1-877-955-6877)
  • Kidney or liver problems: May require dose adjustments; tell your doctor about any organ impairment
  • African-American patients: May need higher doses to reach target blood levels — your transplant team accounts for this
  • Children: Approved for pediatric liver transplant patients; other pediatric uses are covered under a different brand's labeling
  • All medications and supplements: Many drugs affect tacrolimus levels — always keep your transplant team updated on everything you take
  • Sun exposure: Limit sun and UV light; use sunscreen and protective clothing to reduce skin cancer risk
🚑If you take too much▾

Overdoses of up to 30 times the intended dose have been reported, and most people had no symptoms and recovered fully. When symptoms did occur, they were similar to known side effects — tremor, high blood pressure, kidney changes, and swelling. In one case, hives and drowsiness were observed.

Tacrolimus is not effectively removed by dialysis. If an overdose is suspected, seek medical attention immediately; treatment focuses on supportive care and managing any specific symptoms.

📡Pharmacodynamics — effects in the body▾

Tacrolimus works by shutting down the activation and multiplication of T-lymphocytes — the immune cells responsible for attacking a foreign organ. It does this by blocking calcineurin, which prevents key immune signals from reaching the cell's nucleus. The result is broad suppression of the immune response, including reduced production of inflammatory cytokines (chemical messengers) like interleukins and tumor necrosis factor.

While this immune dampening protects the transplanted organ, it also reduces the body's ability to fight infections and monitor for abnormal cells — which is why cancer and infection risk are elevated during treatment.

🔬Pharmacokinetics — how your body processes it▾

When taken by mouth, tacrolimus is absorbed incompletely and variably — only about 17–23% of the dose actually reaches the bloodstream, depending on the type of transplant. Because absorption varies so much from person to person, blood level monitoring is essential to make sure each patient gets the right amount.

Tacrolimus has a relatively long half-life (the time it takes the body to clear half the drug) of roughly 32–34 hours in healthy adults, though this varies in transplant patients. The drug is extensively bound to red blood cells and proteins in the blood, which is why blood levels (rather than plasma levels) are used to guide dosing. It is not meaningfully removed by dialysis.

📦How to store it▾

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 Tacrolimus’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.

🩺 Pharmacist Counseling Corner

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.

Why do I have to take tacrolimus even when I feel completely fine? ▾
That's a great question, and it's one of the most important things to understand. Your body's immune system doesn't just stop trying to attack the new organ once you leave the hospital — it keeps recognizing it as foreign. Tacrolimus has to be in your system consistently to keep that immune response quiet. Skipping doses or stopping on your own, even when you feel well, can trigger a rejection episode that can seriously damage or destroy the transplanted organ. Think of it like a daily lock on the door — the lock has to stay on every day, not just when you think someone might try to get in.
Does it matter if I take tacrolimus with food or on an empty stomach? ▾
It actually does matter — but the key is being consistent, not choosing one over the other. Food can change how much tacrolimus your body absorbs, so if you always take it the same way (always with a meal, or always on an empty stomach), your blood levels will be more stable and predictable. What your doctor really wants to avoid is switching back and forth. Pick a routine that works for you and stick to it every day. Also, grapefruit and grapefruit juice are a hard no — they can push your tacrolimus levels dangerously high.
What side effects should I actually call my doctor about versus just wait and see? ▾
Most people notice some shakiness (tremor), headache, or stomach upset early on — those are common and worth mentioning at your next visit but not usually an emergency. However, call your doctor right away if you develop a fever, signs of infection, confusion, vision changes, or seizures — these can signal something serious. Also report new skin growths, unusual lumps, increased thirst or urination (which can mean new diabetes), or a big drop in how much you're urinating (a kidney warning sign). When in doubt, call — your transplant team would always rather hear from you.
Can I take over-the-counter medicines, vitamins, or herbal supplements while on tacrolimus? ▾
You have to be careful here. Tacrolimus is processed by a specific enzyme in your body, and many common things — including St. John's Wort (a popular herbal supplement), certain vitamins, and over-the-counter drugs — can interfere with that enzyme and push your tacrolimus levels too high or too low. Even CBD products can raise your levels enough to need a dose adjustment. Always check with your transplant pharmacist or doctor before adding anything new, even if it seems harmless.
I'm a woman of childbearing age — is it safe to get pregnant while on tacrolimus? ▾
This is something you really need to discuss carefully with your transplant team before getting pregnant. Tacrolimus can cause harm to a developing baby, including premature birth, low birth weight, and certain birth defects. At the same time, you can't simply stop taking it — rejection is a serious risk. There is a voluntary pregnancy registry (called TPRI) that helps track outcomes for transplant patients who become pregnant, and your doctor can connect you with it. If you're planning a pregnancy, your team can work with you ahead of time to minimize risks as much as possible.
Why do I need all these blood tests — can't my doctor just go by how I feel? ▾
Tacrolimus is one of those medications where the right dose is different for every person, and it's very hard to tell from symptoms alone whether your levels are in the right range. Too little tacrolimus and your organ could be rejected; too much and you're at higher risk of side effects like kidney damage, high blood pressure, or infection. The blood tests tell your doctor exactly where your levels sit so they can fine-tune your dose. It's one of the most important parts of keeping your transplant healthy long-term.
Is Tacrolimus available over the counter? ▾
Tacrolimus is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tacrolimus first available? ▾
Tacrolimus has been available in the United States since at least 1994, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tacrolimus? ▾
Tacrolimus is supplied by 72 manufacturers listed in the FDA NDC Directory, including Astellas Pharma US, Inc., Bryant Ranch Prepack, Glenmark Pharmaceuticals Inc., USA.

💬 Answers drafted from Tacrolimus’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊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

💊 How Tacrolimus 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
Available strengths 3 strengths
0.5 mg 1 mg 5 mg
218 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Protopic Tacrus
Available strengths 3 strengths
0.3 mg/g 1 mg/g 30 mg/30 g
31 FDA-listed product records ⓘ

Extended-release capsule

By mouth
Brands Astagraf Xl
Available strengths 3 strengths
0.5 mg 1 mg 5 mg
15 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Prograf
Available strengths 2 strengths
0.2 mg 1 mg
10 FDA-listed product records ⓘ

Extended-release tablet

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

Injection

Into a vein
Brands Prograf
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 across the U.S. market

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.

7
Dose forms ⓘ
72
Manufacturers
7
Brand names
319
FDA-listed product records ⓘ
1994
First marketed ⓘ

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.10%
Bryant Ranch Prepack6%
Glenmark Pharmaceuticals Inc., USA5%
Accord Healthcare Inc.5%
Major Pharmaceuticals4%
Concord Biotech Limited4%
Other makers67%

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

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 1,596 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 1,596
#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 200 of 319 products — FDA National Drug Code Directory. See every product, package size and price: browse all 319 Tacrolimus NDCs →

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.

🏷️ Sold under these brand names

Astagraf Xl Envarsus XR Prograf Astagraf Envarsus Protopic Tacrus

🏭 Manufacturers & labelers

Astellas Pharma US, Inc. 27 Bryant Ranch Prepack 16 Glenmark Pharmaceuticals Inc., USA 14 Accord Healthcare Inc. 13 Major Pharmaceuticals 10 Concord Biotech Limited 10 Mylan Pharmaceuticals Inc. 9 Strides Pharma Science Limited 9 Northstar Rx Llc 9 Veloxis Pharmaceuticals, Inc 9 Dr. Reddy's Laboratories Limited 9 Ascend Laboratories, LLC 9 Golden State Medical Supply, Inc. 9 American Health Packaging 9 Remedyrepack Inc. 8 A-S Medication Solutions 7 Panacea Biotec Limited 6 Sandoz Inc 6 Stellon Biotech Inc. 6 Biocon Pharma Inc. 6 Belcher Pharmaceuticals,LLC 6 Mylan Institutional Inc. 6 Ajenat Pharmaceuticals LLC 6 Bpi Labs Llc 5

…and 16 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 Where this comes from

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
NDC products indexed
319
Distinct labelers/manufacturers represented
72
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 42 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.