Prescription medication · Calcineurin Inhibitor (Topical)

tacrolimus topical

Also sold as Protopic. This medicine is used to prevent your body from rejecting a new kidney after a transplant.

Data updated 2026-05-15

25
InteractionsSeveral interactions
$0.80
Generic price (NADAC)

tacrolimus topical (Protopic) is a prescription Calcineurin Inhibitor (Topical). This medicine is used to prevent your body from rejecting a new kidney after a transplant.

Tacrolimus extended-release capsules help prevent organ rejection in kidney transplant patients. It works by suppressing your immune system.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Generic Price

$0.80/unit

Generic Available

Yes (18 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

NADAC price trail: TACROLIMUS 0.03% OINTMENT

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +16.9% vs prior release.

Effective NADAC / unit vs prior NDCs
July 17, 2024 $0.7269/GM - 3
December 18, 2024 $0.8494/GM +16.9% 12
View Alternatives → Compare with Another Drug →

What it does

This medicine is used to prevent your body from rejecting a new kidney after a transplant.

Common side effects

Diarrhea, Constipation, Nausea

Key warnings

This medicine can increase your risk of serious infections and certain cancers.

The sections below are summarized in plain English from tacrolimus topical's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Tacrolimus belongs to a class of drugs called calcineurin inhibitors. It lowers the activity of your immune system. This helps prevent your body from attacking your new kidney.

Serious Warnings

This medicine can increase your risk of serious infections and certain cancers. These problems could lead to hospitalization or even death. This drug is not approved for liver transplants and may increase the risk of death in female liver transplant patients.

Known Drug Interactions

moderate omeprazole

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (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 ( 5.7 , 5.10 , 5.11 )] .

Mechanism: Omeprazole slows down the process your body uses to remove tacrolimus, which can cause the drug to reach risky levels in your blood.

moderate estradiol

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (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 ( 5.7 , 5.10 , 5.11 )] .

Mechanism: Estradiol can slow down how your body breaks down tacrolimus, which may increase the amount of medicine in your blood to unsafe levels.

moderate diltiazem

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (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 ( 5.7 , 5.10 , 5.11 )] .

Mechanism: Diltiazem interferes with the way your body processes tacrolimus, which can cause the drug to build up and increase the risk of heart or nerve problems.

moderate nifedipine

Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (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 ( 5.7 , 5.10 , 5.11 )] .

Mechanism: Nifedipine slows down how your body breaks down tacrolimus, which can cause the drug to build up to unsafe levels in your blood.

moderate ketoconazole

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).

Mechanism: Ketoconazole is a strong blocker of the enzyme that clears tacrolimus from your body, leading to much higher levels of the drug in your system.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I switch between different types of tacrolimus?
No, you should not switch between tacrolimus extended-release capsules, extended-release tablets, immediate-release capsules, or oral suspension without your doctor's supervision.
What should I do if I can't swallow the capsules whole?
You must swallow the capsules whole. Do not chew, divide, or crush them.
Will I need blood tests while taking this medicine?
Yes, your doctor will regularly monitor the level of tacrolimus in your blood to make sure you are getting the right dose.
Can this medicine cause diabetes?
Yes, tacrolimus can cause new-onset diabetes after transplant. Your doctor will monitor your blood sugar levels.
What if I develop nerve problems?
Tell your doctor right away if you experience any neurological problems, such as headaches, seizures, confusion, or vision changes.
Does this medicine affect my potassium levels?
Yes, tacrolimus can increase your potassium levels. Your doctor will monitor your potassium levels, especially if you take other medicines that can also increase potassium.
Can tacrolimus affect my blood pressure?
Yes, tacrolimus can raise your blood pressure. Your doctor will monitor your blood pressure and may prescribe medicine to lower it.
Should I get vaccinated while taking tacrolimus?
Avoid live vaccines while taking tacrolimus. Talk to your doctor about which vaccines are safe for you.
What are the symptoms of an infection?
Signs of infection include fever, chills, sore throat, cough, body aches, and fatigue. Tell your doctor right away if you think you have an infection.
Can I be in the sun?
Limit sun exposure. Wear protective clothing and sunscreen.
What are the common side effects of tacrolimus topical?
The registry lists Diarrhea, Constipation, Nausea, Swelling in your arms and legs, Tremors among the most-reported FAERS reaction terms for tacrolimus topical. These counts are not an individual symptom assessment.
Does tacrolimus topical interact with other medications?
The registry has 25 documented interaction rows for tacrolimus topical. Notable source-record pairings include omeprazole, estradiol, diltiazem. These rows are not a complete medication review.
What drug class is tacrolimus topical?
tacrolimus topical belongs to the Calcineurin Inhibitor (Topical) drug class. It requires a prescription (Rx). This medicine is used to prevent your body from rejecting a new kidney after a transplant.
What pregnancy or breastfeeding source fields are listed for tacrolimus topical?
The FDA label for tacrolimus topical contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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Medication Guides

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What the FDA Data Shows for tacrolimus topical

The FDA label for tacrolimus topical (sold under brand names such as Protopic) classifies it as a prescription-only medication in the Calcineurin Inhibitor (Topical) class. This medicine is used to prevent your body from rejecting a new kidney after a transplant. Official labeling lists 6 commonly reported side effects, including Diarrhea, Constipation, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 25 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.80.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: February 7, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page