tacrolimus topical
Brand names: Protopic
Tacrolimus extended-release capsules help prevent organ rejection in kidney transplant patients. It works by suppressing your immune system.
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 →
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.
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.
How to Take It
Take the capsules whole, without chewing, crushing, or dividing them. Take it every morning at the same time on an empty stomach. This means at least 1 hour before eating or 2 hours after eating. Avoid grapefruit, grapefruit juice, and alcohol while taking this medicine.
Pregnancy & Breastfeeding
Tacrolimus can harm your unborn baby. Tell your doctor right away if you are pregnant or plan to become pregnant. There is a pregnancy registry to track outcomes in women who take tacrolimus during pregnancy.
Missed Dose
If you miss a dose, take it as soon as you remember, as long as it's within 14 hours of your scheduled time. If it's been longer than 14 hours, skip the missed dose and take your next dose at the usual time. Do not double your next dose.
Storage
Store the capsules at room temperature (between 59°F and 86°F).
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
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.
What to do: Your doctor should monitor your blood levels closely to watch for signs of serious side effects like nerve or heart issues.
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.
What to do: Your healthcare provider should check your blood levels and watch for any signs of toxicity while you are using both medications.
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.
What to do: Your doctor may need to adjust your dosage and monitor your blood levels frequently to ensure your safety.
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.
What to do: Your doctor may need to monitor your blood levels closely and adjust your dose to prevent serious side effects.
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.
What to do: Use this combination with caution as your doctor may need to lower your tacrolimus dose and watch for signs of toxicity.
Common Questions
Can I switch between different types of tacrolimus?
What should I do if I can't swallow the capsules whole?
Will I need blood tests while taking this medicine?
Can this medicine cause diabetes?
What if I develop nerve problems?
Does this medicine affect my potassium levels?
Can tacrolimus affect my blood pressure?
Should I get vaccinated while taking tacrolimus?
What are the symptoms of an infection?
Can I be in the sun?
What are the common side effects of tacrolimus topical?
Does tacrolimus topical interact with other medications?
What drug class is tacrolimus topical?
Is tacrolimus topical safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: February 7, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages