Tacrolimus

Medically reviewed by Elizabeth Scheffel, PharmD on May 30, 2023
Written by Helen Marshall, BPharm, MRPharmS

This article describes tacrolimus’s uses, side effects, and more. Below you’ll also find some coupon options to help save on the cost of tacrolimus.

Boxed warnings

Tacrolimus has boxed warnings about the following risks. Boxed warnings are serious warnings from the Food and Drug Administration (FDA).

• serious infection with tacrolimus oral capsule
• cancer with tacrolimus topical ointment (long-term use) and oral capsule

For details, see the “Interactions and warnings for tacrolimus” section below.

Tacrolimus may cause mild or serious side effects (also known as adverse effects). More common mild side effects of tacrolimus and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about tacrolimus’s side effects, ask your doctor or pharmacist. You can also read the prescribing information* for tacrolimus.

* To view tacrolimus’s prescribing information, see the “Article resources” section below.

Mild side effects

More common mild side effects reported with some forms of tacrolimus are listed below. These side effects may differ based on the form of tacrolimus you use.

This article doesn’t include all possible mild side effects of the drug. To learn more about tacrolimus’s side effects based on the form, see the prescribing information* for tacrolimus.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Tacrolimus topical ointment’s mild side effects include:

• a sensation of burning, stinging, or itching in the area you apply the ointment
• headache
• flu-like symptoms
• skin infection
• mild allergic reaction†

Tacrolimus oral capsule’s mild side effects include:

• tremor
• headache
• digestive problems, such as diarrhea, constipation, or nausea
• trouble sleeping
• mild allergic reaction†

* To view tacrolimus’s prescribing information, see the “Article resources” section below.
† For details about this side effect, see the “Interactions and warnings for tacrolimus” section below.

Serious side effects

Serious side effects of tacrolimus are listed below. These side effects may differ based on the form of tacrolimus you use.

This article doesn’t include all possible serious side effects of the drug. To learn more about tacrolimus’s side effects based on the form, see the prescribing information* for tacrolimus.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, tacrolimus’s serious side effects include:

• kidney problems
• boxed warnings: risks of serious infection and cancer†
• severe allergic reaction†

* To view tacrolimus’s prescribing information, see the “Article resources” section below.
† For details about this side effect, see the “Interactions and warnings for tacrolimus” section below.

Below you’ll find answers to a few commonly asked questions about tacrolimus.

Can tacrolimus be used for vitiligo, eczema, or psoriasis?

Yes, topical forms of tacrolimus may be used for these conditions. Tacrolimus topical ointment is only approved to treat atopic dermatitis, which is a form of eczema. But it may also be used off-label for other forms of eczema. With off-label use, a drug is prescribed for a use that’s not approved by the Food and Drug Administration (FDA).

Tacrolimus topical ointment may also be prescribed off-label to treat psoriasis and vitiligo. To learn more about using tacrolimus off-label for these conditions, talk with your doctor.

Is tacrolimus similar to pimecrolimus or sirolimus?

Yes, tacrolimus is similar to pimecrolimus and sirolimus. All of these drugs are immunosuppressants. They reduce activity in a part of your immune system (your body’s defense system). Tacrolimus and pimecrolimus work in the same way, but sirolimus works differently from the other two drugs. And there are some other differences between these drugs.

Tacrolimus comes as a topical ointment and an oral capsule. The ointment is used for moderate to severe atopic dermatitis. It’s similar to pimecrolimus (Elidel), which comes as a topical cream. These medications are prescribed for the same use and have similar side effects. But some research has found that tacrolimus may be more effective for atopic dermatitis than pimecrolimus.

Tacrolimus oral capsule is used to help prevent rejection of liver, kidney, and heart transplants. It’s similar to sirolimus (Rapamune), which comes as a tablet and oral solution. However, sirolimus is only used to help prevent rejection of kidney transplants.

To learn more about how tacrolimus compares with other treatments for your condition, talk with your doctor.

What are the available brand names for tacrolimus?

The brand-name version of tacrolimus oral capsule is called Prograf. Other available brand-name forms of oral tacrolimus include Astagraf XL and Envarsus XR. These are extended-release forms of the drug. They’re not available as generic versions.

The brand-name version of tacrolimus topical ointment is called Protopic.

If you’re interested in using a brand-name form of tacrolimus, talk with your doctor.

Does tacrolimus cause long-term side effects?

Yes, in some cases, tacrolimus may cause long-term side effects. These can occur if you use the drug for a long time or may last for a while after you’ve stopped using the drug. These side effects may differ based on the form of tacrolimus you use.

Examples of long-term side effects include:

• kidney problems
• serious infections*
• cancers*

Talk with your doctor to learn more about these side effects and how long they may last.

* Tacrolimus has a boxed warning for this side effect. For details, see the “Interactions and warnings for tacrolimus” section below.

Is tacrolimus a steroid?

No, tacrolimus is not a steroid. Instead, it’s a type of drug called an immunosuppressant.

Steroids (also called corticosteroids) may be prescribed for the same uses as tacrolimus. But they work in a different way than tacrolimus and can cause different side effects.

To learn more about how tacrolimus compares with steroids, talk with your doctor.

How does tacrolimus work? And how long does it take to start working?

Tacrolimus works by reducing activity in a part of your immune system (your body’s defense system).

When applied to the skin, tacrolimus reduces the immune responses in your skin that cause atopic dermatitis. This decreases skin inflammation (swelling and redness or discoloration) and itching. Tacrolimus usually starts working as soon as you start using it on your skin. But it may take 1–3 weeks for your symptoms to get better.

When taken by mouth, tacrolimus reduces immune responses that could cause your body to attack a transplanted organ. It starts working to prevent your body rejecting a transplanted organ as soon as you start taking it.

The dosage of tacrolimus your doctor prescribes may vary based on your condition and certain other factors. Talk with your doctor about the dosage you should use.

Taking or applying tacrolimus

Tacrolimus oral capsule is taken by mouth. It can be taken with or without food. If you take it with food, you should try to always take it with food, and vice versa.

Tacrolimus topical ointment is applied thinly to affected areas of skin only.

Your doctor will talk with you about how to take or apply tacrolimus. They’ll explain how much to take or apply and how often. Always follow your doctor’s recommendation.

Overdose of tacrolimus

You should not use more tacrolimus than your doctor prescribes. For some drugs, doing so may lead to serious side effects or overdose.

If you think you’ve used too much tacrolimus, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

The Food and Drug Administration (FDA) approves prescription drugs such as tacrolimus for certain conditions. Approved uses for tacrolimus are described below. These uses differ based on the form of tacrolimus prescribed.

Use for atopic dermatitis

Doctors may prescribe tacrolimus topical ointment for treating moderate to severe atopic dermatitis, which is a form of eczema. It’s used when other treatments haven’t worked or aren’t suitable. For this purpose, it’s prescribed to adults and children ages 2 years and older. It’s usually prescribed as a short-term treatment.

With atopic dermatitis, your skin reacts excessively to things that are usually harmless. This causes patches of skin inflammation (swelling and redness or discoloration), itching, and dryness. At times, these symptoms may become worse (flare up) and then ease or go away.

Tacrolimus is used to treat flare-ups of atopic dermatitis. It reduces the immune responses in your skin that cause your symptoms. It also helps ease skin inflammation, itching, and dryness.

Doctors may not prescribe tacrolimus topical ointment in certain situations, such as if you have a weakened immune system.

Use for prevention of organ rejection

Doctors may prescribe tacrolimus oral capsule to help prevent rejection of certain organ transplants. It’s used for this purpose in adults who’ve received a kidney, heart, or liver transplant, and in children who’ve received a liver transplant. It’s usually prescribed as a long-term treatment.

When you receive an organ transplant, your immune system (your body’s defense system) may attack the newly transplanted organ. This is called rejection. It can damage the transplanted organ and cause it to fail.

Tacrolimus reduces activity in your immune system. This decreases the immune responses that attack the transplanted organ, which helps prevent rejection.

Tacrolimus is prescribed together with other immunosuppressant drugs to help prevent transplant rejection.

Below, you’ll find information about tacrolimus’s possible interactions and warnings.

Interactions of tacrolimus

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take or use tacrolimus, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription medications
• over-the-counter medications
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for tacrolimus” section below.

Warnings for tacrolimus

Some people should not use tacrolimus, and others should use it cautiously.

Boxed warnings

Tacrolimus has boxed warnings about risks of serious infection and cancer. Boxed warnings are serious warnings from the Food and Drug Administration (FDA).

To learn more about these warnings, read below. You can also talk with your doctor or pharmacist.

Risk of serious infection. Tacrolimus oral capsule weakens your immune system (your body’s defense system). It can raise your risk of serious infections that may need treatment in a hospital and could be fatal. Serious infections were commonly reported in studies of tacrolimus oral capsule.

Symptoms may include fever, chills, sweats, cough, muscle aches, and warm, painful areas on your skin.

If you experience any symptoms of infection, tell your doctor right away. They’ll likely prescribe medication to treat the infection.

Risk of cancer. Rare cases of certain cancers have been reported in people using tacrolimus ointment long term and in people taking tacrolimus oral capsules. Examples include lymphoma (a type of blood cancer) and skin cancer. It’s not known for sure whether these cancers were caused by the medication.

As a precaution, you should not use tacrolimus topical ointment for long periods of time without having breaks from treatment. Be sure to apply the ointment only to skin affected by atopic dermatitis. The ointment should not be used by children younger than 2 years old. And only the lower strength of ointment (0.03%) should be used by children ages 2–15 years.

To help reduce your risk for skin cancer, you should limit the amount of time you spend in the sun during tacrolimus treatment. When you are outside in the daytime, use sunscreen and wear clothing that protects your skin from sunlight. You should also avoid using tanning beds.

If you have concerns about the possible risk of cancer with tacrolimus, talk with your doctor.

Other warnings

Tacrolimus could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether tacrolimus is a safe option for you. These warnings may differ based on the form of tacrolimus you use.

Ask your doctor about specific warnings for tacrolimus, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Tacrolimus can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to tacrolimus or any of its ingredients, your doctor will likely not prescribe tacrolimus. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to tacrolimus, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Pregnancy or breastfeeding and tacrolimus

Information about tacrolimus and pregnancy and breastfeeding is described below.

Tacrolimus and pregnancy

It’s not known whether tacrolimus should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

Tacrolimus and breastfeeding

It’s not known whether tacrolimus should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication.

You may be able to save money on your prescription for tacrolimus by using our Perks discount coupons. They can be found at the end of this article.

If you have questions about how to pay for tacrolimus, talk with your doctor or pharmacist.

Note: Optum Perks coupons cannot be used with insurance copays or benefits.

This article describes the uses and side effects of tacrolimus, ways to save on its cost, and more. Let your doctor know if you have questions about tacrolimus or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Can tacrolimus cause hair loss or skin-related side effects?
• Do I need to avoid anything while using tacrolimus?
• What other treatment options are available for my condition?
• If I have side effects, how will these be treated?

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Martins JC, et al. (2015). Topical tacrolimus for atopic dermatitis. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009864.pub2/full
• Tacrolimus capsules, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a2e55495-10cc-4f6e-b866-1e7d6e45888b/spl-doc
• Tacrolimus ointment 0.03%; tacrolimus ointment 0.1%. (2021). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/de81b7df-a4d6-431f-8ec4-06755a417da8/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.