Tacrolimus topical ointment side effects: A detailed guide

Specifically, the Food and Drug Administration (FDA) has approved tacrolimus topical* ointment for moderate to severe atopic dermatitis. This is when other treatments haven’t worked or cannot be used. Tacrolimus topical ointment is approved for short-term use when symptoms are present.

This article describes possible side effects of tacrolimus topical ointment. You’ll also find information on cost savings and coupon options for tacrolimus.

You can explore this overview article to learn more about tacrolimus, including the drug’s uses, side effects, ways to save on cost, and more.

Tacrolimus topical ointment is a generic version of the brand-name drug Protopic. Tacrolimus also comes in injectable forms and forms that you swallow, but these forms aren’t described in this article. To learn more, talk with your doctor.

* Topical means the drug is applied to the skin.

Boxed warning: Risk of cancer with long-term use

Tacrolimus topical ointment has a boxed warning for the risk of cancer with long-term use. A boxed warning is the most serious warning from the FDA.

For details, see the “Side effects of tacrolimus in detail” section below.

More common side effects of tacrolimus

Tacrolimus topical ointment may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of tacrolimus topical ointment include:

• burning, itchy, or discolored skin after applying tacrolimus
• flu-like symptoms
• headache
• skin infection
• fever

Mild side effects of tacrolimus

Tacrolimus may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of tacrolimus topical ointment that occurred in studies include:

• burning, itchy, or discolored skin after applying tacrolimus
• skin infection
• flu-like symptoms
• headache
• fever
• cough
• runny nose
• sore throat
• asthma
• vomiting and diarrhea
• skin rash
• sinus or ear infection
• acne
• swollen lymph nodes
• swelling in the legs and feet
• depression
• hair loss
• increased blood pressure
• eye-related side effects*
• sunburn*
• mild allergic reaction*

* To learn more about this side effect, see the “Side effects of tacrolimus in detail” section below.

Tacrolimus topical ointment may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of tacrolimus

Tacrolimus may cause certain serious side effects. If you have any serious side effects from tacrolimus topical ointment, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with tacrolimus topical ointment.

Serious side effects of tacrolimus topical ointment that occurred in studies include:

• herpes simplex (a viral infection due to herpes simplex virus [HSV])
• eczema herpeticum (a rare, painful skin rash usually caused by HSV)
• pneumonia
• tooth abscess (swelling of pus in a tooth)
• risk of cancer with long-term use*
• severe allergic reaction†

* Tacrolimus topical ointment has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects of tacrolimus in detail” section below.
† To learn more about this side effect, see the “Side effects of tacrolimus in detail” section below.

Common questions about side effects of tacrolimus

Here are answers to some common questions about side effects of tacrolimus topical ointment. If you have other questions, talk with your doctor or pharmacist.

Does tacrolimus cause long-term side effects?

Yes, in some cases, tacrolimus topical ointment may cause long-term side effects. These can occur if you use the drug longer than your doctor recommends. In fact, tacrolimus topical ointment has a boxed warning about the risk of cancer with long-term use. For more details, see the “Side effects of tacrolimus in detail” section below. You can also talk with your doctor or pharmacist.

Can tacrolimus topical ointment cause kidney-related side effects?

Yes, it’s possible. Kidney-related side effects were not found in studies of tacrolimus topical ointment. But in rare cases, they were reported after the drug became available for use. They included decreased kidney function and sudden kidney failure.

Certain factors may increase the risk of having kidney-related side effects with tacrolimus treatment. This includes already having kidney problems. It may also include having skin problems that increase how much drug your body absorbs through your skin.

If you have concerns about kidney-related side effects and tacrolimus topical ointment, talk with your doctor.

Are brain-related side effects possible with tacrolimus?

Brain-related side effects are not likely with tacrolimus topical ointment. After tacrolimus became available for use, some people reported having seizures after using it. However, it’s not known if the seizures were caused by the drug or something else.

If you have concerns about seizures or brain-related side effects with tacrolimus, talk with your doctor.

Coupon for tacrolimus

Visit this page to access Optum Perks coupons and get price estimates for tacrolimus when you use the coupons. These coupons can provide significant savings on your prescription costs. 

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

Side effects of tacrolimus in detail

Below you’ll find details on some of the side effects of tacrolimus topical ointment.

Risk of cancer with long-term use

Tacrolimus has a boxed warning for the risk of cancer with long-term use. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). In studies, the risk of cancer with long-term use was rare in people using tacrolimus topical ointment. But this side effect may be serious if it occurs.

With long-term use of tacrolimus, it’s possible to develop certain types of cancers, such as lymphoma or skin cancer.

Symptoms of lymphoma may include:

• night sweats
• fever
• weight loss
• shortness of breath
• fatigue
• swollen lymph nodes

Symptoms of skin cancer may include:

• new spots or growths on the skin
• change in shape, size, or color of a spot on your skin
• skin sores that are itchy, peeling, or won’t heal
• rough, scaly, or smooth bumps on your skin

Certain factors can increase the risk of cancer with tacrolimus topical ointment. These include using tacrolimus continuously for longer than your doctor recommends. It also includes applying the drug on areas of your skin that aren’t affected by atopic dermatitis.

Ways to manage

If you have concerns about cancer with tacrolimus treatment, tell your doctor. They’ll likely recommend having regular skin checks. They’ll also likely recommend limiting exposure to the sun and wearing sunscreen.

Eye-related side effects

In studies, eye-related side effects were rare in people using tacrolimus topical ointment. This side effect was usually mild.

Eye-related side effects include dry eyes or eye pain. You may experience the following symptoms in your eyes:

• burning
• itching
• redness
• watering
• light sensitivity
• gritty feeling

Certain factors can increase the risk of eye-related side effects with tacrolimus topical ointment. These include taking certain medications or having specific medical conditions. It may also include being in dry indoor air or not blinking enough when looking at a screen.

Ways to manage

If you experience symptoms of eye-related side effects, tell your doctor. They’ll likely recommend using artificial tears or a humidifier. They may also recommend taking frequent breaks from screens.

Sunburn

In studies, sunburn was common in people using tacrolimus topical ointment. This side effect was usually mild.

With sunburn, you experience skin redness after exposure to the sun. Symptoms may include:

• skin pain
• swelling
• blisters
• skin that feels hot
• peeling skin after a few days of exposure

Certain factors can increase the risk of sunburn with tacrolimus topical ointment. These include staying in the sun for too long or being in the sun between 10 a.m. and 4 p.m. It also includes not using sunscreen.

Ways to manage

If you experience symptoms of sunburn, tell your doctor. They’ll likely recommend using a cool compress or gentle moisturizer. They may also recommend drinking more fluids and using sunscreen whenever you’re in the sun.

Allergic reaction

For some people, tacrolimus topical ointment can cause an allergic reaction. This was commonly reported in studies of the drug.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know if you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to tacrolimus topical ointment, your doctor may recommend taking a different medication instead.

Warnings for tacrolimus

Below are some factors you may want to discuss with your doctor before using tacrolimus topical ointment.

Boxed warning: Risk of cancer with long-term use

Tacrolimus topical ointment has a boxed warning for the risk of cancer with long-term use. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details, see the “Side effects of tacrolimus in detail” section above.

Other warnings

It may not be safe for you to use tacrolimus topical ointment if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether tacrolimus topical ointment is a safe treatment option for you.

Before using tacrolimus topical ointment, tell your doctor about your health and medications you take. Things to consider include:

• skin cancer and precancer
• skin conditions that make it easier to absorb topical medications
• skin infection
• swollen lymph nodes
• increased sun exposure
• immune system problems
• kidney problems
• past allergic reaction to tacrolimus

Tacrolimus and pregnancy

Tacrolimus topical ointment should not be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication. Your doctor may suggest birth control options to use during treatment with tacrolimus.

Tacrolimus and breastfeeding

Tacrolimus topical ointment should not be used while breastfeeding. This is because the drug passes into breast milk. If you’re breastfeeding or planning to do so, talk with your doctor before using this medication. Your doctor may recommend other ways to feed your child during treatment with tacrolimus.

Tacrolimus and alcohol

Tacrolimus topical ointment is known to interact with alcohol. Drinking alcohol while using tacrolimus ointment can cause your skin to become discolored, flushed (temporarily warm or deepened in color), and hot. This may make atopic dermatitis feel worse.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with tacrolimus topical ointment.

What to ask your doctor

This article describes common and serious side effects of tacrolimus topical ointment. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

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

• Do I have an increased risk of side effects than others?
• Is my risk of burning and itching skin higher when I first start using tacrolimus topical ointment?
• Does my risk for side effects increase the longer I use tacrolimus topical ointment?

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.