Uses

What is topical tacrolimus used for?

Topical tacrolimus is commonly used for short-term treatment of moderate to severe atopic dermatitis, which is a type of eczema, in some people who do not have a weakened immune system. Topical tacrolimus may be used when other topical medicines for eczema cannot be used or do not work.

Topical tacrolimus may also be used for other conditions as determined by your healthcare provider.

Tacrolimus is also available in other forms that are taken by mouth or injected. See Tacrolimus for more information. 

How does topical tacrolimus work (mechanism of action)?

In eczema, you can have inflammation and irritation, possibly due to your body’s immune response to certain triggers. Topical tacrolimus works by calming down this immune response. It may do this by blocking a specific protein called calcineurin, which is involved in the immune response. By blocking the activity of calcineurin, topical tacrolimus helps to reduce inflammation and relieve itching.

How is topical tacrolimus supplied (dosage forms)?

Topical tacrolimus is available as Protopic and generic topical tacrolimus in the following dosage forms that are applied to the skin.

  • 0.03% topical ointment
  • 0.1% topical ointment

How should I store topical tacrolimus?

Topical tacrolimus should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. It should not be left in your car in cold or hot weather. The cap on the tube should be tightly closed.

Side Effects

What are the most common side effects of topical tacrolimus?

The most common side effects of topical tacrolimus are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Burning, tingling, itching, soreness, or redness where it is applied
  • Acne
  • Headache 
  • Increased sensitivity to hot or cold temperatures
  • Flu-like symptoms, including a common cold and stuffy nose
  • Viral skin infections, such as cold sores, chickenpox, or shingles
  • Upset stomach
  • Swollen glands (enlarged lymph nodes)
  • Fever
  • Swollen or infected hair follicles 
  • Sore throat 
  • Muscle pain
  • Back pain

Tell your healthcare provider if you get a skin infection or if you have a side effect that does not go away.

There may be other side effects of topical tacrolimus that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of topical tacrolimus?

While less common, the most serious side effects of topical tacrolimus are described below, along with what to do if they happen.

Severe Allergic Reactions. Topical tacrolimus may cause allergic reactions, which can be serious. Stop using tacrolimus and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use topical tacrolimus?

Allergies to Ingredients. People who are allergic to any of the following should not use topical tacrolimus.          

  • Tacrolimus
  • Protopic 
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific topical tacrolimus products they stock.

What should I know about topical tacrolimus before using it?

It is not known if it is safe to use topical tacrolimus for a long period of time. In rare cases, people who have used topical tacrolimus have reported cancer, such as skin cancer or lymphoma. But it has not been shown that topical tacrolimus causes cancer. It is best to do the following.      

  • Avoid using this medicine for a very long time without breaks
  • Only use this medicine on the affected areas of your skin and use the smallest amount needed to manage your symptoms 
  • Avoid using this medicine on a child who is younger than 2 years old

During your treatment with topical tacrolimus, it is important to remember the following. 

  • Avoid sun lamps or tanning beds and limit sun exposure, even when the medicine is not on your skin
  • If you have to be outside after applying the medicine, wear loose clothing that covers the treated area to protect it from sun
  • Avoid covering the treated skin with bandages, dressings, or wraps. You can wear your regular clothes
  • Be careful not to get topical tacrolimus in your eyes or mouth
  • To prevent your skin from getting too dry from eczema, you can use moisturizers after applying topical tacrolimus. Be sure to ask your healthcare provider first about which moisturizers you can use
  • Avoid applying this medicine to any skin areas affected by cancer

Do not use topical tacrolimus unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share topical tacrolimus with other people, even if they have the same condition as you. It may harm them.

Keep topical tacrolimus out of the reach of children.

Tell your healthcare provider if your symptoms get worse while using topical tacrolimus, or if they do not get better after using the medicine for 6 weeks.

What should I tell my healthcare provider before using topical tacrolimus?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if topical tacrolimus is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

Other Medicines and Supplements. Topical tacrolimus may interact with other medicines and supplements. Before using topical tacrolimus, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how topical tacrolimus could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. 

Breastfeeding. Tacrolimus taken by mouth passes into breast milk. While using topical tacrolimus, a small amount of the medicine may get into the body, but it is not a lot compared to taking it by mouth. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop topical tacrolimus.

Interactions

Does topical tacrolimus interact with foods or drinks?

There are no known interactions between topical tacrolimus and foods or drinks.

Drinking alcohol when using topical tacrolimus could make your face or skin turn red and feel hot.

Does topical tacrolimus interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using topical tacrolimus.

  • Ketoconazole, fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Certain antibiotics, such as clarithromycin or erythromycin
  • A calcium channel blocker, such as verapamil, diltiazem, or amlodipine, which is a medicine used to treat high blood pressure, chest pain, or other heart conditions
  • Cimetidine (Tagamet HB), which is a medicine used for heartburn
  • Any other product for use on your skin

This may not be a complete list of medicines that can interact with topical tacrolimus. Always check with your healthcare provider.

Does Tacrolimus topical (Protopic) interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much topical tacrolimus?

If you or someone else has used too much topical tacrolimus, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of topical tacrolimus?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.

Drug Survey

Are you currently using Tacrolimus topical (Protopic)?

This survey is being conducted by the WebMD marketing sciences department.