A small number of patients who used tacrolimus ointment or another similar medication developed skin cancer or lymphoma (cancer in a part of the immune system). There is not enough information available to tell whether tacrolimus ointment caused these patients to develop cancer. Studies of transplant patients and laboratory animals and an understanding of the way tacrolimus works suggest that there is a possibility that people who use tacrolimus ointment have a greater risk of developing cancer. More study is needed to understand this risk.
Use tacrolimus ointment only when you have symptoms of eczema. Stop using tacrolimus ointment when your symptoms go away or when your doctor tells you that you should stop. Do not use tacrolimus ointment continuously for a long time.
Call your doctor if you have used tacrolimus ointment for 6 weeks and your eczema symptoms have not improved, or if your symptoms get worse at any time during your treatment. A different medication may be needed.
Call your doctor if your eczema symptoms come back after your treatment with tacrolimus ointment.
Apply tacrolimus ointment only to skin that is affected by eczema. Use the smallest amount of ointment that is needed to control your symptoms.
Do not use tacrolimus ointment to treat eczema in children who are younger than 2 years old. Do not use tacrolimus ointment 0.1% to treat eczema in children who are between 2 and 15 years old. Only tacrolimus ointment 0.03% may be used to treat children in this age group.
Tell your doctor if you have or have ever had cancer, especially skin cancer, or any condition that affects your immune system. Ask your doctor if you are not sure if a condition that you have has affected your immune system. Tacrolimus may not be right for you.
Protect your skin from real and artificial sunlight during your treatment with tacrolimus ointment. Do not use sun lamps or tanning beds, and do not undergo ultraviolet light therapy. Stay out of the sunlight as much as possible during your treatment, even when the medication is not on your skin. If you need to be outside in the sun, wear loose fitting clothing to protect the treated skin, and ask your doctor about other ways to protect your skin from the sun.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tacrolimus and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using tacrolimus ointment.
Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.
Tacrolimus comes as an ointment to apply to the skin. It is usually applied twice a day to the affected area. To help you remember to apply tacrolimus ointment, apply it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use tacrolimus exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Wash your hands with soap and water.
Be sure that the skin in the affected area is dry.
Apply a thin layer of tacrolimus ointment to all affected areas of your skin.
Rub the ointment into your skin gently and completely.
Wash your hands with soap and water to remove any leftover tacrolimus ointment. Do not wash your hands if you are treating them with tacrolimus.
You may cover the treated areas with normal clothing, but do not use any bandages, dressings, or wraps.
Be careful not to wash the ointment off of affected areas of your skin. Do not swim, shower, or bathe immediately after applying tacrolimus ointment.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medicine.
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra ointment to make up for a missed dose.
skin burning, stinging, redness or soreness
tingling skin
increased sensitivity of the skin to hot or cold temperatures
itching
acne
swollen or infected hair follicles
headache
muscle or back pain
flu-like symptoms
stuffy or runny nose
nausea
swollen glands
rash
crusting, oozing, blistering or other signs of skin infection
cold sores
chicken pox or other blisters
swelling of the hands, arms, feet, ankles, or lower legs
Tacrolimus ointment may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Reviewed - 09/01/2010
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.