Tacrolimus

Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. Headache, acne, small red bumps on the skin (folliculitis), stomach upset, flu-like symptoms (such as fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, back/joint/muscle pain, appearance of any skin infections or sores (such as chicken pox, shingles, lip sores, tumors, warts), chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for a certain skin condition that causes patchy loss of skin coloring (vitiligo).

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (such as sirolimus); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: use of light therapy (such as UVA or UVB), cancer (such as skin cancer), other skin conditions (such as Netherton's syndrome, skin infections including herpes, shingles), kidney disease, immune system problems (such as HIV).

This drug may make you more sensitive to the effects of alcohol. Your face or skin may flush red and feel hot. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor tells you to.

Talk with your doctor about other ways to manage your eczema, such as using moisturizers and taking shorter baths/showers.

The long-term safety of this drug is not known. There have been rare reports of cancer (such as skin cancer, lymphoma) in patients using tacrolimus on the skin. It is unknown if tacrolimus caused these cancers. Because of this possible risk, this drug should be used only if other drugs have not worked or if your doctor decides that other medications should not be used for your condition. Tacrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. This medication should not be used by children younger than 2 years. Discuss the risks, benefits, and proper use of this medication with your doctor. Tell your doctor right away if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, or swollen lymph nodes.