Tacrolimus is used together with other medicines in people who have had a heart, kidney, liver, or lung transplant.

Tacrolimus weakens your immune system to prevent your body from "rejecting" the transplanted organ.

Tacrolimus may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.

Using tacrolimus may increase your risk of developing serious infections or certain types of cancer, such as lymphoma or skin cancer. Your risk may be higher if you are treated over long periods of time with drugs that weaken the immune system. Ask your doctor about this risk and about symptoms to watch for.

Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most commonly in people who are Hispanic or African-American.

Tell your doctor if you have ever had:

• problems with your liver, kidney, or heart that are not related to your transplant;
• long QT syndrome (in you or a family member); or
• if you are scheduled to receive a vaccine;

Tell your doctor if you plan to get pregnant. Tacrolimus may harm an unborn baby, and can worsen conditions such as diabetes or high blood pressure in the mother. Use effective birth control before and during treatment with tacrolimus.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tacrolimus on the baby.

If you are a man, use birth control before and during treatment with tacrolimus if your sex partner is able to get pregnant.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Tacrolimus (Prograf) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, cough, sweating, painful skin sores, skin warmth or redness, or muscle aches.

Also call your doctor at once if you have:

• general ill feeling, pain or swelling near your transplanted organ;
• headaches, vision changes, pounding in your neck or ears;
• confusion, behavior changes;
• tremors, a seizure;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• chest pain, cough, trouble breathing (even while lying down);
• high blood sugar--increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, confusion;
• high potassium level--nausea, weakness, chest pain, irregular heartbeats, loss of movement;
• kidney problems--swelling, urinating less, feeling tired or short of breath;
• low magnesium or phosphate--bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes; or
• low blood cell counts--fever, flu symptoms, tiredness, pale skin, cold hands and feet.

Common side effects may include:

• low blood cell counts, infections;
• fever;
• nausea, diarrhea, constipation, stomach pain;
• weakness, pain;
• fluid around your heart;
• tremors;
• headache;
• cough, breathing problems;
• high blood sugar, high potassium levels, high cholesterol or triglycerides levels;
• low levels of magnesium or phosphate;
• numbness or tingling in your hands and feet;
• sleep problems (insomnia); or
• swelling in your hands, legs, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using tacrolimus. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Grapefruit may interact with tacrolimus and cause side effects. Avoid consuming grapefruit products.