Medications and Drugs

Brand Names: Prograf

Generic Name: tacrolimus (oral) (Pronunciation: ta KROE li mus)

What is tacrolimus (Prograf)?

Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

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

Prograf 0.5 mg

yellow, imprinted with 0.5mg, LOGO 607

Prograf 1 mg

white, imprinted with 1 mg, 617

Prograf 5 mg

peach, imprinted with 5mg, LOGO 657

What are the possible side effects of tacrolimus (Prograf)?

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

Call your doctor at once if you have a serious side effect such as:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
pain in the lower back or side, blood in your urine, pain or burning when you urinate;
urinating less than usual or not at all;
dry cough, cough with mucus or blood, sweating, pale skin, shortness of breath, wheezing, gasping for breath, chest pain;
tremors (shaking), confusion, changes in your mental state, vision changes, seizure (convulsions);
high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
low magnesium (jerky muscle movements, muscle weakness or limp feeling, slow reflexes);
high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats); or
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

nausea, stomach pain, diarrhea, constipation;
headache, weakness;
sleep problems (insomnia); or
swelling in your hands 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.

What is the most important information I should know about tacrolimus (Prograf)?

Treatment with tacrolimus may increase your risk of developing certain life-threatening conditions, including serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication.

You will need regular medical tests to be sure this medication is not causing harmful effects. Do not miss any follow up visits to your doctor for blood or urine tests. Avoid being near people who are sick or have infections.

Tacrolimus can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using tacrolimus, tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Some people receiving tacrolimus after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.

What should I discuss with my healthcare provider before taking tacrolimus (Prograf)?»

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.