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Important Safety Information About Prograf^® (tacrolimus capsules)

Prograf^® (tacrolimus capsules) is approved for the prevention of organ rejection in patients who have received a liver, kidney, or heart transplant. Only physicians and facilities specializing in transplantation should manage patients taking Prograf. Anti-rejection medications may increase the possibility of developing an infection or lymphoma, a type of cancer.

Before starting Prograf, tell your doctor if you are pregnant, planning to have a baby, or breastfeeding. Since some medicines can affect your body's ability to use Prograf, tell your doctor whenever you receive a new medicine, including any over-the-counter medicines or herbal supplements. Do not eat grapefruit or drink grapefruit juice in combination with Prograf.

In clinical studies, up to 22% of patients taking Prograf developed insulin dependent diabetes, but in some patients, after 2 years, insulin was no longer required. Black and Hispanic kidney transplant patients were at an increased risk. Early signs of diabetes include frequent thirst or urination, blurred vision, or confusion. You should tell your doctor if you experience any of these.

Prograf has been associated with toxicity to the kidneys and nervous system. Common side effects are tremor, headache, high blood pressure, diarrhea, nausea, constipation, stomach pain, changes in kidney function, diabetes, low white cell count, infection, and high cholesterol/lipid levels.

Prograf should not be used in patients allergic to tacrolimus. Take Prograf exactly as your doctor tells you to. Take it before or after you eat at the same time each day. Only your healthcare professional can weigh the risks and benefits of a prescription medication and decide which medication is the right one for you.

Please see the full prescribing information.