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Prograf is the brand name for tacrolimus and is available as an oral capsule and oral suspension.

Prograf is available as 0.5 mg, 1 mg, and 5 mg oral capsule and 0.2 mg and 1 mg granules for oral suspension,

Prograf is a calcineurin inhibitor that is used for the prevention of organ transplant rejection, including:

• Kidney transplant
• Liver or heart transplant – generic tacrolimus capsule and brand Prograf only
• Lung transplant – brand Prograf only

Prograf is a calcineurin inhibitor. It works as an immunosuppressant, which lowers the activity of your immune system. You need a weakened immune system after receiving an organ transplant so your body doesn’t reject the new organ.

Your provider will determine your dose of Prograf based on your weight, ethnicity, kidney or liver health, the type of transplant you received, and the other immunosuppressants you’re taking. It is typically taken by mouth twice daily.

Prograf is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have a hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated
castor oil).

Common side effects of Prograf:

• Tremor
• High blood pressure
• Changes in electrolyte levels
• Infections
• Higher creatinine levels
• Headache
• Diarrhea
• Nause
• Swelling of hands and feet
• Constipation
• Feeling weak
• General pain
• Trouble sleeping
• Low red blood cell count

Serious side effects are rare with Prograf. Contact your healthcare provider immediately if you experience any of the following.

• Abnormal heart rhythm (QT prolongation): chest pounding, trouble breathing, chest pain, feeling faint or lightheaded
• Serious infections: fever, cough, chills, sore throat, runny or stuffy nose, body aches
• Low blood cell counts: bleeding that’s difficult to stop, vomiting blood, blood in the urine or stool, “coffee-ground” stool
• Heart attack: chest pain, stomach discomfort, sweating, nausea, dizziness
• Stroke: sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, difficulty walking
• Sudden kidney injury: feeling sick or weak, dehydration, urinating less than usual, confusion, blood in urine, swelling in the legs, ankles, or feet
• Nerve problems: seizures, tremors, headache, dizziness, pins sensation

The following medications may interact with Prograf:

• Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to Prograf; monitor for MPA-related
• adverse reactions and adjust MMF or MPA dose as needed
• Nelfinavir and Grapefruit Juice: Increased tacrolimus concentrations via CYP3A inhibition; avoid concomitant use
• CYP3A Inhibitors: Increased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed
• CYP3A4 Inducers: Decreased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed
• Therapeutic drug monitoring and dose reduction for Prograf should be considered when Prograf is co-administered with cannabidiol

Astellas Pharma US, Inc.

Prograf can cause fetal harm when administered to a pregnant woman. There is a pregnancy registry that monitors pregnancy outcomes in women exposed to Prograf during pregnancy. The Transplantation Pregnancy Registry International (TPRI) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including Prograf. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or
Transplant pregnancy registry 

• Tacrolimus