Tacrolimus (Systemic)

Pediatric Medication

Brand Names: US

Astagraf XL; Envarsus XR; Hecoria [DSC]; Prograf

Brand Names: Canada

Advagraf; Prograf; Sandoz-Tacrolimus


All products:

  • This drug may raise the chance of getting cancer like lymphoma or skin cancer. Talk with the doctor.
  • This drug may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.

Long-acting capsules:

  • In one study of patients who used this drug after a liver transplant, a larger number of deaths happened in women. This drug is not for use after a liver transplant.

What is this drug used for?

  • It is used to keep the body from harming the organ after an organ transplant.
  • It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has a long QT on ECG.
  • If your child is taking any of these drugs: Cyclosporine or sirolimus.

If your child is breast-feeding a baby:

  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

All products:

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Many other drugs affect how much of this drug is in your child’s body. This may raise the chance of organ rejection or raise the chance of side effects. If your child takes other drugs, check with the doctor to see if your child needs to have blood work checked more closely while taking them with this drug.
  • High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
  • This drug may raise the chance of high blood sugar (diabetes). The chance may be raised in people who are black or Hispanic. Talk with the doctor.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • Avoid giving your child grapefruit and grapefruit juice.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is taking a salt substitute that has potassium, potassium-saving water pills, or extra potassium, talk with the doctor.
  • Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • There is a chance of skin cancer. Have your child avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects your child from the sun.
  • Very bad and sometimes deadly holes in the GI (gastrointestinal) tract have happened with this drug. Talk with the doctor.
  • A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this drug. Talk with the doctor.
  • This drug may cause a type of abnormal heartbeat (prolonged QT interval). If this happens, the chance of other unsafe and sometimes deadly abnormal heartbeats may be raised. Talk with the doctor.

If your child is pregnant:

  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.

All oral products:

  • Check your child’s drug when you get a new prescription to make sure you have the right drug. Call the doctor right away if you think you were given the wrong drug or if you are not sure what your child’s drug should look like.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A heartbeat that does not feel normal.
  • Chest pain or pressure.
  • Shortness of breath.
  • Very bad dizziness or passing out.
  • Seizures.
  • Feeling confused.
  • Feeling less alert.
  • Change in eyesight.
  • Loss of eyesight.
  • Shakiness.
  • Trouble moving around.
  • Any unexplained bruising or bleeding.
  • Swelling in the arms or legs.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color or size of a mole.
  • A skin lump or growth.
  • Any skin change.
  • Swollen gland.
  • Night sweats.
  • Weight gain or loss.
  • Pale skin.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell the doctor right away if your child has signs like confusion, memory problems, low mood (depression), change in the way your child acts, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Not hungry.
  • Not able to sleep.
  • Back pain.
  • Joint pain.
  • Nose or throat irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All oral products:

  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • To gain the most benefit, do not miss giving your child doses.
  • Give this drug at the same time of day.

Short-acting capsule:

  • Give this drug with or without food. Always give with food or always give on an empty stomach.

All long-acting products:

  • Give in the morning on an empty stomach. Give at least 1 hour before or at least 2 hours after breakfast.
  • Have your child swallow whole with a drink of water.
  • Do not let your child chew, break, or crush.
  • If your child has trouble swallowing, talk with the doctor.


  • It is given as an infusion into a vein over a period of time.

What do I do if my child misses a dose?

Short-acting capsule:

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.

Long-acting capsules:

  • Give a missed dose as soon as you think about it.
  • If it has been 14 hours or more since the missed dose, skip the missed dose and go back to your child’s normal time.

Extended-release tablets:

  • Give a missed dose as soon as you think about it.
  • If it has been more than 15 hours since the missed dose, skip the missed dose and go back to your child’s normal time.

All oral products:

  • Do not give 2 doses at the same time or extra doses.


  • Call your doctor to find out what to do.

How do I store and/or throw out this drug?

All oral products:

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.


  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.

All products:

  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date



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