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Overview: Everolimus is used to prevent organ rejection after a transplant. It works by suppressing the immune system. The most common side effects are nausea, fluid retention, high blood pressure, and diarrhea or constipation. Serious side effects may include severe infections, blood clots, lung inflammation, kidney damage, and an increased risk of cancer. Everolimus comes as a tablet that you take by mouth.

Uses

What is everolimus used for?

Everolimus is commonly used to prevent organ rejection after a kidney transplant or liver transplant. Organ rejection can happen if your immune system sees the new organ as something that does not belong in your body and attacks it.

Everolimus may also be used for other conditions as determined by your health care provider.

Everolimus is also available in a form that is used for certain types of cancers, tumors, or other conditions. See everolimus (Afinitor) for more information.

How does everolimus work (mechanism of action)?

After an organ transplant, everolimus prevents organ rejection by suppressing the immune system. Everolimus is an mTOR inhibitor. mTOR is a protein that controls the growth and activity of certain cells in the immune system. Everolimus blocks mTOR, which prevents these cells from attacking the transplanted organ. 

How is everolimus supplied (dosage forms)?

Brands and other names

  • Zortress

Dosage forms and strengths

  • 0.25 mg oral tablets
  • 0.5 mg oral tablets
  • 0.75 mg oral tablets
  • 1 mg oral tablets

How should I store everolimus?

Everolimus should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you're transporting it. Store it in a cool, dry place that is protected from light.

Side Effects

What are the most common side effects of everolimus?

The most common side effects of everolimus are listed below. These side effects may vary based on why you are taking everolimus. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of everolimus that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of everolimus?

While less common, the most serious side effects of everolimus are described below, along with what to do if they happen.

Severe Allergic Reactions. Everolimus may cause allergic reactions, which can be serious. Stop taking everolimus and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Angioedema. Everolimus may cause a rare reaction called angioedema. The usual symptoms of this reaction include swelling of the lips, face, tongue, or throat. The risk of angioedema may be higher if you are taking certain other medicines. Stop taking this medicine and contact your health care provider if you have this type of swelling. If you are having trouble breathing, get medical attention right away.

Infections. Everolimus can weaken your immune system and increase your risk of infections, including serious infections that can lead to death. It may also increase the risk of a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML) or an infection called BK viral nephritis. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever, sweats, chills, or muscle aches
  • Sore throat or feeling more tired than usual
  • Coughing, especially coughing up blood
  • Burning or stinging when you pee or blood in your pee
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Clumsiness or loss of coordination
  • Trouble walking, speaking, or thinking clearly
  • Facial drooping or vision problems
  • Weakness on one side of your body that gets worse
  • Seizures

Cancer. Everolimus can cause a new cancer to develop, including blood or skin cancer, or cause a previously treated cancer to come back. Try to avoid or limit being in light from the sun, sunlamps, and tanning beds while using everolimus. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin. Tell your health care provider about any new symptoms or skin changes.

Fluid Retention (Edema). Everolimus can cause fluid retention, also called edema. Fluid may build up around your heart or lungs, or cause swelling in different areas of your body. Call your health care provider right away if you have any of the following symptoms of fluid retention.

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath
  • Stretched or shiny skin
  • Swelling in your legs, ankles, feet, belly, or other body parts

High Cholesterol Levels (Hyperlipidemia). Everolimus can increase the levels of fats in your blood, which may cause high cholesterol or triglycerides. This does not usually cause symptoms, but it can lead to serious health problems if left untreated. Keep all appointments to have your blood checked while taking everolimus. Follow any advice given by your health care provider about exercise, dietary changes, or medicine that may be needed to lower the levels of fats in your blood. 

Kidney Damage. Kidney damage can happen when taking everolimus. Your risk may be higher if you take everolimus for a long time with certain medicines. Everolimus may also increase the risk of protein in the urine (pee), also known as proteinuria. Keep all appointments to have your kidneys checked, which may include blood and urine tests. Call your health care provider right away if you have any of the following symptoms of kidney damage.

  • Peeing less or more than usual
  • Foamy or bubbly pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Trouble catching your breath or chest pain/pressure
  • Confusion
  • Nausea or loss of appetite

Lung Inflammation. Everolimus can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Blood Clots. Everolimus may raise the risk of clots in blood vessels in the kidney or liver, especially within the first month after a kidney or liver transplant. Everolimus can also cause thrombotic microangiopathy, which is when blood clots form in small blood vessels. Your risk may be higher if you take another medicine called cyclosporine while taking everolimus. Keep all appointments to have your blood checked. Tell your health care provider right away if you have any of the following symptoms.

  • Peeing less than usual or not at all
  • Pain in your lower back, side, stomach, or groin
  • Dark or bloody urine
  • Fever
  • Nausea or vomiting
  • Bruising or red dots under your skin
  • Confusion
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Diabetes. Everolimus can increase blood sugar levels, which may lead to or worsen diabetes. Keep all appointments with your health care provider to have your blood checked. Call your health care provider if you have the following symptoms of high blood sugar.

  • Peeing more than usual
  • Feeling more hungry and thirsty than usual
  • Tiredness
  • Stomach upset
  • Fruity-smelling breath

Warnings & Precautions

Who should not take everolimus?

Allergies to Ingredients. People who are allergic to any of the following should not take everolimus.

  • Everolimus 
  • Sirolimus
  • Zortress
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific everolimus products they stock.

What should I know about everolimus before taking it?

Do not take everolimus unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share everolimus with other people, even if they have the same condition as you. It may harm them.

Keep everolimus out of the reach of children.

It is important to keep all appointments, including for lab appointments and bloodwork, before starting and while taking everolimus. 

Do not chew or crush everolimus tablets. They should be swallowed whole with a glass of water.

Everolimus may cause fertility problems. Tell your health care provider if you have questions or concerns about this.

What should I tell my health care provider before taking everolimus?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if everolimus is right for you.

In particular, make sure that you discuss any of the following.

Wound Healing Issues. Everolimus can make it hard for your body to heal from wounds. Tell your health care provider if your surgical wound is painful, swollen, bleeding, or leaking fluid. Let your health care provider know if you have any planned surgeries or if you get any injuries while taking everolimus.

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while taking everolimus. Tell your health care provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Everolimus may interact with other medicines and supplements. Before taking everolimus, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • Liver problems
  • Skin cancer, or if someone in your family has had skin cancer
  • High levels of fats in your blood (high cholesterol or triglycerides)
  • Diabetes
  • Infection
  • Blood clotting problems
  • Galactose intolerance, such as Lapp-lactase deficiency or glucose-galactose malabsorption

Heart Transplant. Everolimus is commonly used after a kidney or liver transplant. It may raise the risk of serious problems in some people who have had a heart transplant. Tell your health care provider about any other organ transplants you have had or plan to have. 

Pregnancy. Everolimus may harm an unborn baby. If you are able to get pregnant, you should use effective birth control while taking everolimus and for eight weeks after your last dose. Talk with your health care provider about birth control options. Tell your health care provider right away if you become pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if everolimus passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take everolimus while breastfeeding.

Interactions

Does everolimus interact with foods or drinks?

Food may affect how well your body absorbs everolimus. Take everolimus the same way each time, either with food or without food. This helps keep a steady level of the medicine in your blood, which helps everolimus work the way it should.

Grapefruit interacts with everolimus. Do not take everolimus with grapefruit or grapefruit juice. Grapefruit may increase the blood levels of everolimus, which can raise your risk of side effects.

It is unknown if drinking alcohol will affect everolimus. 

Does everolimus interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

In particular, make sure to discuss if you are using any of the following before taking everolimus.

  • Any other medicine that suppresses your immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune, and others) or a corticosteroid
  • A medicine for high blood pressure or heart problems, including diltiazem and verapamil
  • A medicine for HIV, AIDS, or hepatitis C
  • A medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin
  • A medicine for lowering the levels of fats in your blood (cholesterol or triglycerides)
  • An angiotensin-converting enzyme (ACE) inhibitor, such as enalapril or lisinopril, which is a medicine for high blood pressure, heart failure, and certain kidney problems
  • An antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Cannabidiol (Epidiolex), which is a medicine used for seizures, or a supplement that contains cannabidiol (CBD)
  • An antifungal medicine, such as fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • St. John's wort, which is a supplement that may be used for depression

Many other medicines may alter the blood levels of everolimus, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with everolimus. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much everolimus?

If you or someone else has taken too much everolimus, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of everolimus?

Missing doses of everolimus can cause it to not work as well. So it is important not to miss or skip doses. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

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