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Overview: Everolimus is used to treat certain types of cancers, tumors, and seizures. It works by helping to shrink tumors or slow their growth. Examples of common side effects include mouth sores, infections, rash, fatigue, and low appetite. Serious side effects may include lung inflammation, kidney damage, and an increased risk of infection. Everolimus comes as a tablet you swallow and a tablet that you dissolve in water.

Uses

What is everolimus used for?

Everolimus is commonly used for the following conditions.

These uses may vary depending on the specific everolimus product prescribed. 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 after an organ transplant. See Everolimus (Zortress) for more information.

How does everolimus work (mechanism of action)?

Everolimus works by blocking mTOR, a protein that controls cell growth and activity. Overactive signals from mTOR may cause some tumors and cancers to grow and spread. By blocking mTOR, everolimus can help shrink these tumors or slow the growth of cancer cells. 

People with tuberous sclerosis complex may have tumors in the kidney or brain due to an abnormal overgrowth of cells. By blocking mTOR, everolimus can help shrink these tumors or stop them from growing. Blocking mTOR may also help to reduce brain abnormalities and prevent seizures related to tuberous sclerosis complex.

How is everolimus supplied (dosage forms)?

Brands and other names

  • Afinitor
  • Afinitor Disperz

Dosage forms and strengths

  • 2.5 mg, 5 mg, 7.5 mg, 10 mg oral tablets
  • 2 mg, 3 mg, 5 mg tablets for oral suspension

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 transporting it. Store in a cool, dry place. Keep everolimus in its original container and protect it from moisture and 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 depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Mouth sores (see below)
  • Infections (see below)
  • Rash
  • Tiredness and weakness
  • Diarrhea, stomach pain, and nausea
  • Fluid retention
  • Nausea
  • Fever
  • Cough
  • Headache
  • Low appetite

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, especially when taken with certain other medicines
  • 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

Mouth Sores. Everolimus can commonly cause mouth sores (stomatitis), but they can sometimes be severe and affect your ability to eat, drink, or speak. Your health care provider may prescribe an alcohol-free mouthwash while you are taking everolimus to help prevent or limit mouth sores. Follow any advice from your health care provider about how to use mouthwash properly. Call your health care provider if you have any of the following symptoms in your mouth.

  • Pain, irritation, or redness 
  • Swelling 
  • Ulcers or sores

Metabolism Problems. Everolimus can increase the levels of fats in your blood, which may cause high cholesterol and triglycerides. This does not usually cause symptoms, but it can lead to serious health problems if left untreated. Everolimus can also cause high 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
  • Confusion
  • Fruity-smelling breath

Blood Disorders. Everolimus can cause blood disorders, such as low levels of red blood cells (anemia), low platelet levels, and low white blood cell levels. Keep all appointments with your health care provider to check your blood work. Call your health care provider right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infections
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Fast or abnormal heartbeat

Lung Inflammation. Everolimus can cause inflammation in your lungs (pneumonitis), which can be serious or even life-threatening. Get emergency help if you have trouble breathing, wheezing, or shortness of breath. You may also have a cough, fever, or chest pain.

Infections. Everolimus can increase your risk of infections, including serious infections that can be life-threatening. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever of 100.5 or higher
  • Sweats, chills, or muscle aches
  • Feeling more tired than usual
  • Sore throat
  • Cough or coughing up blood
  • Burning or stinging when you pee
  • Shortness of breath
  • Nausea, diarrhea, stomach pain, or loss of appetite
  • Weight loss

Kidney Damage. Kidney damage (acute kidney failure) can happen when taking everolimus. 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 than usual
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Trouble catching your breath or chest pain/pressure
  • Confusion
  • Nausea

Warnings & Precautions

Who should not take everolimus?

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

  • Afinitor
  • Afinitor Disperz
  • Everolimus
  • Sirolimus
  • Temsirolimus
  • 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.

Keep all appointments, including lab appointments and for blood work, before and after starting everolimus.

People who are 65 and older can be at greater risk for some side effects from everolimus. Talk to your health care provider about your risks if you are in this age group.

Everolimus tablets should not be cut or crushed. Swallow the tablets whole with a glass of water. Certain everolimus products must be dissolved in water before each dose. Read and follow the instructions that come with your medicine and make sure you understand how to prepare and take it properly. Ask your health care provider if you have any questions. 

Everolimus may cause fertility problems. Tell your health care provider if you have 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 determine 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 wounds. Tell your health care provider if you have any surgeries planned or if you have any injuries that occur while taking everolimus. 

Radiation. Tell your health care provider if you get radiation treatments, had radiation in the past, or have future radiation treatments planned. Taking everolimus may raise the risk of skin problems, inflamed lungs, or other reactions from radiation.

Vaccines. Talk with your health care provider about any vaccines that you may need before you start taking everolimus. You should not get certain vaccines while taking everolimus. You should also avoid close contact with people who have recently received certain vaccines. 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 or kidney problems
  • Infection
  • High levels of fats in your blood (high cholesterol or triglycerides)
  • High blood sugar levels or diabetes
  • Hepatitis B

Pregnancy. Everolimus may cause harm to an unborn baby. You must not be pregnant when taking everolimus. If you are able to get pregnant, you should use effective birth control while taking everolimus and for eight weeks after your last dose. If you are able to get a partner pregnant, you should use birth control (such as condoms) while taking everolimus and for four weeks after your last dose. Tell your health care provider right away if you become pregnant, think you might be pregnant, or plan to become pregnant. 

Breastfeeding. Do not breastfeed while taking everolimus and for two weeks after your last dose. It is not known if everolimus passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

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 raise the blood levels of everolimus, which can increase your risk of side effects.

It is unknown if drinking alcohol will affect everolimus. The risk of mouth sores may be increased if you drink alcohol while taking 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.

  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • Any other medicine that suppresses your immune system, such as tacrolimus (Envarsus XR, Prograf, and others) or a corticosteroid
  • A medicine for high blood pressure or heart problems
  • A medicine for HIV, AIDS, or hepatitis C
  • A medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • 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
  • 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. 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?

If you miss a dose, you can still take it up to six hours after your usual time. If you miss a dose by more than six hours, skip the missed dose. Continue taking your regular dose the next day at your usual time. Do not take double or extra doses. 

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