Rapamune (sirolimus) is a brand-name drug that’s prescribed to help prevent kidney transplant rejection and to treat a rare lung condition. It’s used in adults and certain children. As with other drugs, Rapamune can cause side effects.

Rapamune has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warnings for Rapamune” section.

Rapamune can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Rapamune in clinical trials:

Mild side effects can occur with Rapamune use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Rapamune’s prescribing information.

Mild side effects that have been reported with Rapamune include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Rapamune and want to tell the FDA about it, visit MedWatch.

Rapamune may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Rapamune’s prescribing information.

If you develop serious side effects while taking Rapamune, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • blood clotting problems, which may include symptoms such as:
    • bleeding that’s hard to stop
    • easy bruising or bleeding
    • unusual bleeding, such as nosebleeds, bleeding gums, or blood in the urine or stool
  • fertility problems, which may include symptoms such as:
    • difficulty getting pregnant
    • challenges making someone else pregnant
  • lung problems, which may include symptoms such as:
    • new or worsening cough
    • shortness of breath
    • trouble breathing
  • problems with wound healing, which may include symptoms such as:
    • slow healing or no healing at all
    • warmth, color changes, or swelling around a wound
    • wounds that continue to leak fluid or that heal but open up again
  • high blood pressure, which typically doesn’t cause symptoms
  • increased cholesterol and triglycerides, which typically doesn’t cause symptoms
  • risk of infection and cancer and risk with liver or lung transplants*
  • decline in kidney function†
  • serious swelling†

* For details about these risks, see the “Boxed warnings for Rapamune” section.
† For more information about this side effect, see the “Side effect specifics” section.

ALLERGIC REACTION

For some people, Rapamune can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Rapamune, your doctor may recommend taking a different medication instead.

Rapamune has boxed warnings about the risk of infection and cancer and risk with liver or lung transplants. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Be sure to talk with your doctor if you questions or concerns about these warnings.

Risk of infection and cancer

Rapapmune is an immunosuppressant. This means it can weaken your immune system. A weak immune system can help prevent your body from rejecting a kidney transplant. But it can also increase the risk of getting infections and developing cancers.

Taking Rapamune can increase the risk of getting bacterial, viral, or fungal infections, including:

Symptoms of PML and serious infections include:

  • confusion or difficulty thinking
  • difficulty with coordination or walking
  • weakness or paralysis on one side of your body
  • vision problems
  • speech difficulty
  • seizures

Taking Rapamune can also increase the risk of developing cancers. In clinical trials, lymphoma and skin cancers were common. Symptoms of cancer may include:

  • new or changing skin growths or moles
  • skin sores that aren’t healing
  • swollen lymph nodes in the neck, armpits, or other areas
  • unexplained weight loss

What you can do

If you have symptoms of PML or another serious infection, get medical care right away by calling 911 or your local emergency number.

You can help protect yourself from infections by taking these steps:

  • Keep away from crowds.
  • Avoid close physical contact with people who are sick.
  • Take care of yourself with a balanced diet and sleep routine.
  • Use your own personal items, such as towels and utensils.
  • Do not share personal items.
  • Wash your hands often with soap and water.

To help protect yourself from skin cancer, you can cover exposed skin in the sun and wear daily sunscreen. Avoid tanning beds and smoking.

If you develop a serious infection or cancer while taking Rapamune, your doctor may adjust your Rapamune dosage or change your treatment plan to help lower your risk. For infections like BK virus or PML, your doctor may reduce the strength of any other immunosupressant drug you may be taking.

For cancers, your doctor may suggest regular checkups, monitoring, or further tests like biopsies to guide treatment.

If you have concerns, talk with your doctor about how to monitor for these conditions during treatment.

Risk with liver or lung transplants

Rapamune may not be safe or effective in people with liver or lung transplants. In clinical trials, there was an increased risk of serious complications, including transplant failure and death, when taken during these types of transplants.

Due to the risk of increased complications and death, doctors typically don’t prescribe Rapamune for people who will have liver or lung transplants.

Talk with your doctor if you have questions or concerns about this warning.

Learn more about some of the side effects that Rapamune may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Rapamune.

Decline in kidney function

Rapamune may affect kidney function. In clinical trials, people who took Rapamune with cyclosporine (Gengraf, Neoral, Sandimmune) long term had a decline in kidney function. Doctors measured this with a blood test that measures serum creatinine.

Kidney function was also affected in people who were taking a calcineurin inhibitor drug, such as tacrolimus, and switched to Rapamune. Doctors measured this by checking the amount of protein in their urine. This change in kidney function was common in clinical trials of Rapamune.

Symptoms of kidney function decline include:

What you can do

Due to the risk of declining kidney function, doctors typically check kidney function during Rapamune treatment. This may include checking serum creatinine and urine protein levels on a regular basis.

If you also take cyclosporine, talk with your doctor about the possible effects on your kidney function. If you develop symptoms of kidney problems, tell your doctor right away.

Swelling

Rapamune may cause fluid to build up in your body, such as in your abdomen, lungs, or around your heart, which can make breathing or moving harder. It may also slow down wound healing, especially if you have overweight.

Rapamune can cause several types of swelling, some of which were very common in clinical trials. The following types of swelling were reported:

  • angioedema (swelling under the skin of the face, eyes, lips, mouth, tongue, or throat)
  • ascites (fluid buildup in the abdomen)
  • lymphedema (swelling due to a blockage in the lymph system that often affects an arm or leg)
  • peripheral edema (swelling due to fluid buildup in the hands, lower legs, or feet)
  • pleural or pericardial effusions (fluid buildup around the lungs or heart, which can cause chest pain and shortness of breath)

Peripheral edema was the most common side effect reported in clinical trials of Rapamune.

What you can do

Get medical care right away if you have shortness of breath, trouble breathing that feels serious, or swelling of your mouth or throat. You can call 911 or your local emergency number.

Tell your doctor if you have swelling in any body part or mild trouble breathing. They may recommend treatment to help reduce the swelling.

Rapamune may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Rapamune cause long-term side effects?

Yes, it’s possible. Some side effects of Rapamune can continue as long as you take the drug. Examples include a weakened immune system that increase the risk of infections and cancer. Fertility problems and high cholesterol and triglycerides may also continue for as long as you take the drug.

If you have side effects that aren’t going away, tell your doctor. They may be able to suggest ways to manage them. Also, talk with your doctor if you’re concerned about taking Rapamune long term.

Does low dose Rapamune cause side effects?

Yes, Rapamune can cause side effects at low doses. Side effects are generally dose related with Rapamune. This means they’ll be more likely to happen with higher doses, but they can still happen with lower doses. In clinical trials, the side effects were mostly the same for low dose Rapamune as they were at higher doses.

Talk with your doctor if you’re having side effects that are bothersome or are concerning. They may be able to suggest ways to manage them.

How do the side effects of Rapamune and tacrolimus compare?

Rapamune and tacrolimus share some side effects and have different ones. They’re both immunosuppressant drugs. But they belong to different drug classes. Rapamune belongs to a drug class called mammalian target of rapamycin (mTOR) inhibitors. Tacrolimus is a calcineurin inhibitor.

Both drugs can increase the risk of infection or developing cancer.* They can also cause problems with kidney function and swelling.†

Each drug also has side effects, both mild and serious, that the other doesn’t. To learn more about how these two drugs compare, talk with your doctor.

* For details about these side effects, see the “Boxed warnings for Rapamune” section.
† For more information about these side effects, see the “Side effect specifics” section.

Below is important information you should consider before taking Rapamune.

Rapamune has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warnings for Rapamune” section.

Other precautions

Before taking Rapamune, discuss your health history with your doctor. Rapamune may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • high cholesterol or triglycerides
  • liver problems
  • personal or family history of skin cancer
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.