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Rapamune Side Effects

Generic name: sirolimus

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 13, 2024.

Note: This document contains side effect information about sirolimus. Some dosage forms listed on this page may not apply to the brand name Rapamune.

Applies to sirolimus: oral solution, oral tablet.


Oral route (Solution; Tablet)

Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppressionIncreased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus for prophylaxis of organ rejection in patients receiving renal transplants. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended.Liver Transplantation - Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis (HAT)The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death. In this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death.Lung Transplantation - Bronchial Anastomotic DehiscenceCases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.

Serious side effects of Rapamune

Along with its needed effects, sirolimus (the active ingredient contained in Rapamune) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sirolimus:

More common

Less common

Incidence not known

Other side effects of Rapamune

Some side effects of sirolimus may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to sirolimus: oral solution, oral tablet.


Very common (10% or more): Dyspnea (up to 30%), upper respiratory infection (up to 26%), pharyngitis (up to 21%)

Common (1% to 10%): Pneumonia, epistaxis, pleural effusion, epistaxis

Uncommon (0.1% to 1%): Pulmonary hemorrhage

Rare (less than 0.1%): Alveolar proteinosis

Frequency not reported: Pleural effusion, alveolar proteinosis[Ref]


Very common (10% or more): Hypertriglyceridemia (up to 58%), hypercholesterolemia (up to 46%), hypokalemia, hypophosphatemia, hyperglycemia

Common (1% to 10%): Abnormal healing, increased lactic dehydrogenase (LDH), hypokalemia, diabetes mellitus[Ref]


Very common (10% or more): Peripheral edema (up to 58%), hypertension (up to 49%), chest pain (up to 24%), edema (up to 18%), lymphocele

Common (1% to 10%): Venous thromboembolism (including pulmonary embolism, deep venous thrombosis), tachycardia

Uncommon (0.1% to 1%): Pericardial effusion (including hemodynamically significant effusions in children and adults), lymphedema

Rare (less than 0.1%): Pericardial effusion[Ref]


Very common (10% or more): Constipation (up to 38%), abdominal pain (up to 36%), diarrhea (up to 35%), nausea (up to 31%), vomiting (up to 25%), dyspepsia (up to 25%)

Common (1% to 10%): Stomatitis[Ref]


The most common adverse reactions associated with this drug are peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, constipation, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia.[Ref]


Very common (10% or more): Anemia (up to 33%), thrombocytopenia (up to 30%), blood lactate dehydrogenase increased, blood creatinine increased

Common (1% to 10%): Thrombocytopenic purpura/hemolytic uremic syndrome, leukopenia, neutropenia, aspartate aminotransferase increased, alanine aminotransferase increased

Uncommon (0.1% to 1%): Pancytopenia

Frequency not reported: Capillary leak syndrome[Ref]


Very common (10% or more): Urinary tract infection (up to 33%)

Common (1% to 10%): Pyelonephritis, decline in renal function (creatinine increased) in long-term combination of cyclosporine with this drug, ovarian cysts, menstrual disorders (including amenorrhea and menorrhagia), proteinuria

Postmarketing reports: Azoospermia[Ref]


Very common (10% or more): Arthralgia (up to 31%)

Common (1% to 10%): Bone necrosis[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)

Common (1% to 10%): Osteonecrosis, tremor, insomnia[Ref]


Very common (10% or more): Acne (up to 22%), rash (up to 20%)

Common (1% to 10%): Herpes zoster, herpes simplex

Uncommon (0.1% to 1%): Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), leukopenia, melanoma, squamous cell carcinoma, basal cell carcinoma[Ref]


Very common (10% or more): Creatinine increased (up to 40%)

Uncommon (0.1% to 1%): Nephrotic syndrome

Frequency not reported: Focal segmental glomerulo-sclerosis, BK virus associated nephropathy, nephrotic syndrome, higher serum creatinine levels, lower glomerular filtration rates[Ref]


Frequency not reported: Eyelid edema[Ref]


Common (1% to 10%): Liver function tests abnormal

Frequency not reported: Hepatic failure, hepatic artery thrombosis[Ref]


Rare (less than 0.1%): Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis[Ref]


Very common (10% or more): Fever (up to 34%), pain (up to 29%)

Common (1% to 10%): Impaired healing[Ref]


Common (1% to 10%): Skin cancer, lymphoma/post-transplant lymphoproliferative disorder

Frequency not reported: Hepatocellular adenoma and carcinoma, testicular adenoma[Ref]


Common (1% to 10%): Sepsis, pneumonia, pyelonephritis, herpes simplex, fungal, viral, and bacterial infections (such as mycobacterial infections, including tuberculosis, Epstein-Barr virus, CMV, and Herpes zoster), mycobacterial infections (including M tuberculosis), cytomegalovirus (CMV), Epstein-Barr virus

Frequency not reported: Clostridium difficile enterocolitis[Ref]


1. (2001) "Product Information. Rapamune (sirolimus)." Wyeth-Ayerst Laboratories

2. Vlahakis NE, Rickman OB, Morgenthaler T (2004) "Sirolimus-associated diffuse alveolar hemorrhage." Mayo Clin Proc, 79, p. 541-5

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online.

5. Sola E, Lopez V, Burgos D, et al. (2006) "Pulmonary toxicity associated with sirolimus treatment in kidney transplantation." Transplant Proc, 38, p. 2438-40

6. Wheatcroft S, Byrne J, Thomas M, MacCarthy P (2006) "Life-threatening coronary artery spasm following sirolimus-eluting stent deployment." J Am Coll Cardiol, 47, 1911-2; author reply 1912-3

7. Alkhatib AA (2006) "Sirolimus-induced intractable chronic diarrhea: a case report." Transplant Proc, 38, p. 1298-300

8. Altomare JF, Smith RE, Potdar S, Mitchell SH (2006) "Delayed gastric ulcer healing associated with sirolimus." Transplantation, 82, p. 437-8

9. Aboujaoude W, Milgrom ML, Govani MV (2004) "Lymphedema associated with sirolimus in renal transplant recipients1." Transplantation, 77, p. 1094-6

10. Josef F, Marina K, Alois W (2003) "Sirolimus myopathy." Transplantation, 76, p. 1773-4

11. Mohaupt MG, Vogt B, Frey FJ (2001) "Sirolimus-associated eyelid edema in kidney transplant recipients." Transplantation, 72, p. 162-4

12. Neff GW, Ruiz P, Madariaga JR, et al. (2004) "Sirolimus-associated hepatotoxicity in liver transplantation." Ann Pharmacother, 38, p. 1593-6

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.