Sirolimus Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 13, 2025.

Applies to sirolimus: oral solution, oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant, and keep using it for at least 12 weeks after you stop taking sirolimus. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are planning to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Sirolimus may cause serious types of allergic reactions, including anaphylaxis,, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child has a rash, itching, red, swollen skin, trouble breathing, trouble swallowing, or chest tightness while you are using this medicine.

Sirolimus may cause a serious type of allergic reaction called angioedema. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (eg, captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], ramipril [Altace®]). Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, or chest tightness while you are using this medicine.

This medicine may also increase your risk of bleeding and cause delay in wound healing. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you or your child has bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may cause a serious lung problem called interstitial lung disease or non-infectious pneumonitis. Check with your doctor right away if you have chest pain, chills, cough, fever, or trouble breathing.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you or your child has vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds.

While you are being treated with sirolimus, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations (vaccines) without your doctor's approval. Sirolimus may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if you notice a new mole, a change in size, shape or color of an existing mole, or a mole that leaks fluid or bleeds.

While you are taking sirolimus, it is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.

Raw oysters or other shellfish may contain bacteria that can cause serious illness and possibly death. This is more likely to be a problem if these foods are eaten by patients with certain medical conditions. Even eating oysters from “clean” water or good restaurants does not guarantee that the oysters do not contain the bacteria. Eating raw shellfish is not a problem for most healthy people, however, patients with the following conditions may be at greater risk: cancer, immune disorders, organ transplantation, long-term corticosteroid use (as for asthma, arthritis, or organ transplantation), liver disease (including viral hepatitis), excess alcohol intake (2 to 3 drinks or more per day), diabetes, stomach problems (including stomach surgery and low stomach acid), and hemochromatosis (an iron disorder). Do not eat raw oysters or other shellfish while you are taking sirolimus. Be sure oysters and shellfish are fully cooked.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of sirolimus

Along with its needed effects, sirolimus 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:

Other side effects of sirolimus

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:

For healthcare professionals

Applies to sirolimus: oral solution, oral tablet.

General adverse events

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]

Metabolic

• 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]

Cardiovascular

• 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]

Gastrointestinal

• 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]

Respiratory

• 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]

Hematologic

• 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]

Genitourinary

• 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]

Musculoskeletal

• 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]

Dermatologic

• 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]

Renal

• 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]

Ocular

• Frequency not reported: Eyelid edema^[Ref]

Hepatic

• Common (1% to 10%): Liver function tests abnormal
• Frequency not reported: Hepatic failure, hepatic artery thrombosis^[Ref]

Hypersensitivity

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

Other

• Very common (10% or more): Fever (up to 34%), pain (up to 29%)
• Common (1% to 10%): Impaired healing^[Ref]

Oncologic

• Common (1% to 10%): Skin cancer, lymphoma/post-transplant lymphoproliferative disorder
• Frequency not reported: Hepatocellular adenoma and carcinoma, testicular adenoma^[Ref]

Immunologic

• 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]

See also:

Further information

Sirolimus side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer