Summary
Commonly reported side effects of sirolimus include: upper respiratory tract infection and urinary tract infection. Continue reading for a comprehensive list of adverse effects.
Applies to sirolimus: oral solution, oral tablet.
Warning
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 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:
More common
- Accumulation of pus
- anxiousness, unexplained
- backache
- black or red, tarry stools
- bleeding from the gums or nose
- blurred vision
- body aches or pain
- bone pain
- bruising
- burning or stinging of the skin
- burning while urinating
- burning, dry, or itching eyes
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- change in mental status
- changes in skin color
- chest pain
- chills
- confusion
- cough
- dark or bloody urine
- deafness
- decreased urine output
- decreased vision
- difficulty with breathing or swallowing
- dilated neck veins
- discharge from the eyes
- dizziness
- drowsiness
- dry mouth
- earache
- excessive tearing
- eye pain
- facial hair growth in females
- faintness or lightheadedness when getting up from lying or sitting position
- fast, slow, or irregular heartbeat
- fever
- flushing or redness of the skin, especially on the face and neck
- general feeling of discomfort or illness
- increased hunger
- increased menstrual flow or vaginal bleeding
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- lack or loss of appetite
- large, flat, blue, or purplish patches in the skin
- loss of sexual ability, desire, drive, or performance
- loss of voice
- muscle pain
- nasal congestion
- nausea or vomiting
- numbness or tingling around the lips, hands, or feet
- pain in the chest, groin, or legs, especially the calves
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pale skin
- prolonged bleeding from cuts
- rapid heartbeat
- rash
- red or dark brown urine
- redness or swelling in the ear
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- ringing in the ears
- runny nose
- seizures
- sensation of pins and needles
- severe constipation
- severe vomiting
- severe, sudden headache
- slurred speech
- sore throat
- sores or white spots on the lips or in the mouth
- stomach cramps, pain, or upset
- sudden decrease in the amount of urine
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
- tremor
- ulcers on the lips or in the mouth
- unusual tiredness or weakness
- vision changes
- weakness or heaviness of the legs
- white patches in the mouth or on the tongue
- yellow skin and eyes
Less common
- Bloating
- change in size, shape, or color of existing mole
- hoarseness
- mole that leaks fluid or bleeds
- new mole
- pains in the stomach, side or abdomen, possibly radiating to the back
- skin ulcer or sores
Incidence not known
- Abnormal wound healing
- headache
- hives or itching
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nails loose or detached
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- swelling of the arms or legs
- yellow nails lacking a cuticle
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:
More common
- Abnormal vision
- acne
- belching
- blistering, crusting, irritation, itching, or reddening of the skin
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feeling
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, or scaly skin
- crying
- decrease in frequency of urination
- degenerative disease of the joint
- depersonalization
- diarrhea
- difficulty with moving
- difficulty with passing urine (dribbling)
- dysphoria
- ear pain
- enlarged abdomen or stomach
- euphoria
- excess air or gas in the stomach or intestines
- excessive muscle tone, muscle tension or tightness
- fear
- feeling sad or empty
- hearing loss
- heartburn
- inability to have or keep an erection
- increase in heart rate
- increased hair growth, especially on the face
- increased urge to urinate during the night
- indigestion
- irritation in the mouth
- joint pain or swelling
- leg cramps
- loss of bladder control
- loss of energy or weakness
- loss of interest or pleasure
- loss of strength
- lower abdominal or stomach pain
- muscle aches, pain, stiffness, or weakness
- nervousness
- pain in the back, ribs, arms, or legs
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- paranoia
- pelvic pain
- quick to react or overreact emotionally
- rapid breathing
- rapidly changing moods
- inflammation, redness, or swelling of the gums or mouth
- shaking or trembling
- shivering
- sleepiness
- sunken eyes
- swelling
- swelling of the scrotum
- tender or enlarged gums
- tenderness in the stomach area
- thickening of the skin
- trouble concentrating
- trouble sleeping
- waking to urinate at night
For Healthcare Professionals
Applies to sirolimus: oral solution, oral tablet.
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]
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]
General
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]
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]
