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Sirolimus Side Effects

It is possible that some side effects of sirolimus may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sirolimus: oral solution, oral tablet

As well as its needed effects, sirolimus may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sirolimus, check with your doctor immediately:

More common
  • Abdominal or stomach cramps or pain
  • 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
  • convulsions (seizures)
  • 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
  • extreme fatigue
  • 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
  • mood changes
  • 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
  • sensation of pins and needles
  • severe constipation
  • severe vomiting
  • severe, sudden headache
  • shortness of breath
  • slurred speech
  • sore throat
  • sores or white spots on the lips or in the mouth
  • stomach pain or upset
  • sudden decrease in the amount of urine
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • 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
  • trouble breathing
  • 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 is size, shape, or color of existing mole
  • darkened urine
  • 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
  • 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

Some sirolimus side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 in passing urine (dribbling)
  • difficulty with moving
  • 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
  • itching skin
  • joint pain or swelling
  • kidney pain
  • leg cramps
  • loss of bladder control
  • loss of energy or weakness
  • loss of interest or pleasure
  • loss of strength
  • lower abdominal or stomach pain
  • mental depression
  • 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 with sleeping
  • waking to urinate at night

For Healthcare Professionals

Applies to sirolimus: oral solution, oral tablet


Respiratory side effects including dyspnea (22% to 30%), upper respiratory infection (20% to 26%), pharyngitis (16% to 21%), pleural effusion, and alveolar proteinosis have been reported. Cases of interstitial lung disease (including pneumonitis, and infrequently bronchiolitis obliterans organizing pneumonia and pulmonary fibrosis) with no identified infectious etiology and sometimes ending up being fatal have been reported. Bronchial anastomotic dehiscence has also been reported, including fatal cases in lung transplant patients treated with a combination of sirolimus, tacrolimus, and corticosteroids. Three cases of diffuse alveolar hemorrhage have been reported.[Ref]

It has been recommended that pulmonary toxicity due to sirolimus be included as a part of the differential diagnosis of kidney transplant patients who display signs of interstitial pneumonia.[Ref]


Metabolic side effects including peripheral edema (54% to 64%), hyperlipidemia (38% to 57%), hypercholesterolemia (35% to 46%), increased creatinine (35% to 40%), edema (16% to 24%), hypophosphatemia (15% to 23%), hypokalemia (11% to 21%), weight gain (8% to 21%), and hyperkalemia (12% to 17%) have been reported. High triglycerides have also been reported.[Ref]


Cardiovascular side effects including hypertension (39% to 49%) and chest pain (16% to 24%) have been reported. There have been reports of pericardial effusion (including hemodynamically significant effusions and tamponade requiring intervention in children and adults). A case of life-threatening coronary artery spasm following sirolimus-eluting stent deployment has also been reported.[Ref]


Gastrointestinal side effects including diarrhea (25% to 42%), constipation (28% to 38%), abdominal pain (28% to 36%), nausea (25% to 36%), vomiting (19% to 25%), dyspepsia (17% to 25%), and ascites have been reported. A case of sirolimus-induced intractable chronic diarrhea and a case of delayed gastric ulcer healing have also been reported.[Ref]


General side effects including asthenia (22% to 38%), fever (23% to 34%), headache (23% to 34%), and pain (24% to 33%) have been reported.[Ref]


Hematologic side effects including anemia (23% to 37%), thrombocytopenia (13% to 20%), leukopenia (9% to 15%), capillary leak syndrome, and lymphedema have been reported.[Ref]


Genitourinary side effects have included urinary tract infection, proteinuria, pyelonephritis, decline in renal function, ovarian cysts, and menstrual disorders (including amenorrhea and menorrhagia). Postmarketing reports have included nephrotic syndrome, focal segmental glomerulosclerosis, ovarian cysts, and menstrual disorders (including amenorrhea and menorrhagia). Azoospermia has also been reported during postmarketing and has generally been reversible upon discontinuation.[Ref]


Musculoskeletal side effects including arthralgia (25% to 31%) have been reported. A case of premature osteonecrosis and a case of myopathy have also been reported.[Ref]

Nervous system

Nervous system side effects including tremor (21% to 31%), insomnia (13% to 22%), and progressive multifocal leukoencephalopathy have been reported. A case of posterior reversible encephalopathy syndrome has also been reported.[Ref]


Dermatologic side effects including acne (20% to 31%), rash (10% to 20%), and exfoliative dermatitis have been reported. A case of chronic pyogenic periungual infection and a case of chylous ascites have also been reported.[Ref]


BK virus associated nephropathy has been associated with serious outcomes, including deteriorating renal function and renal graft loss.

Patients treated with cyclosporine and sirolimus were reported to have higher serum creatinine levels and lower glomerular filtration rates when compared to patients treated with cyclosporine and placebo or azathioprine controls. The rate of decline in renal function in these studies was greater in patients receiving sirolimus and cyclosporine compared with control therapies.

In patients with delayed graft function, sirolimus may delay recovery of renal function.[Ref]

Renal side effects have included BK virus associated nephropathy, nephrotic syndrome, higher serum creatinine levels, and lower glomerular filtration rates.[Ref]


The underlying mechanism for severe eyelid edema is unknown.[Ref]

Ocular side effects including severe eyelid edema have been reported.[Ref]


Hepatic side effects including hepatotoxicity and hepatic artery thrombosis have been reported. Abnormal liver function tests including increased AST/SGOT, increased ALT/SGPT, hypophosphatemia and hyperglycemia have also been reported.[Ref]


Hypersensitivity side effects including anaphylactic and anaphylactoid reactions, angioedema, and hypersensitivity vasculitis, have been reported.[Ref]


Other side effects including lymphedema, tuberculosis, and incisional hernia have been reported. A case of unilateral upper extremity edema has also been reported.[Ref]


Oncologic side effects have been reported in animal studies including lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.[Ref]


Endocrine side effects have included increased basal and stimulated insulin levels in vitro and insulin content in vitro regardless of culture duration.[Ref]


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

2. "Product Information. Rapamune (sirolimus)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

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

4. Morelon E, Stern M, Israel-Biet D, et al. "Characteristics of sirolimus-associated interstitial pneumonitis in renal transplant patients. transplantation 2001; 72: 787." Transplantation 72 (2001): 773-4

5. Morath C, Schwenger V, Ksoll-Rudek D, et al. "Four cases of sirolimus-associated interstitial pneumonitis: identification of risk factors." Transplant Proc 39 (2007): 99-102

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

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

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

9. Kaplan MJ, Ellis CN, Bata-Csorgo Z, Kaplan RS, Endres JL, Fox DA "Systemic toxicity following administration of sirolimus (formerly rapamycin) for psoriasis: association of capillary leak syndrome wit apoptosis of lesional lymphocytes." Arch Dermatol 135 (1999): 553-7

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

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

12. Moskowitz A, Nolan C, Lis E, Castro-Malaspina H, Perales MA "Posterior reversible encephalopathy syndrome due to sirolimus." Bone Marrow Transplant 39 (2007): 653-4

13. Raju DL, Bitzan M "Sirolimus-associated chronic pyogenic periungual infection." Kidney Int 71 (2007): 476

14. Castro G, Freitas C, Beirao I, Rocha G, Henriques AC, Cabrita A "Chylous ascites in a renal transplant recipient under sirolimus (rapamycin) treatment." Transplant Proc 40 (2008): 1756-8

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

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

17. Papali A, Giannetti N, Cantarovich M "Unilateral upper extremity edema associated with sirolimus in a heart transplant patient." Transplantation 83 (2007): 240

18. "Product Information. Torisel (temsirolimus)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

19. Marcelli-Tourvieille S, Hubert T, Moerman E, et al. "In vivo and in vitro effect of sirolimus on insulin secretion." Transplantation 83 (2007): 532-8

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