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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

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]

References

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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

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

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

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

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

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

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

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