Temsirolimus Side Effects

It is possible that some side effects of temsirolimus 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 temsirolimus: intravenous solution

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

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

More common
  • Bladder pain
  • bloody nose
  • bloody or cloudy urine
  • body aches or pain
  • blurred vision
  • chest pain
  • chills
  • congestion
  • cough or hoarseness
  • cracked lips
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficulty with swallowing
  • dizziness
  • dryness or soreness of the throat
  • ear congestion
  • fever or chills
  • frequent urge to urinate
  • headache
  • joint or muscle pain
  • lack or loss of strength
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nervousness
  • numbness or tingling of the face, hands, or feet
  • pounding in the ears
  • runny nose
  • skin rash
  • slow or fast heartbeat
  • sneezing
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • sore throat
  • stomach pain
  • stuffy or runny nose
  • swelling of the hands, ankles, feet, or lower legs
  • swelling or puffiness of the face
  • tender, swollen glands in the neck
  • tightness in the chest
  • voice changes
  • vomiting
Less common
  • Abdominal or stomach cramps
  • black, tarry stools
  • bloody stools
  • changes in skin color
  • delayed wound healing
  • pain, tenderness, or swelling of the foot or leg
  • seizures
  • severe vomiting, sometimes with blood
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • convulsions
  • dark-colored urine
  • itching
  • muscle cramps or spasms
  • muscle stiffness
  • pain or redness at the injection site
  • pale skin at injection site
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • unusual tiredness or weakness

Some temsirolimus 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
  • Back pain
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in taste
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discharge or excessive tearing
  • discoloration of the fingernails or toenails
  • dry skin
  • loss of appetite
  • loss of taste
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • swollen joints
  • trouble sleeping
  • weight loss
Less common
  • Discouragement
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • tiredness
  • trouble concentrating

For Healthcare Professionals

Applies to temsirolimus: intravenous solution


Some patients with interstitial lung disease were asymptomatic with infiltrates detected on computed tomography scan or chest radiograph. Others presented with symptoms such as dyspnea, cough, hypoxia, and fever. Some patients required discontinuation of temsirolimus and/or treatment with corticosteroids and/or antibiotics, while other patients continued treatment without additional intervention. Patients should be advised to report promptly any new or worsening respiratory symptoms.

Respiratory side effects including dyspnea (28%), cough (26%), epistaxis (12%), pharyngitis (12%), rhinitis (10%), pneumonia (8%), and upper respiratory tract infection (7%) have been reported.

Interstitial lung disease has been reported in five patients (2%), including rare fatalities.


Hypersensitivity and allergic side effects (9%) have been reported.

Hypersensitivity reactions have included anaphylaxis, dyspnea, flushing, and chest pain. Temsirolimus should be used with caution in persons with known hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any other component (including the excipients) of temsirolimus.

An H1 antihistamine should be administered to patients before the start of the intravenous temsirolimus infusion. Temsirolimus should be used with caution in patients with known hypersensitivity to an antihistamine, or patients who cannot receive an antihistamine for other medical reasons.

If a patient develops a hypersensitivity reaction during the temsirolimus infusion, the infusion should be stopped and the patient should be observed for at least 30 to 60 minutes (depending on the severity of the reaction). At the discretion of the physician, treatment may be resumed with the administration of an H1-receptor antagonist (such as diphenhydramine), if not previously administered and/or an H2-receptor antagonist (such as intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the temsirolimus infusion. The infusion may then be resumed at a slower rate (up to 60 minutes).


Hematologic side effects including decreased hemoglobin (94%), decreased lymphocytes (53%), decreased platelets (40%), decreased leukocytes (32%), and decreased neutrophils (19%) have been reported.


Other side effects including laboratory abnormalities have been reported in 100% of patients. Blood chemistry abnormalities have included increased glucose (89%), increased total cholesterol (87%), increased triglycerides (83%), increased alkaline phosphatase (68%), increased creatinine (57%), decreased phosphorus (49%), increased AST (38%), decreased potassium (21%), and increased total bilirubin (8%).


General side effects including asthenia (51%), edema (35%), pain (28%), pyrexia (24%), weight loss (19%), chest pain (16%), headache (15%), chills (8%), and impaired wound healing (1%) have been reported.

Because temsirolimus has been associated with abnormal wound healing, caution should be exercised with the use of temsirolimus in the perioperative period.


Cases of fatal bowel perforation have been reported in patients who received temsirolimus. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen. Patients should be advised to report promptly any new or worsening abdominal pain or blood in their stools.

Gastrointestinal side effects including mucositis (41%), nausea (37%), anorexia (32%), diarrhea (27%), abdominal pain (21%), constipation (20%), and vomiting (19%) have been reported. Fatal bowel perforation has also been.


Genitourinary side effects including urinary tract infection (15%) have been reported.


Renal side effects including cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression have been reported.

Some of these cases of rapidly progressive acute renal failure were not responsive to dialysis.


Musculoskeletal side effects including back pain (20%), arthralgia (18%), and myalgia (8%) have been reported.


Dermatologic side effects including rash (47%) pruritus (19%), nail disorder (14%), dry skin (11%), and acne (10%) have been reported.

Nervous system

Nervous system side effects including dysgeusia (including taste loss and taste perversion) (20%), insomnia (12%), and depression (4%) have been reported.


Ocular side effects such as conjunctivitis (including lacrimation disorder) (7%) have been reported.


Cardiovascular side effects including hypertension (7%), venous thromboembolism (including deep vein thrombosis and pulmonary embolus) (2%) and thrombophlebitis (1%) have been reported.


Oncologic side effects have not been reported with temsirolimus. However, animal studies have reported sirolimus (the major metabolite of temsirolimus in humans) to be carcinogenic. The following effects have been reported in animals in the carcinogenicity studies conducted with sirolimus: lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.


Increases in serum glucose may result in the need for an increase in the dose of, or the initiation of, insulin and/or oral hypoglycemic agent therapy. Serum glucose should be tested before and during treatment with temsirolimus. Patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.

Increases in serum triglycerides and cholesterol may require the initiation of, or increase in the dose of lipid-lowering agents. Serum cholesterol and triglycerides should be tested before and during treatment with temsirolimus.

Metabolic side effects including increases in serum glucose are likely. In a phase 3 trial, 89% of patients receiving temsirolimus had at least one elevated serum glucose while on treatment, and 26% of patients reported hyperglycemia as an adverse event.

The use of temsirolimus is also likely to result in increases in serum triglycerides and cholesterol. In a phase 3 trial, 87% of patients receiving temsirolimus had at least one elevated serum cholesterol value and 83% had at least one elevated serum triglyceride value.

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