Note: This document contains side effect information about temsirolimus. Some dosage forms listed on this page may not apply to the brand name Torisel.

Applies to temsirolimus: intravenous solution.

Serious side effects of Torisel

Along with its needed effects, temsirolimus (the active ingredient contained in Torisel) 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 or nurse immediately if any of the following side effects occur while taking temsirolimus:

More common

• Bladder pain
• bloody nose
• bloody or cloudy urine
• body aches or pain
• blurred vision
• chest pain
• chills
• congestion
• cough
• 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
• frequent urge to urinate
• headache
• hoarseness
• 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

• 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
• stomach cramp
• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Blistering, peeling, or loosening of the skin
• dark-colored urine
• itching
• muscle cramps, spasms, or 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

Other side effects of Torisel

Some side effects of temsirolimus 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

• Back pain
• blemishes on the skin
• burning, dry, or itching eyes
• change in taste
• difficulty having a bowel movement
• 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.

Hepatic

Very common (10% or more): Increased AST (up to 38%)

Common (1% to 10%): Increased total bilirubin, increased ALT^[Ref]

Immunologic

Very common (10% or more): Bacterial and viral infections (including abscess, bronchitis, cellulitis, herpes simplex, oral herpes, herpes zoster; up to 28.3%)

Common (1% to 10%): Sepsis, candidiasis, fungal infection, flu syndrome^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic/hypersensitivity reactions^[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 28%), cough (up to 29%), epistaxis (up to 21.5%), pharyngitis (up to 12%), pneumonia (up to 10.9%), rhinitis (up to 10%)

Common (1% to 10%): Upper respiratory tract infection, pleural effusion, sinusitis, interstitial lung disease/pneumonitis (including fatalities)

Uncommon (0.1% to 1%): Laryngitis

Postmarketing reports: Pneumocystis jiroveci pneumonia^[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 57%)

Common (1% to 10%): Renal failure^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 94%), decreased lymphocytes (up to 53%), anemia (up to 41.1%), decreased platelets (up to 40%), decreased leukocytes (up to 32%), thrombocytopenia (up to 30.2%), decreased neutrophils (up to 19%), neutropenia (up to 14.3%)

Common (1% to 10%): Leukopenia, lymphopenia^[Ref]

Cardiovascular

Very common (10% or more): Chest pain (up to 16%)

Common (1% to 10%): Hypertension, venous thromboembolism (including deep vein thrombosis and pulmonary embolism, some fatal), thrombophlebitis, pericardial effusion^[Ref]

Dermatologic

Very common (10% or more): Rash (including eczema, exfoliative dermatitis, maculopapular rash, pustular rash, vesiculobullous rash; up to 47%), pruritus (up to 21.5%), nail disorder (up to 14%), dry skin (up to 11%), acne (up to 10%)

Common (1% to 10%): Folliculitis, ecchymosis, petechiae

Postmarketing reports: Stevens-Johnson syndrome^[Ref]

Other

Very common (10% or more): Asthenia (up to 51%), fatigue (up to 41.4%), edema (including facial and peripheral; up to 38%), pyrexia (up to 28.3%), pain (up to 28%)

Common (1% to 10%): Wound infection/post-operative wound infection, impaired wound healing

Postmarketing reports: Angioneurotic edema-type reactions, extravasations^[Ref]

Endocrine

Very common (10% or more): Increased glucose (up to 89%), hyperglycemia (up to 26%)

Common (1% to 10%): Diabetes mellitus^[Ref]

Gastrointestinal

Very common (10% or more): Mucositis (including stomatitis, glossitis, mouth ulceration; up to 41%), nausea (up to 37%), diarrhea (up to 34%), abdominal pain (up to 21%), constipation (up to 20%), vomiting (up to 19%)

Common (1% to 10%): Bowel perforation (including fatal cases), gastrointestinal hemorrhage, rectal hemorrhage, gastritis, dysphagia, abdominal distension, oral pain, gingivitis, mouth pain, oral moniliasis, hemorrhoidal hemorrhage

Uncommon (0.1% to 1%): Intestinal/duodenal perforation, lip hemorrhage, mouth hemorrhage^[Ref]

Genitourinary

Very common (10% or more): Unspecified urogenital adverse reaction (up to 30%), urinary tract infection (including cystitis, dysuria, hematuria, urinary frequency; up to 15%)^[Ref]

Metabolic

Very common (10% or more): Increased total cholesterol (up to 87%), increased triglycerides (up to 83%), increased alkaline phosphatase (up to 68%), decreased phosphorus (up to 49%), decreased calcium (up to 39%), decreased appetite (up to 33.3%), anorexia (up to 32%), hyperlipidemia (up to 27%), decreased potassium (up to 21%), weight loss (up to 19%), hypercholesterolemia (up to 18.8%), hypertriglyceridemia (up to 17.4%), hypokalemia (up to 13.7%), increased lactic dehydrogenase (up to 11%)

Common (1% to 10%): Dehydration, hypocalcemia, hypophosphatemia^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 20%), arthralgia (up to 18%), muscle cramp (up to 12%)

Common (1% to 10%): Myalgia

Postmarketing reports: Rhabdomyolysis^[Ref]

Nervous system

Very common (10% or more): Dysgeusia (including taste loss, taste perversion; up to 20%), headache (up to 17.1%)

Common (1% to 10%): Dizziness, paresthesia, somnolence, convulsion

Uncommon (0.1% to 1%): Intracranial hemorrhage

Postmarketing reports: Complex regional pain syndrome/reflex sympathetic dystrophy^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis (including lacrimation disorder)

Uncommon (0.1% to 1%): Eye hemorrhage^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 14%)

Common (1% to 10%): Depression, anxiety^[Ref]