Applies to temsirolimus: intravenous solution.
Serious side effects of Temsirolimus
Along with its needed effects, temsirolimus 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 Temsirolimus
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]
