Temsirolimus Side Effects

Medically reviewed by Drugs.com. Last updated on May 31, 2024.

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 side effects

• 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 side effects

• 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 side effects

• 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 side effects

• discouragement
• feeling sad or empty
• irritability
• loss of interest or pleasure
• tiredness
• trouble concentrating

For healthcare professionals

Applies to temsirolimus: intravenous solution.

Hepatic adverse events

• 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]

Further information

Temsirolimus side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer