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

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]

References

1. "Product Information. Torisel (temsirolimus)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)