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Side Effects

Along with its needed effects, a medicine 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:

More common

  • Bladder pain
  • Bloody nose
  • Bloody or cloudy urine
  • Body aches or pain
  • Chest pain
  • Congestion
  • Cough or hoarseness
  • Cracked lips
  • Diarrhea
  • Difficult or labored breathing
  • Difficult, burning, or painful urination
  • Difficulty with swallowing
  • Dryness or soreness of the throat
  • Fever or chills
  • Frequent urge to urinate
  • Headache
  • Lack or loss of strength
  • Lower back or side pain
  • Shortness of breath
  • Sneezing
  • Sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • 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
  • Wheezing

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • Convulsions
  • Dark-colored urine
  • Itching
  • Joint or muscle pain
  • 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

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Abdominal or stomach cramps
  • Black, tarry stools
  • Feeling that others are watching you or controlling your behavior
  • Feeling that others can hear your thoughts
  • Feeling, seeing, or hearing things that are not there
  • Loss of bladder control
  • Muscle spasm or jerking of all extremities
  • Severe mood or mental changes
  • Severe vomiting, sometimes with blood
  • Sudden loss of consciousness
  • Tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • Unusual behavior

Some side effects 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
  • Change in taste
  • Difficulty having a bowel movement (stool)
  • Difficulty with moving
  • Discoloration of the fingernails or toenails
  • Dry skin
  • Loss of appetite
  • Loss of taste
  • Nausea
  • Pain in the joints
  • Pimples
  • Rash
  • Sleeplessness
  • Swollen joints
  • Trouble with sleeping
  • Unable to sleep
  • Weight loss

Less common

  • Discouragement
  • Feeling sad or empty
  • Irritability
  • Loss of interest or pleasure
  • Tiredness
  • Trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during treatment with temsirolimus and for at least 3 months after stopping treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.

Temsirolimus may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.

This medicine may cause flushing, headaches, and lightheadedness or faintness, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Your doctor may give you insulin or other medicines that can lower the amount of sugar in your blood.

While you are being treated with temsirolimus, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Temsirolimus may lower your body’s resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal flu virus vaccine, measles, mumps, rubella, oral polio vaccine, BCG, yellow fever, varicella, or TY21a typhoid vaccine). Try to avoid being around persons who have received live vaccines. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Treatment with temsirolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

This medicine may cause a serious lung problem. Check with your doctor immediately if you are having tightness in the chest, shortness of breath, difficulty with breathing, or wheezing.

Temsirolimus may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; diarrhea; fever; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of having acute kidney disease that is not related to the worsening of your kidney cancer. Talk to your doctor about this risk.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before and after having surgery.

Grapefruit and grapefruit juice may increase the effects of temsirolimus by increasing the amount of medicine in your blood. You should not eat grapefruit or drink grapefruit juice while receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John’s wort) or vitamin supplements.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

You will receive a medicine to prevent allergic reactions (e.g., diphenhydramine, Benadryl®) before you receive this medicine.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of temsirolimus injection in the pediatric population. Safety and efficacy have not been established.


Appropriate studies on the relationship of age to the effects of temsirolimus injection have not been performed in the geriatric population. However, elderly patients are more likely to have diarrhea, edema (swelling), and pneumonia, which may require caution in patients receiving temsirolimus injection.


Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Carbamazepine
  • Clarithromycin
  • Dexamethasone
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Nefazodone
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Poliovirus Vaccine, Live
  • Rifabutin
  • Rifampin
  • Ritonavir
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Smallpox Vaccine
  • St John’s Wort
  • Telithromycin
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Voriconazole
  • Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Brain tumor—Use with caution. This medicine may increase the risk of having serious bleeding in the head.
  • Bowel problems or
  • Diabetes or
  • Hyperlipidemia (increased blood cholesterol or fats) or
  • Infection or
  • Kidney disease or
  • Liver disease, mild or
  • Lung disease (e.g., interstitial lung disease)—Use with caution. May make these conditions worse.
  • Liver disease, moderate and severe—Should not be used in patients with this condition.


Temsirolimus injection is an anticancer medicine that is used to treat advanced kidney cancer.

This medicine is available only with your doctor’s prescription.