Temodar Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Temodar reports: 218.
Temodar FDA safety alerts: No.
Reported deaths: 70 Reported hospitalizations: 133.
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FDA Reported Temodar Side Effects: pancytopenia, dehydration, death, disease progression, thrombocytopenia, platelet count decreased, pneumonia, fatigue, asthenia, white blood cell count decreased, bone marrow failure.
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Temodar Side Effects Report #5425866-8Consumer or non-health professional from UNITED STATES reported TEMODAR problem on Aug 15, 2007. Female patient, 62 years of age, was diagnosed with brain neoplasm and was treated with TEMODAR. TEMODAR dosage: 270 MG;QD;PO. Patient died on 08/08/2007.
Temodar Side Effects Report #5428479-7
TEMODAR problem was reported by a Physician from UNITED STATES on Aug 22, 2007. Female patient, 79 years of age, weighting 173.9 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: arrhythmia supraventricular, atrial fibrillation, bone marrow failure, dyspnoea, nodal arrhythmia, palpitations, pancytopenia, sick sinus syndrome, urinary tract infection. TEMODAR dosage: 75 MG/M2; QD; PO, 150 MG/M2; QD; PO, 200 MG/M2; QD; PO. During the same period patient was treated with VITAMIN CAP. Patient was hospitalized. Patient died on 07/15/2007.
Temodar Side Effects Report #5428894-1
Consumer or non-health professional from UNITED STATES reported TEMODAR problem on Aug 21, 2007. Female patient, 78 years of age, was diagnosed with malignant melanoma and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: blood potassium increased, decreased appetite, dehydration, dizziness, dysgeusia, erythema, fatigue, nausea, paraesthesia. TEMODAR dosage: unknown. During the same period patient was treated with NEXAVAR. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5429149-1
TEMODAR problem was reported by a Health Professional from UNITED STATES on Aug 20, 2007. Female patient, 65 years of age, weighting 141.0 lb, was diagnosed with malignant melanoma and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, platelet count decreased, pneumonia, white blood cell count decreased. TEMODAR dosage: 170 MG;QD;PO. During the same period patient was treated with TRENTAL, LUTEIN, CALCIUM CARBONATE, VITAMIN D. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5442064-2
Consumer or non-health professional from UNITED STATES reported TEMODAR problem on Aug 23, 2007. Male patient, 71 years of age, weighting 235.9 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: hyponatraemia, neutropenia. TEMODAR dosage: 200 MG/M2; ;PO. During the same period patient was treated with IRINOTECAN, DEXAMETHASONE, BENASEPRIL, ZANTAC, FINASTERIDE, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5443089-3
TEMODAR problem was reported by a Health Professional from UNITED STATES on Aug 24, 2007. Male patient, 68 years of age, weighting 218.3 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, arrhythmia supraventricular, atrial fibrillation, clostridium difficile colitis, dehydration, hyperglycaemia, hypotension, pancytopenia, renal failure acute. TEMODAR dosage: 200 MG/M2; QD; PO. During the same period patient was treated with IRINOTECAN, COUMADIN, LOTREL, LASIX, TOPROL, DECADRON, LIPITOR. Patient was hospitalized. Patient died on 08/02/2007.
Temodar Side Effects Report #5444141-9
Physician from UNITED STATES reported TEMODAR problem on Aug 27, 2007. Female patient, 64 years of age, was diagnosed with brain neoplasm and was treated with TEMODAR. TEMODAR dosage: unknown. Patient died on 08/05/2007.
Temodar Side Effects Report #5445705-9
TEMODAR problem was reported by a Health Professional from UNITED STATES on Aug 27, 2007. Female patient, 51 years of age, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis. TEMODAR dosage: 140 MG; QD; PO. Patient recovered.
Temodar Side Effects Report #5450679-0
Physician from UNITED STATES reported TEMODAR problem on Sept 05, 2007. Female patient, 66 years of age, was diagnosed with brain neoplasm malignant and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: breast cancer female. TEMODAR dosage: 140 MG; PO, 150 MG; ; PO. Patient recovered.
Temodar Side Effects Report #5455621-4
TEMODAR problem was reported by a Physician from UNITED STATES on Sept 07, 2007. Male patient, 56 years of age, weighting 153.4 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: colitis, computerised tomogram abdomen abnormal, confusional state, constipation, deep vein thrombosis, gastrointestinal disorder, hypotension, leukocytosis, neutropenic sepsis. TEMODAR dosage: 200 MG/M2; PO. During the same period patient was treated with IRINOTECAN, VERAPAMIL, ASPIRIN, DEXAMETHASONE, DEPAKOTE, KLONOPIN. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5457859-9
Physician from UNITED STATES reported TEMODAR problem on Sept 10, 2007. Male patient, 74 years of age, weighting 190.0 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: anorexia, balance disorder, decreased appetite, dehydration, fatigue, headache, malaise. TEMODAR dosage: unknown. During the same period patient was treated with DILANTIN, FLOMAX, COLACE, VICODIN, LEXAPRO, SINGULAIR, DOXYCYCLINE. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5457884-8
TEMODAR problem was reported by a Physician from UNITED STATES on Sept 10, 2007. Female patient, 57 years of age, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: pneumonia. TEMODAR dosage: 150 MG/M2; ; PO. During the same period patient was treated with IRINOTECAN, PROTONIX, KEPPRA, DEXAMETHASONE, PHENOBARBITAL, DECADRON. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5463822-4
Health Professional from UNITED STATES reported TEMODAR problem on Sept 11, 2007. Female patient, 65 years of age, weighting 141.0 lb, was diagnosed with malignant melanoma and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, platelet count decreased, pneumonia, white blood cell count decreased. TEMODAR dosage: 170 MG;QD;PO. During the same period patient was treated with SUTENT, TRENTAL, LUTEIN, CALCIUM CARBONATE. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5465309-1
TEMODAR problem was reported by a Physician from UNITED STATES on Sept 14, 2007. Male patient, 74 years of age, weighting 190.0 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: anorexia, balance disorder, dehydration, fatigue, headache, malaise. TEMODAR dosage: 160 MG; QD; PO, 160 MG; QD; PO. During the same period patient was treated with DILANTIN, FLOMAX, COLACE, VICODIN, LEXAPRO, SINGULAIR, DOXYCYCLINE. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5467590-1
Consumer or non-health professional from UNITED STATES reported TEMODAR problem on Sept 17, 2007. Male patient, 84 years of age, was diagnosed with malignant melanoma and was treated with TEMODAR. TEMODAR dosage: 100 MG. Patient died on 08/11/2007.
Temodar Side Effects Report #5472197-6
TEMODAR problem was reported by a Physician from UNITED STATES on Sept 19, 2007. Female patient was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: convulsion. TEMODAR dosage: unknown. Patient died.
Temodar Side Effects Report #5472375-6
Physician from UNITED STATES reported TEMODAR problem on Sept 17, 2007. Male patient, 47 years of age, weighting 240.3 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: atelectasis, cerebral ventricle dilatation, device malfunction, device related infection, glioblastoma multiforme, lobar pneumonia, malignant neoplasm progression, meningitis, surgical procedure repeated. TEMODAR dosage: 200 MG/M2; QD; PO. During the same period patient was treated with IRINOTECAN, DECADRON, LORTAB, CELEXA, ZOFRAN, PEPCID, IMODIUM. Patient was hospitalized. Patient recovered.
Temodar Side Effects Report #5474619-3
TEMODAR problem was reported by a Physician from UNITED STATES on Sept 25, 2007. Female patient, 66 years of age, weighting 197.0 lb, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: breast cancer female. TEMODAR dosage: 140 MG; PO, 150 MG; PO, 150 MG, PO. Patient recovered.
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Drug Information: Temozolomide
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601250.html
(te moe zoe' loe mide)About your treatment
Your doctor has ordered the drug temozolomide to help treat your illness. This medication is used to treat brain tumors (astrocytoma). The drug is taken by mouth in capsule form. Your full dose may contain two or more different strengths of temozolomide capsules. Take your dose at bedtime, with a full glass of water, on an empty stomach. Do not chew or open the capsules. If a capsule opens or breaks, be careful not to get the contents on the skin around your eyes, nose, or mouth. Temozolomide is usually given once daily for 5 days. The treatment may be repeated every 28 days.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Temozolomide is in a class of drugs known as imidazotetrazine derivatives. It slows or stops the growth of cancer cells in your body. The length of treatment depends on how well your body responds to the treatment.
Precautions
Before taking temozolomide,
- tell your doctor and pharmacist if you are allergic to temozolomide, dacarbazine, or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including herbal products and vitamins.
- tell your doctor if you have or have ever had kidney or liver disease.
- you should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for further details.) Use a reliable method of birth control to prevent pregnancy. Temozolomide may harm the fetus.
- tell your doctor if you are breast-feeding.
- do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.
- be aware that temozolomide has been associated with the development of other types of cancer. Talk to your doctor about the potential risk of developing a new cancer.
Side effects
Side effects from temozolomide are common and include:
- nausea
- vomiting
- diarrhea
- stomach pain and cramps
- headache
- numbness
- weakness
- tiredness
- back pain
- dizziness
- difficulty walking or coordinating movement
- vision changes
- loss of appetite
- fever
- swelling of the hands, feet, ankles, or lower legs
- weight gain
- constipation
- discoloration of the skin
- hair loss
- nose bleeds
- fatigue
- confusion
- anxiety
- difficulty falling or staying asleep
- urinary incontinence
- breast pain in women
If you experience any of the following symptoms, call your doctor immediately:
- unusual bleeding or bruising
- rash
- itching
- difficulty breathing or swallowing
- seizures
- infection
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Storage conditions
Keep temozolomide in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
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