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Review Temsirolimus Safety Reports submitted to FDA

Total Temsirolimus reports: 108.
Temsirolimus FDA safety alerts: No.
Reported deaths: 17    Reported hospitalizations: 96.
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FDA Reported Temsirolimus Side Effects: thrombocytopenia, nausea, dyspnoea, rectal haemorrhage, pyrexia, haemoglobin decreased, respiratory failure, interstitial lung disease, diarrhoea, dehydration, upper gastrointestinal haemorrhage.
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Showing 1-100 of 108 Next >

Temsirolimus Side Effects Report #5382063-2
Physician from UNITED STATES reported TEMSIROLIMUS problem on July 03, 2007. Male patient, weighting 147.1 lb, was diagnosed with metastatic renal cell carcinoma, nausea and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: dehydration, dyspnoea. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with KYTRIL, ACIPHEX. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5383894-5
TEMSIROLIMUS problem was reported by a Physician from CANADA on July 04, 2007. Male patient, weighting 183.0 lb, was diagnosed with metastatic renal cell carcinoma and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, haematemesis, haemoglobin decreased, nausea, syncope, upper gastrointestinal haemorrhage. TEMSIROLIMUS dosage: 25 MG QWK (ONLY ONE DOSE WAS GIVEN). Patient was hospitalized. Patient died on 06/03/2007.

Temsirolimus Side Effects Report #5385602-0
Physician from UNITED STATES reported TEMSIROLIMUS problem on July 03, 2007. Male patient, weighting 180.8 lb, was diagnosed with renal cell carcinoma stage iv, hypersensitivity, oedema, reflux oesophagitis, nausea, flatulence, constipation, insomnia and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pathological fracture, rectal haemorrhage. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with OPTICRON, FUROSEMIDE, OMEPRAZOLE, COMPAZINE, DIMETICONE, DOCUSATE, TEMAZEPAM, POTASSIUM ACETATE. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5395413-8
TEMSIROLIMUS problem was reported by a Physician from UNITED STATES on July 13, 2007. Male patient, weighting 193.2 lb, was diagnosed with renal cancer metastatic, pain, chronic obstructive pulmonary disease, oedema, metastasis, hypertension and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, hyperkalaemia. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, SALBUTAMOL, SPIRONOLACTONE, ZOMETA, VICODIN, DECADRON, NORVASC. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5397424-5
Physician from UNITED STATES reported TEMSIROLIMUS problem on July 16, 2007. Male patient, weighting 147.1 lb, was diagnosed with metastatic renal cell carcinoma, nausea and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: dehydration, dyspnoea. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with KYTRIL, ACIPHEX. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5399199-2
TEMSIROLIMUS problem was reported by a Physician from CHINA on July 24, 2007. Male patient, weighting 174.2 lb, was diagnosed with mantle cell lymphoma, electrolyte imbalance, blood calcium decreased and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: angina pectoris. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with VITAMIN B6, POTASSIUM CHLORIDE, MUCOSOLVAN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM GLUCONATE, FAMOTIDINE. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5399805-2
Physician from CANADA reported TEMSIROLIMUS problem on July 18, 2007. Male patient, weighting 156.5 lb, was diagnosed with mantle cell lymphoma and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: pyrexia, sepsis. TEMSIROLIMUS dosage: unknown. Patient was hospitalized. Patient recovered.

Temsirolimus Side Effects Report #5400549-9
TEMSIROLIMUS problem was reported by a Physician from UNITED STATES on July 20, 2007. Male patient, weighting 156.1 lb, was diagnosed with mantle cell lymphoma, oedema peripheral, dry skin, chills, pain in extremity, headache and was treated with TEMSIROLIMUS. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, dyspnoea, renal failure acute. TEMSIROLIMUS dosage: unknown. During the same period patient was treated with HYDROCHLOROTHIAZIDE, EUCERIN CREME, IBUPROFEN, VICODIN. Patient was hospitalized. Patient recovered.

Showing 1-100 of 108 Next >


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dehydration, dyspnoea, cardiac arrest, haematemesis, haemoglobin decreased, nausea, syncope, upper gastrointestinal haemorrhage, , was diagnosed with metastatic renal cell carcinoma, nausea and was diagnosed with metastatic renal cell carcinoma and