Drug information for TORISEL

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION; INTRAVENOUS	25MG/ML (25MG/ML)	Prescription	(Reference Drug)	TEMSIROLIMUS	temsirolimus	WYETH PHARMS INC	22088 2011-06-27 Letter 2011-06-27 Letter 2011-06-27 Letter 2011-06-27 Letter 2011-06-27 Letter 2011-06-27 Letter 2011-06-16 Label 2011-06-16 Label 2011-06-16 Label 2011-06-16 Label 2011-06-16 Label 2011-06-16 Label 2010-07-14 Letter 2010-07-12 Label 2010-04-29 Letter 2010-04-28 Label 2007-11-19 Label 2007-11-19 Letter 2007-07-30 Review 2007-06-04 Label 2007-06-04 Letter

Drug Adverse Effects information for TORISEL

Role code	Indications	Reaction	# Reports
PS	ANTACID THERAPY	DISEASE PROGRESSION	1
PS	ANTACID THERAPY	RENAL CELL CARCINOMA	1
PS	ANXIETY	ARTHRALGIA	2
PS	ANXIETY	CHEST DISCOMFORT	1
PS	ANXIETY	JOINT SWELLING	2
PS	ANXIETY	PYREXIA	2
PS	ANXIETY	RASH	2
PS	ANXIETY	RASH MACULAR	1
PS	BENIGN PROSTATIC HYPERPLASIA	FATIGUE	1
PS	BENIGN PROSTATIC HYPERPLASIA	HYPOTENSION	1
PS	BLOOD CHOLESTEROL INCREASED	BLOOD GLUCOSE INCREASED	1
PS	BLOOD CHOLESTEROL INCREASED	FATIGUE	2
PS	BLOOD CHOLESTEROL INCREASED	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	BLOOD CHOLESTEROL INCREASED	HYPOTENSION	2
PS	BREAST CANCER METASTATIC	ARTHRALGIA	4
PS	BREAST CANCER METASTATIC	CHEST DISCOMFORT	2
PS	BREAST CANCER METASTATIC	JOINT SWELLING	4
PS	BREAST CANCER METASTATIC	PYREXIA	4
PS	BREAST CANCER METASTATIC	RASH	4
PS	BREAST CANCER METASTATIC	RASH MACULAR	2
PS	CARDIAC FAILURE	BLOOD GLUCOSE INCREASED	1
PS	CARDIAC FAILURE	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	CONVULSION	FATIGUE	1
PS	CONVULSION	HYPOTENSION	1
PS	CORONARY ARTERY DISEASE	FATIGUE	1
PS	CORONARY ARTERY DISEASE	HYPOTENSION	1
PS	DIABETES MELLITUS	BLOOD GLUCOSE INCREASED	2
PS	DIABETES MELLITUS	GENERAL PHYSICAL HEALTH DETERIORATION	2
PS	DIARRHOEA	ARTHRALGIA	2
PS	DIARRHOEA	CHEST DISCOMFORT	1
PS	DIARRHOEA	JOINT SWELLING	2
PS	DIARRHOEA	PYREXIA	2
PS	DIARRHOEA	RASH	2
PS	DIARRHOEA	RASH MACULAR	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	ARTHRALGIA	6
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CHEST DISCOMFORT	3
PS	GASTROOESOPHAGEAL REFLUX DISEASE	FATIGUE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	HYPOTENSION	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	JOINT SWELLING	6
PS	GASTROOESOPHAGEAL REFLUX DISEASE	PYREXIA	6
PS	GASTROOESOPHAGEAL REFLUX DISEASE	RASH	6
PS	GASTROOESOPHAGEAL REFLUX DISEASE	RASH MACULAR	3
PS	HYPERCALCAEMIA	DISEASE PROGRESSION	2
PS	HYPERCALCAEMIA	DISSEMINATED INTRAVASCULAR COAGULATION	1
PS	HYPERCALCAEMIA	METASTATIC RENAL CELL CARCINOMA	1
PS	HYPERCALCAEMIA	RENAL CELL CARCINOMA	1
PS	HYPERCALCAEMIA	RENAL FAILURE	1
PS	HYPERCALCAEMIA	SALMONELLA BACTERAEMIA	1
PS	HYPERTENSION	DISEASE PROGRESSION	6
PS	HYPERTENSION	LUNG INFILTRATION	6
PS	HYPERTENSION	PRURITUS	6
PS	HYPERTENSION	RASH MACULAR	6
PS	HYPERTENSION	RENAL CELL CARCINOMA	6
PS	HYPOTHYROIDISM	ARTHRALGIA	2
PS	HYPOTHYROIDISM	CHEST DISCOMFORT	1
PS	HYPOTHYROIDISM	JOINT SWELLING	2
PS	HYPOTHYROIDISM	PYREXIA	2
PS	HYPOTHYROIDISM	RASH	2
PS	HYPOTHYROIDISM	RASH MACULAR	1
PS	MANTLE CELL LYMPHOMA	CEREBRAL HAEMORRHAGE	1
PS	MANTLE CELL LYMPHOMA	DISEASE RECURRENCE	1
PS	MANTLE CELL LYMPHOMA	MANTLE CELL LYMPHOMA	1
PS	MANTLE CELL LYMPHOMA	MYELODYSPLASTIC SYNDROME	3
PS	MANTLE CELL LYMPHOMA	NEOPLASM MALIGNANT	3
PS	MANTLE CELL LYMPHOMA	ROAD TRAFFIC ACCIDENT	1
PS	MANTLE CELL LYMPHOMA RECURRENT	PULMONARY TOXICITY	1
PS	METASTASES TO BONE	PNEUMOCYSTIS JIROVECI PNEUMONIA	1
PS	METASTASES TO BONE	PYREXIA	1
PS	METASTATIC RENAL CELL CARCINOMA	BONE MARROW FAILURE	1
PS	METASTATIC RENAL CELL CARCINOMA	CARDIOVASCULAR DISORDER	1
PS	METASTATIC RENAL CELL CARCINOMA	DEATH	2
PS	METASTATIC RENAL CELL CARCINOMA	DIARRHOEA	1
PS	METASTATIC RENAL CELL CARCINOMA	DISEASE PROGRESSION	1
PS	METASTATIC RENAL CELL CARCINOMA	FATIGUE	1
PS	METASTATIC RENAL CELL CARCINOMA	HAEMORRHAGE	2
PS	METASTATIC RENAL CELL CARCINOMA	LUNG INFILTRATION	1
PS	METASTATIC RENAL CELL CARCINOMA	METASTATIC RENAL CELL CARCINOMA	1
PS	METASTATIC RENAL CELL CARCINOMA	MYOCARDIAL INFARCTION	2
PS	METASTATIC RENAL CELL CARCINOMA	PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	3
PS	METASTATIC RENAL CELL CARCINOMA	THROMBOCYTOPENIA	1
PS	NAUSEA	DISEASE PROGRESSION	1
PS	NAUSEA	RENAL CELL CARCINOMA	1
PS	OVARIAN CANCER	DEATH	1
PS	OVARIAN CANCER	DISEASE PROGRESSION	1
PS	OVARIAN CANCER	OVARIAN CANCER	1
PS	PAIN	DISEASE PROGRESSION	1
PS	PAIN	RENAL CELL CARCINOMA	1
PS	PARKINSON'S DISEASE	DISEASE PROGRESSION	1
PS	PARKINSON'S DISEASE	DISSEMINATED INTRAVASCULAR COAGULATION	1
PS	PARKINSON'S DISEASE	METASTATIC RENAL CELL CARCINOMA	1
PS	PARKINSON'S DISEASE	RENAL FAILURE	1
PS	PARKINSON'S DISEASE	SALMONELLA BACTERAEMIA	1
PS	PROSTATE CANCER	COUGH	1
PS	PROSTATE CANCER	DECREASED APPETITE	1
PS	PROSTATE CANCER	DYSPNOEA	1
PS	PROSTATE CANCER	NEOPLASM MALIGNANT	1
PS	PROSTATE CANCER	PNEUMONIA	1
PS	PROSTATE CANCER	PROSTATE CANCER	1
PS	PROSTATE CANCER	SPINAL CORD COMPRESSION	1
PS	RENAL CANCER	LUNG INFILTRATION	1
PS	RENAL CANCER	PNEUMOCYSTIS JIROVECI PNEUMONIA	1
PS	RENAL CANCER	PYREXIA	1
PS	RENAL CANCER METASTATIC	CYANOSIS	1
PS	RENAL CANCER METASTATIC	DYSPNOEA	1
PS	RENAL CANCER METASTATIC	FEELING HOT	1
PS	RENAL CANCER METASTATIC	HAEMATEMESIS	1
PS	RENAL CANCER METASTATIC	HYPERSENSITIVITY	1
PS	RENAL CANCER METASTATIC	HYPERTENSION	1
PS	RENAL CANCER METASTATIC	TACHYCARDIA	1
PS	RENAL CANCER METASTATIC	VERTIGO	1
PS	RENAL CELL CARCINOMA	BLOOD CREATININE INCREASED	1
PS	RENAL CELL CARCINOMA	BLOOD GLUCOSE INCREASED	1
PS	RENAL CELL CARCINOMA	DEATH	2
PS	RENAL CELL CARCINOMA	DEHYDRATION	1
PS	RENAL CELL CARCINOMA	DIARRHOEA	1
PS	RENAL CELL CARCINOMA	DISEASE PROGRESSION	5
PS	RENAL CELL CARCINOMA	DISSEMINATED INTRAVASCULAR COAGULATION	1
PS	RENAL CELL CARCINOMA	FATIGUE	2
PS	RENAL CELL CARCINOMA	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	RENAL CELL CARCINOMA	HYPOTENSION	1
PS	RENAL CELL CARCINOMA	LUNG INFILTRATION	2
PS	RENAL CELL CARCINOMA	METASTATIC RENAL CELL CARCINOMA	1
PS	RENAL CELL CARCINOMA	NAUSEA	1
PS	RENAL CELL CARCINOMA	PRURITUS	2
PS	RENAL CELL CARCINOMA	RASH MACULAR	2
PS	RENAL CELL CARCINOMA	RENAL CELL CARCINOMA	4
PS	RENAL CELL CARCINOMA	RENAL FAILURE	1
PS	RENAL CELL CARCINOMA	RENAL FAILURE ACUTE	1
PS	RENAL CELL CARCINOMA	SALIVARY HYPERSECRETION	2
PS	RENAL CELL CARCINOMA	SALMONELLA BACTERAEMIA	1
PS	RENAL CELL CARCINOMA	STEVENS-JOHNSON SYNDROME	1
PS	RENAL CELL CARCINOMA	VOMITING	1
PS	SUPPLEMENTATION THERAPY	ARTHRALGIA	4
PS	SUPPLEMENTATION THERAPY	CHEST DISCOMFORT	2
PS	SUPPLEMENTATION THERAPY	JOINT SWELLING	4
PS	SUPPLEMENTATION THERAPY	PYREXIA	4
PS	SUPPLEMENTATION THERAPY	RASH	4
PS	SUPPLEMENTATION THERAPY	RASH MACULAR	2
PS	THYROID CANCER	DEATH	2
PS	THYROID CANCER	DECREASED APPETITE	4
PS	THYROID CANCER	DEEP VEIN THROMBOSIS	2
PS	THYROID CANCER	DEHYDRATION	4
PS	THYROID CANCER	FATIGUE	4
PS	THYROID CANCER	HAEMOPTYSIS	4
PS	THYROID CANCER	PAIN	4
PS	THYROID CANCER	PNEUMONITIS	2
PS	THYROID CANCER	PULMONARY HAEMORRHAGE	2
SS	MANTLE CELL LYMPHOMA	MYELODYSPLASTIC SYNDROME	3
SS	METASTASES TO BONE	PNEUMOCYSTIS JIROVECI PNEUMONIA	1
SS	METASTASES TO BONE	PYREXIA	1
SS	NEOPLASM	HYPOPHOSPHATAEMIA	2
SS	NEOPLASM	NEUTROPHIL COUNT DECREASED	2
SS	NEOPLASM	PLATELET COUNT DECREASED	2
SS	NEOPLASM	WHITE BLOOD CELL COUNT DECREASED	2
SS	NEOPLASM MALIGNANT	VENA CAVA THROMBOSIS	2
SS	RENAL CANCER	PNEUMOCYSTIS JIROVECI PNEUMONIA	1
SS	RENAL CANCER	PYREXIA	1
C	BENIGN PROSTATIC HYPERPLASIA	BLOOD GLUCOSE INCREASED	1
C	BENIGN PROSTATIC HYPERPLASIA	BLOOD LACTATE DEHYDROGENASE INCREASED	1
C	BENIGN PROSTATIC HYPERPLASIA	CYANOSIS	1
C	BENIGN PROSTATIC HYPERPLASIA	INTERSTITIAL LUNG DISEASE	1
C	BENIGN PROSTATIC HYPERPLASIA	PRODUCTIVE COUGH	1
C	BENIGN PROSTATIC HYPERPLASIA	RESPIRATORY DISTRESS	1
C	BONE DISORDER	ANAEMIA	1
C	BONE DISORDER	ANAEMIA OF MALIGNANT DISEASE	1
C	BONE DISORDER	ASTHENIA	1
C	BONE DISORDER	DEATH	2
C	BONE DISORDER	DECREASED APPETITE	1
C	BONE DISORDER	GENERAL PHYSICAL HEALTH DETERIORATION	2
C	BONE DISORDER	INTRA-ABDOMINAL PRESSURE INCREASED	1
C	BONE DISORDER	NEOPLASM MALIGNANT	1
C	BONE DISORDER	NEOPLASM PROGRESSION	1
C	CHEMOTHERAPY	ANAEMIA	1
C	CHEMOTHERAPY	ANAEMIA OF MALIGNANT DISEASE	1
C	CHEMOTHERAPY	ASTHENIA	1
C	CHEMOTHERAPY	DECREASED APPETITE	1
C	CHEMOTHERAPY	GENERAL PHYSICAL HEALTH DETERIORATION	1
C	CHEMOTHERAPY	INTRA-ABDOMINAL PRESSURE INCREASED	1
C	CHEMOTHERAPY	NEOPLASM MALIGNANT	1
C	CHEMOTHERAPY	NEOPLASM PROGRESSION	1
C	GASTRIC ULCER	BLOOD GLUCOSE INCREASED	1
C	GASTRIC ULCER	BLOOD LACTATE DEHYDROGENASE INCREASED	1
C	GASTRIC ULCER	CYANOSIS	1
C	GASTRIC ULCER	INTERSTITIAL LUNG DISEASE	1
C	GASTRIC ULCER	PRODUCTIVE COUGH	1
C	GASTRIC ULCER	RESPIRATORY DISTRESS	1
C	HYPERTENSION	BLOOD GLUCOSE INCREASED	2
C	HYPERTENSION	BLOOD LACTATE DEHYDROGENASE INCREASED	2
C	HYPERTENSION	CYANOSIS	2
C	HYPERTENSION	INTERSTITIAL LUNG DISEASE	2
C	HYPERTENSION	PRODUCTIVE COUGH	2
C	HYPERTENSION	RESPIRATORY DISTRESS	2
C	HYPERURICAEMIA	BLOOD GLUCOSE INCREASED	1
C	HYPERURICAEMIA	BLOOD LACTATE DEHYDROGENASE INCREASED	1
C	HYPERURICAEMIA	CYANOSIS	1
C	HYPERURICAEMIA	INTERSTITIAL LUNG DISEASE	1
C	HYPERURICAEMIA	PRODUCTIVE COUGH	1
C	HYPERURICAEMIA	RESPIRATORY DISTRESS	1
C	METASTATIC RENAL CELL CARCINOMA	BLOOD GLUCOSE INCREASED	3
C	METASTATIC RENAL CELL CARCINOMA	BLOOD LACTATE DEHYDROGENASE INCREASED	3
C	METASTATIC RENAL CELL CARCINOMA	CYANOSIS	3
C	METASTATIC RENAL CELL CARCINOMA	GAMMA-GLUTAMYLTRANSFERASE INCREASED	22
C	METASTATIC RENAL CELL CARCINOMA	INTERSTITIAL LUNG DISEASE	3
C	METASTATIC RENAL CELL CARCINOMA	METASTASES TO LUNG	22
C	METASTATIC RENAL CELL CARCINOMA	NEOPLASM MALIGNANT	22
C	METASTATIC RENAL CELL CARCINOMA	NEOPLASM PROGRESSION	22
C	METASTATIC RENAL CELL CARCINOMA	PRODUCTIVE COUGH	3
C	METASTATIC RENAL CELL CARCINOMA	RENAL HAEMORRHAGE	22
C	METASTATIC RENAL CELL CARCINOMA	RESPIRATORY DISTRESS	3

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