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Torisel (Temsirolimus) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Torisel (Temsirolimus) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (266)
Death (57)
Life Threatening Events (5)
Disability (7)

Reports by Reaction Type

Disease Progression (39)Death (25)Renal Cell Carcinoma (19)Dyspnoea (15)Decreased Appetite (14)Fatigue (12)Rash (12)Diarrhoea (12)Nausea (9)Neoplasm Malignant (9)Dehydration (9)Gastrointestinal Haemorrhage (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Torisel (Temsirolimus). For a complete list or a specific selection of reports, please use the links above.

Possible Torisel side effects in 43 year old male

Reported by a pharmacist from Australia on 2012-08-27

Patient: 43 year old male

Reactions: Renal Cancer Metastatic, Respiratory Distress, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in female

Reported by a physician from Colombia on 2012-08-22

Patient: female

Reactions: Malnutrition, Anaemia, Neoplasm, Disease Progression, Cachexia, Lung Disorder, Neoplasm Malignant, Blood Disorder, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Neoplasm Malignant, Renal Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 70 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Pneumonia, Thrombocytopenia, Groin Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel
    Dosage: 25 mg d1, d8 iv
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-30
    End date: 2012-08-06

Velcade
    Dosage: 3.6 mg d1, d8 iv
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-30
    End date: 2012-08-06



Possible Torisel side effects in 66 year old male

Reported by a physician from United States on 2012-08-21

Patient: 66 year old male

Reactions: Renal Cancer, Disease Progression

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in female

Reported by a pharmacist from Colombia on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 88 year old male

Reported by a physician from France on 2012-08-17

Patient: 88 year old male

Reactions: Haemorrhagic Stroke

Adverse event resulted in: death

Drug(s) suspected as cause:
Fragmin
    Dosage: unk

Torisel
    Dosage: unk
    Indication: Metastatic Carcinoma of THE Bladder
    Start date: 2012-01-03
    End date: 2012-03-20

Other drugs received by patient: Amlodipine Besylate; Ramipril; Aspirin; Acetaminophen; Helicidine; Chondrosulf



Possible Torisel side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 50 year old male

Reactions: Renal Cell Carcinoma, Disease Progression

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 74 year old male

Reported by a physician from France on 2012-08-15

Patient: 74 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Death, Depressed Level of Consciousness, Hydrocephalus

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Torisel
    Dosage: 25 mg, weekly
    Indication: Glioblastoma
    Start date: 2012-04-12
    End date: 2012-04-19

Torisel
    Dosage: 25 mg, weekly
    End date: 2012-05-10

Other drugs received by patient: Prednisolone; Clobazam; Escitalopram; Keppra; Rabeprazole Sodium



Possible Torisel side effects in 54 year old male

Reported by a physician from Germany on 2012-08-14

Patient: 54 year old male, weighing 114.0 kg (250.8 pounds)

Reactions: Lipids Abnormal, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel

Other drugs received by patient: Metoclopramide; Clemastine Fumarate; Dexamethasone; Hydrochlorothiazide; Enalapril; Metformin; Voltaren; Metoprolol; Pantoprazole; Corvo; Colchicine



Possible Torisel side effects in

Reported by a lawyer from United States on 2012-08-14

Patient:

Reactions: Renal Cancer, Disease Progression, Pneumonitis, Pulmonary Fibrosis

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 88 year old male

Reported by a physician from France on 2012-08-10

Patient: 88 year old male

Reactions: Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Fragmin
    Dosage: unk

Torisel
    Dosage: unk
    Indication: Metastatic Carcinoma of THE Bladder
    Start date: 2012-01-03
    End date: 2012-03-20

Other drugs received by patient: Ramipril; Acetaminophen; Aspirin; Amlodipine Besylate; Chondrosulf; Helicidine



Possible Torisel side effects in 74 year old male

Reported by a physician from France on 2012-08-10

Patient: 74 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Death, Depressed Level of Consciousness, Hydrocephalus

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Torisel
    Dosage: 25 mg, weekly
    End date: 2012-05-10

Torisel
    Dosage: 25 mg, weekly
    Indication: Glioblastoma
    Start date: 2012-04-12
    End date: 2012-04-19

Other drugs received by patient: Prednisolone; Keppra; Clobazam; Rabeprazole Sodium; Escitalopram



Possible Torisel side effects in 53 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 53 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Gastrointestinal Haemorrhage, Stomatitis, Fungal Infection, Interstitial Lung Disease, Haemorrhagic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel
    Dosage: 25 mg, weekly
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2012-05-08
    End date: 2012-07-10

Torisel
    Indication: Metastases To Liver

Torisel
    Indication: Metastases To Lung

Other drugs received by patient: Naproxen; Celebrex; Lansoprazole; Celebrex; Feburic



Possible Torisel side effects in 71 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 71 year old male, weighing 56.4 kg (124.1 pounds)

Reactions: Renal Cell Carcinoma, Pneumonia, Brain Oedema, Disease Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Torisel
    Dosage: 25 mg, weekly
    Indication: Renal Cell Carcinoma
    Start date: 2011-05-16
    End date: 2011-05-23

Torisel
    Dosage: 25 mg, unk
    Start date: 2011-07-06
    End date: 2011-07-06

Torisel
    Dosage: 25 mg, unk
    Start date: 2011-07-13
    End date: 2011-07-13

Torisel
    Dosage: 25 mg, unk
    Start date: 2011-06-28
    End date: 2011-06-28

Other drugs received by patient: Loxonin; Adenosine; Lendormin D; Tamsulosin HCL; Amaryl; Vitamin B12; Norvasc; Selbex; Chlor-Trimeton; Magmitt; Carnaculin; Mucosta



Possible Torisel side effects in 85 year old male

Reported by a physician from United States on 2012-08-08

Patient: 85 year old male

Reactions: Fluid Retention

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 68 year old male

Reported by a physician from Japan on 2012-08-08

Patient: 68 year old male

Reactions: Atrioventricular Block Complete

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 80 year old male

Reported by a physician from Switzerland on 2012-08-07

Patient: 80 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Pneumonia, Renal Failure, Sepsis, Lower Limb Fracture, Fall

Adverse event resulted in: death

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 54 year old male

Reported by a physician from Germany on 2012-08-07

Patient: 54 year old male, weighing 114.0 kg (250.8 pounds)

Reactions: Lipids Abnormal, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel

Other drugs received by patient: Metformin; Hydrochlorothiazide; Clemastine Fumarate; Enalapril; Pantoprazole; Corvo; Metoclopramide; Dexamethasone; Metoprolol; Voltaren; Colchicine



Possible Torisel side effects in 64 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 64 year old male

Reactions: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in male

Reported by a physician from Germany on 2012-08-06

Patient: male

Reactions: Lymphopenia, Blood Triglycerides Increased, Blood Cholesterol Increased

Drug(s) suspected as cause:
Rituximab
    Dosage: 787.50 mg, unknown/d
    Indication: Lymphoma
    Start date: 2012-01-25

Torisel
    Dosage: 75 mg, unknown/d
    Indication: Lymphoma
    Start date: 2012-01-26

Treanda
    Dosage: 189 mg, unknown /d
    Indication: Lymphoma
    Start date: 2012-01-25



Possible Torisel side effects in 66 year old male

Reported by a physician from Germany on 2012-08-03

Patient: 66 year old male

Reactions: Renal Cell Carcinoma, Cerebral Disorder, Optic Disc Haemorrhage, Paraesthesia, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 75 year old male

Reported by a physician from Germany on 2012-08-03

Patient: 75 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Ejection Fraction Decreased

Drug(s) suspected as cause:
Cytarabine
    Dosage: 187 mg, 1x/day (100 mg/m2)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-28
    End date: 2012-07-04

Daunorubicin HCL
    Dosage: 122.20 mg, 1x/day (60 mg/m2)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-30
    End date: 2012-07-02

Torisel
    Dosage: 12.5 mg, cyclic (on days 1 and 8)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-27
    End date: 2012-06-27

Torisel
    Dosage: 12.5 mg, cyclic (on days 1 and 8)
    Start date: 2012-07-05
    End date: 2012-07-05

Other drugs received by patient: Ambisome; Piperacillin and Tazobactam; Ambisome; Piperacillin and Tazobactam



Possible Torisel side effects in male

Reported by a physician from Germany on 2012-08-02

Patient: male

Reactions: Deafness

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 45 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 45 year old female

Reactions: Gastric Haemorrhage

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 77 year old male

Reported by a physician from Greece on 2012-07-31

Patient: 77 year old male

Reactions: Aphthous Stomatitis, Oral Pain, Tongue Ulceration

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in

Reported by a physician from United States on 2012-07-31

Patient:

Reactions: Anaemia

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 63 year old male

Reported by a pharmacist from Japan on 2012-07-31

Patient: 63 year old male

Reactions: Renal Cell Carcinoma, Ileus, Disease Progression

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 53 year old female

Reported by a physician from Germany on 2012-07-30

Patient: 53 year old female, weighing 56.4 kg (124.1 pounds)

Reactions: Epilepsy, Metastases To Central Nervous System

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel



Possible Torisel side effects in 54 year old male

Reported by a physician from Germany on 2012-07-30

Patient: 54 year old male, weighing 114.0 kg (250.8 pounds)

Reactions: Lipids Abnormal, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Torisel

Other drugs received by patient: Metoprolol; Enalapril; Pantoprazole; Corvo; Metoclopramide; Clemastine Fumarate; Colchicine; Metformin; Hydrochlorothiazide; Dexamethasone; Voltaren

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