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Afinitor (Everolimus) - Disability - Suspected Cause - Side Effect Reports

 
 



Index of reports > Disability (61)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Afinitor (Everolimus) disability. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 61   Next >>

Possible Afinitor side effects in female

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

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Thrombocytopenia, Acute Respiratory Failure, Hypovolaemia, Epistaxis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 89.2 kg (196.2 pounds)

Reactions: Abdominal Infection, Intestinal Perforation, Hepatic Infection, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Fluorouracil
    Dosage: 1200 mg/m2, qd
    Indication: Colorectal Cancer
    Start date: 2012-08-09
    End date: 2012-08-11

Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Colorectal Cancer
    Start date: 2012-08-09

Other drugs received by patient: Avastin; Diclofenac; Avastin; Fentanyl; Finasteride; Compazine; Emla; Acyclovir; Oxaliplatin; Ambien; Zofran; Ibuprofen; Baclofen



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 89.2 kg (196.2 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Colorectal Cancer
    Start date: 2012-08-09

Fluorouracil
    Dosage: 1200 mg/m2, qd
    Indication: Colorectal Cancer
    Start date: 2012-08-09
    End date: 2012-08-11

Other drugs received by patient: Oxaliplatin; Diclofenac; Acyclovir; Ambien; Finasteride; Avastin; Emla; Baclofen



Possible Afinitor side effects in female

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

Patient: female

Reactions: Metastases To Chest Wall, Neoplasm Malignant, Hypercapnia, Neoplasm Progression, Pleural Effusion, Pyrexia, Somnolence, Lethargy

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-07-29

Buspirone Hydrochloride
    Indication: Insomnia
    Start date: 2012-07-27
    End date: 2012-07-29

Other drugs received by patient: Amoxil; T4; Aromasin; Exelon; Dufalone



Possible Afinitor side effects in 79 year old female

Reported by a physician from Greece on 2012-08-01

Patient: 79 year old female

Reactions: Pyrexia, Somnolence, Lethargy

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Buspirone Hydrochloride
    Dosage: unk
    Indication: Insomnia
    Start date: 2012-07-27
    End date: 2012-07-29

Afinitor
    Dosage: 10 mg, daily
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-07-29

Other drugs received by patient: Aromasin; Amoxil; Dufalone; T4; Exelon



Possible Afinitor side effects in female

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

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Epistaxis, Hypovolaemia

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in male

Reported by a pharmacist from United States on 2012-07-10

Patient: male, weighing 77.2 kg (169.9 pounds)

Reactions: Tubulointerstitial Nephritis, Fanconi Syndrome, Renal Failure, Diarrhoea, Proteinuria, Renal Tubular Necrosis, Nephropathy, Lethargy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Inderal; Flomax; Lipid Modifying Agents; Lamivudine



Possible Afinitor side effects in male

Reported by a physician from Germany on 2012-07-03

Patient: male, weighing 51.0 kg (112.2 pounds)

Reactions: Mucosal Inflammation, Osteonecrosis of JAW, Exposed Bone in JAW, Swelling, Pain, Erythema

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg every 4 weeks
    Indication: Metastases To Bone
    Start date: 2007-11-01
    End date: 2010-06-01

Afinitor
    Dosage: 10 mg per day
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-11-01
    End date: 2011-03-01

Afinitor
    Dosage: 10 mg per day, with interupption every 3rd day
    Administration route: Oral
    Start date: 2011-04-01

Other drugs received by patient: Pantoprazole; Novalgin



Possible Afinitor side effects in female

Reported by a physician from Germany on 2012-07-03

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Mucosal Inflammation, Osteonecrosis of JAW, Pain, Swelling, Bone Disorder, Erythema

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, every 4 weeks
    Indication: Metastases To Bone
    Start date: 2007-11-01
    End date: 2010-06-01

Afinitor
    Dosage: 10 mg, per day with interruption every third day

Afinitor
    Dosage: 10 mg /day
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    End date: 2011-03-01

Other drugs received by patient: Pantoprazole; Novalgin



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-06-28

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Epistaxis, Hypovolaemia

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in male

Reported by a physician from Spain on 2012-06-28

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Anaemia, Asthenia, Blood Creatinine Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10mg
    Administration route: Oral
    Start date: 2010-08-02

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-03-29
    End date: 2010-07-19

Other drugs received by patient: Zarator ^parke Davis^



Possible Afinitor side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: female, weighing 58.3 kg (128.3 pounds)

Reactions: Blood Pressure Systolic Decreased, Weight Decreased, Gastrointestinal Haemorrhage, Neoplasm Progression, Neoplasm Malignant, Hypophagia, Oedema Peripheral, Abdominal Distension, Asthenia

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Aromasin
    Dosage: 25 mg, qd
    Indication: Breast Cancer
    Start date: 2012-01-26

Afinitor
    Start date: 2012-02-01



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-06-14

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Death, Dyspnoea, Interstitial Lung Disease

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Urso 250; Prednisolone; Piperacillin Sodium; Coldrin; Famotidine; Hachiazule



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female, weighing 61.4 kg (135.0 pounds)

Reactions: Renal Function Test Abnormal, Exposed Bone in JAW, JAW Fracture, Blood Count Abnormal, Glomerular Filtration Rate Increased, RED Cell Distribution Width Increased, Hypoaesthesia Oral, RED Blood Cell Count Decreased, Bone Disorder, Toothache, Mean Platelet Volume Decreased, Blood Creatinine Increased, Blood Glucose Increased, Neutrophil Count Increased, Haemoglobin Decreased, Mean Cell Volume Abnormal, Mean Cell Haemoglobin Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, monthly
    Indication: Metastases To Bone
    Start date: 2010-10-21
    End date: 2011-05-19

Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Renal Cell Carcinoma
    Start date: 2010-10-03

Other drugs received by patient: Multi-Vitamins; Ferrous Sulfate TAB; Metformin HCL; Chemotherapeutics; Folic Acid; Antidepressants; Glipizide; Ezetimibe / Samvastatin; Acetaminophen



Possible Afinitor side effects in male

Reported by a physician from Germany on 2012-06-01

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Pulmonary Embolism, Pneumothorax, Deep Vein Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Temsirolimus
    Dosage: unk
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-06-29
    End date: 2011-07-01

Afinitor
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-05-12
    End date: 2011-06-15

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2012-01-01

Afinitor
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 2011-09-22
    End date: 2012-02-20

Other drugs received by patient: Prednisolone



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-05-22

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Stomatitis, Neoplasm Malignant, Rectal Cancer, Pain in JAW, Blood Glucose Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Warfarin Sodium



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-18

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Pneumonia Primary Atypical, Pneumothorax, Pulmonary Embolism, Herpes Zoster, Deep Vein Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral

Temsirolimus
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-06-29
    End date: 2011-07-01

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-05-12
    End date: 2011-06-15

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-09-22
    End date: 2012-02-20

Other drugs received by patient: Prednisolone



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-05-02

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Neoplasm Malignant, Metastases To Spine, Neoplasm Progression, Spinal Cord Injury

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg daily
    Administration route: Oral
    Start date: 2011-02-01
    End date: 2011-03-10

Afinitor
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Renal Cell Carcinoma
    Start date: 2010-10-14
    End date: 2011-01-03

Other drugs received by patient: Oxycontin; Loxonin



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-04-24

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Hypovolaemia, Epistaxis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-04-23

Patient: male

Reactions: Metastases To Liver, Anaemia, Pyrexia, Renal Failure Chronic, Respiratory Distress, Hypokalaemia, Respiratory Failure, Interstitial Lung Disease, Surfactant Protein Increased, Cell Marker Increased, Blood Creatinine Increased, Cough

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Calcium Polystyrene Sulfonate
    Dosage: 3 df, unk
    Administration route: Oral

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Indication: Renal Cancer Recurrent
    Start date: 2010-09-02
    End date: 2010-09-08

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-01-06
    End date: 2011-03-09

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-04-14
    End date: 2011-07-25

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-08-05
    End date: 2010-09-01

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-08-30

Calcium Polystyrene Sulfonate
    Dosage: 3 df, unk
    Administration route: Oral
    Start date: 2009-10-14

Other drugs received by patient: Novorapid; Prednisolone; Prednisolone; Aldactone; Mucosolvan; Atelec; Rasilez (Aliskiren); Lasix; Novorapid; Cotrim; Prednisolone; Allopurinol; Depakene; Novorapid; Amlodipine; Irbesartan; Torsemide; Doxazosin Mesylate; Novorapid; Novorapid; Amlodipine; Amlodipine; Novorapid; Novorapid; Alendronate Sodium; Prednisolone; Carvedilol; Slow-K; Omeprazole; Novorapid; Novorapid; Magmitt



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-04-09

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Epistaxis, Hypovolaemia

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Trastuzumab; Paclitaxel



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-04-09

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Stomatitis, Vomiting, Nausea, Cardiac Failure, Eastern Cooperative Oncology Group Performance Status Worsened, Chronic Obstructive Pulmonary Disease, Decreased Appetite

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-08-11

Avastin
    Dosage: 10 mg/kg, qd
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-08-11

Avastin
    Dosage: 10 mg/kg, qd
    Start date: 2009-10-07
    End date: 2009-10-19

Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2009-10-07
    End date: 2009-10-18

Other drugs received by patient: Enoxaparin Sodium



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-04-02

Patient: male, weighing 59.0 kg (129.8 pounds)

Reactions: Multi-Organ Failure, Dysphagia, Renal Impairment, Dehydration

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Loxoprofen; Omeprazole; Bisoprolol Fumarate; Olmesartan Medoxomil; Torisel



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-03-29

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Stomatitis, Vomiting, Cardiac Failure, Nausea, Myocardial Ischaemia, Eastern Cooperative Oncology Group Performance Status Worsened, Chronic Obstructive Pulmonary Disease, Decreased Appetite

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-08-11

Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2009-10-07
    End date: 2009-10-18

Avastin
    Dosage: 10 mg/kg, qd
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-08-11

Avastin
    Dosage: 10 mg/kg, qd
    Start date: 2009-10-07
    End date: 2009-10-19

Other drugs received by patient: Enoxaparin Sodium



Possible Afinitor side effects in 62 year old male

Reported by a physician from Japan on 2012-03-13

Patient: 62 year old male

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg/day
    Administration route: Oral
    Start date: 2011-08-10

Bezatol
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-02-28
    End date: 2012-01-25

Lyrica
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    Start date: 2011-08-05
    End date: 2011-08-09

Afinitor
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Renal Cancer
    Start date: 2011-11-16
    End date: 2012-01-24

Afinitor
    Indication: Bone Neoplasm Malignant

Other drugs received by patient: Sutent



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-03-07

Patient: male

Reactions: Malaise, Dyspnoea, Fatigue, Dyspnoea Exertional, Oxygen Saturation, Cough, Pneumonitis

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Colace (Docusate Sodium) Capsule; Cymbalta; Combivent; Flomax; Proscar; Vitamin B12 (Cyanocobalamin) Tablet; Fentanyl; Lasix; Atorvastatin Calcium; Hydrocodone W / Paracetamol (Hydrocodone, Paracetamol); Senna (Senna, Senna Alexandrina) Tablet; Dexamethasone TAB; Symbicort



Possible Afinitor side effects in 81 year old male

Reported by a physician from United States on 2012-03-07

Patient: 81 year old male

Reactions: Weight Decreased, Fatigue, Pancytopenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Zometa



Possible Afinitor side effects in 81 year old male

Reported by a physician from United States on 2012-03-07

Patient: 81 year old male

Reactions: Weight Decreased, Fatigue, Pancytopenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Zometa



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-03-07

Patient: male

Reactions: Malaise, Dyspnoea, Fatigue, Dyspnoea Exertional, Oxygen Saturation, Pneumonitis, Cough

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Symbicort; Vitamin B12; Combivent; Cymbalta; Atorvastatin Calcium; Senna (Senna, Senna Alexandrina); Hydrocodone W / Paracetamol (Hydrocodone, Paracetamol); Colace (Docusate Sodium); Dexamethasone; Proscar; Fentanyl; Dexamethasone; Flomax; Flomax; Lasix



Possible Afinitor side effects in 62 year old male

Reported by a physician from Japan on 2012-03-05

Patient: 62 year old male

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Renal Cancer
    Start date: 2011-11-16
    End date: 2012-01-24

Afinitor
    Indication: Bone Neoplasm Malignant

Lyrica
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    Start date: 2011-08-05
    End date: 2011-08-09

Bezatol
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-02-28
    End date: 2012-01-25

Lyrica
    Dosage: 75 mg/day
    Administration route: Oral
    Start date: 2011-08-10



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