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

 
 



Index of reports > Cases with Malaise (105)

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

 Reports 1 - 30 of 105   Next >>

Possible Afinitor side effects in male

Reported by a physician from Canada on 2012-08-23

Patient: male, weighing 113.4 kg (249.4 pounds)

Reactions: Blood Cholesterol Abnormal, Diabetes Mellitus, Weight Increased, Abnormal Dreams, Malaise, Fatigue, Thinking Abnormal, Musculoskeletal Stiffness, Muscle Spasms, Blood Pressure Increased, Blood Cortisol Abnormal, Hormone Level Abnormal, Cushing's Syndrome, Psychotic Disorder, Blood Potassium Decreased, Neoplasm Malignant, Swelling, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10mg every day
    Administration route: Oral
    Indication: Ectopic Acth Syndrome
    Start date: 2011-05-01

Sandostatin LAR
    Dosage: 30 mg every 2 weeks

Sandostatin LAR
    Dosage: 30 mg, qmo
    Indication: Ectopic Acth Syndrome
    Start date: 2010-11-30



Possible Afinitor side effects in female

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

Patient: female

Reactions: Injection Site Mass, Contusion, Pneumonia, Nausea, Pain, Fall, Pallor, Myalgia, Malaise, Fatigue, Diarrhoea, Blood Potassium Decreased, Decreased Appetite, Lethargy

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, unk
    Administration route: Oral

Afinitor
    Dosage: 10 mg, every day
    Administration route: Oral
    Indication: Carcinoid Tumour

Sandostatin LAR
    Dosage: 80 mg, every four weeks

Sandostatin LAR
    Dosage: 80 mg, qmo
    Indication: Carcinoid Tumour
    Start date: 2008-04-28

Sandostatin LAR
    Dosage: 80 mg, once in a month
    Start date: 2008-04-28



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-21

Patient: female

Reactions: Confusional State, Dyspnoea, Neoplasm Progression, Blood Glucose Decreased, Malaise, Fatigue, Neoplasm Malignant, Brain Oedema, Diabetic Coma, Hypersomnia, Lethargy, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Lipitor; Oral Antidiabetics; Antiobesity Preparations, Excl Diet Products; Beta Blocking Agents; Steroids NOS



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-03

Patient: female

Reactions: Dyspnoea, Blood Glucose Decreased, Malaise, Diabetic Coma, Brain Oedema, Lethargy, Hypersomnia, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

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

Patient: male

Reactions: Respiratory Disorder, Dyspnoea, Blood Lactate Dehydrogenase Increased, Neoplasm Progression, Pyrexia, Appetite Disorder, Fatigue, Malaise, Neoplasm Malignant, Interstitial Lung Disease, C-Reactive Protein Increased, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Allopurinol; Hachiazule



Possible Afinitor side effects in female

Reported by a physician from Canada on 2012-07-24

Patient: female

Reactions: Injection Site Mass, Contusion, Pneumonia, Nausea, Pain, Pallor, Fall, Myalgia, Fatigue, Malaise, Diarrhoea, Blood Potassium Decreased, Lethargy

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, every day
    Administration route: Oral
    Indication: Carcinoid Tumour

Sandostatin LAR
    Dosage: 80 mg, qmo
    Indication: Carcinoid Tumour
    Start date: 2008-04-28

Sandostatin LAR
    Dosage: 80 mg, every four weeks



Possible Afinitor side effects in male

Reported by a physician from Canada on 2012-07-18

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Weight Increased, Death, Malaise, Fatigue, Pain, Underdose, Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Small Intestine Carcinoma
    Start date: 2011-08-04
    End date: 2011-12-02

Sandostatin LAR
    Dosage: 40mg every 3 weeks
    Indication: Small Intestine Carcinoma
    Start date: 2009-03-02



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from Canada on 2012-07-17

Patient: male

Reactions: Renal Function Test Abnormal, Malaise, Neoplasm Malignant, Metastases To Large Intestine, Neoplasm Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Neuroendocrine Tumour
    Start date: 2011-06-02
    End date: 2011-09-16

Sandostatin LAR
    Dosage: 30 mg every 4 weeks
    Indication: Neuroendocrine Tumour
    Start date: 2011-03-12



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from Canada on 2012-06-29

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Contusion, Injection Site Pain, General Physical Health Deterioration, Fall, Polymyositis, Road Traffic Accident, Malaise, Diarrhoea, Gait Disturbance, Feeling Abnormal, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    End date: 2012-01-01

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2011-07-12
    End date: 2011-10-10

Sandostatin LAR
    Dosage: 40 mg, qmo

Sandostatin LAR
    Dosage: 30 mg, qmo
    Indication: Pancreatic Neuroendocrine Tumour Metastatic
    Start date: 2011-08-31



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-28

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Weight Increased, Malaise, Fatigue, Pain, Underdose, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Small Intestine Carcinoma
    Start date: 2011-08-04

Sandostatin LAR
    Dosage: 40mg every 3 weeks
    Indication: Small Intestine Carcinoma
    Start date: 2009-03-02



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-06-26

Patient: female

Reactions: Injection Site Mass, Contusion, Pneumonia, Nausea, Pain, Fall, Pallor, Myalgia, Malaise, Fatigue, Blood Potassium Decreased, Diarrhoea

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, every day
    Administration route: Oral
    Indication: Carcinoid Tumour

Sandostatin LAR
    Dosage: 80 mg, qmo
    Indication: Carcinoid Tumour
    Start date: 2008-04-28

Sandostatin LAR
    Dosage: 80 mg, every four weeks



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-06-22

Patient: female

Reactions: Dyspnoea, Malaise, Somnolence, Lethargy

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from Canada on 2012-06-21

Patient: male

Reactions: Malaise, Viral Infection, Renal Failure, Lung Disorder, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2012-03-01

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-10-10



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from Canada on 2012-06-21

Patient: male

Reactions: Death, Movement Disorder, Vomiting, Malaise, Fatigue, Diabetes Mellitus, Hypophagia, Abdominal Pain Upper

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 05 mg every day
    Administration route: Oral
    Indication: Neuroendocrine Tumour
    Start date: 2012-01-26

Sandostatin LAR
    Dosage: 20 mg, every 4 weeks
    Indication: Neuroendocrine Tumour



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-06-21

Patient: male

Reactions: Vomiting, Malaise, Immunodeficiency, Convulsion, Influenza Like Illness

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Risperdal; Lamictal



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-20

Patient: male

Reactions: Contusion, Blood Creatine Phosphokinase Increased, General Physical Health Deterioration, Injection Site Pain, Fall, Malaise, Road Traffic Accident, Polymyositis, Diarrhoea, Feeling Abnormal, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2011-07-12
    End date: 2011-10-10

Sandostatin LAR
    Dosage: 40 mg, qmo
    Indication: Pancreatic Neuroendocrine Tumour Metastatic
    Start date: 2011-08-31

Sandostatin LAR
    Dosage: 40 mg, qmo



Possible Afinitor side effects in male

Reported by a physician from Germany on 2012-06-19

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Right Ventricular Failure, Pneumonia, Dyspnoea, Diabetes Mellitus, Chills, Anaemia, Pulmonary Embolism, Cardiomegaly, Cardiac Disorder, Fatigue, Renal Impairment, Malaise, Gamma-Glutamyltransferase Increased, Pleural Effusion, Pneumonitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Marcumar; Propranolol HCL; Ramipril; Abnobaviscum; Omeprazole; ACE Inhibitors; Humalog; Levemir; Allobeta; Diclac



Possible Afinitor side effects in 67 year old male

Reported by a physician from Japan on 2012-06-15

Patient: 67 year old male

Reactions: Malaise, Cardio-Respiratory Arrest, Neoplasm Malignant, Neoplasm Progression, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-07-12
    End date: 2010-08-30

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2010-11-01
    End date: 2010-11-12

Other drugs received by patient: Interferon Alfa; Oxycontin; Allopurinol; Levothyroxine Sodium; Sunitinib Malate; Prochlorperazine; Levothyroxine Sodium; Allopurinol; Urso 250; Etodolac; Magnesium Oxide; Teceleukin; Betamethasone



Possible Afinitor side effects in male

Reported by a physician from France on 2012-06-11

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Dyslipidaemia, Haemorrhage, Tendon Rupture, Neoplasm Progression, Fall, Periarthritis, Malaise, Oedema Peripheral, Rotator Cuff Syndrome, Cough, Back Pain, Scapula Fracture, Vomiting, Blood Pressure Systolic Increased, Rash, Joint Injury, Diarrhoea, Neoplasm Malignant

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Renal Cancer
    Start date: 2011-12-01
    End date: 2011-12-27

Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2012-01-16

Enalapril Maleate
    Dosage: 10 mg, daily (in the morning)

Enalapril Maleate

Other drugs received by patient: Cetirizine; Sutent



Possible Afinitor side effects in male

Reported by a physician from France on 2012-06-11

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Dyslipidaemia, Tendon Rupture, Haemorrhage, Neoplasm Progression, Fall, Periarthritis, Malaise, Oedema Peripheral, Rotator Cuff Syndrome, Cough, Scapula Fracture, Back Pain, Vomiting, Blood Pressure Systolic Increased, Rash, Joint Injury, Neoplasm Malignant, Diarrhoea

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Renal Cancer
    Start date: 2011-12-01
    End date: 2011-12-27

Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2012-01-16

Enalapril Maleate

Enalapril Maleate
    Dosage: 10 mg, daily (in the morning)

Other drugs received by patient: Sutent; Cetirizine



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: female

Reactions: Scab, Folliculitis, Pyrexia, Erythema, Rash Pruritic, Malaise, Upper Respiratory Tract Infection, Skin Odour Abnormal, Staring, Lethargy, Scratch, Rash, DRY Skin, Convulsion, Sinus Headache, Hand-Foot-and-Mouth Disease, Escherichia Infection, Gastroenteritis Viral, Influenza Like Illness, Infantile Spasms

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Keppra; Vimpat; Rapamune; Diastat; Vimpat



Possible Afinitor side effects in male

Reported by a physician from Canada on 2012-05-30

Patient: male

Reactions: Movement Disorder, Fatigue, Malaise, Vomiting, Diabetes Mellitus, Hypophagia, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 05 mg every day
    Administration route: Oral
    Indication: Neuroendocrine Tumour
    Start date: 2012-01-26

Sandostatin LAR
    Dosage: 20 mg, every 4 weeks
    Indication: Neuroendocrine Tumour



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-30

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Weight Increased, Fatigue, Malaise, Pain, Underdose, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Small Intestine Carcinoma
    Start date: 2011-08-04

Sandostatin LAR
    Dosage: 40mg every 3 weeks
    Indication: Small Intestine Carcinoma
    Start date: 2009-03-02



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from Canada on 2012-05-28

Patient: male

Reactions: Pneumonia, Nasopharyngitis, Neoplasm Progression, Blood Calcium Increased, Pulmonary Embolism, Malaise, Blood Phosphorus Decreased, Neoplasm Malignant, Heart Rate Increased, Dehydration, Carbon Dioxide Increased, Anion GAP Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg,
    Administration route: Oral
    Indication: Thymic Cancer Metastatic
    Start date: 2010-12-06

Aredia
    Indication: Thymic Cancer Metastatic

Sandostatin
    Dosage: 30 mg, once in 4 weeks
    Indication: Thymic Cancer Metastatic
    Start date: 2008-12-27

Zometa
    Dosage: 4 mg every 3 weeks
    Indication: Thymic Cancer Metastatic
    Start date: 2010-05-26
    End date: 2012-04-27



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-28

Patient: male

Reactions: Death, Malaise

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-25

Patient: male

Reactions: Weight Decreased, Back Pain, Vomiting, Neoplasm Progression, Abdominal Pain Upper, Dysgeusia, Malaise, Lung Disorder, Tongue Disorder, Neoplasm Malignant, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

Reported by a physician from Canada on 2012-05-23

Patient: male

Reactions: Nasopharyngitis, Pneumonia, Blood Calcium Increased, Pulmonary Embolism, Blood Phosphorus Decreased, Malaise, Heart Rate Increased, Dehydration, Carbon Dioxide Increased, Anion GAP Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg,
    Administration route: Oral
    Indication: Thymic Cancer Metastatic

Aredia
    Indication: Thymic Cancer Metastatic

Sandostatin
    Dosage: 30 mg, once in 4 weeks
    Indication: Thymic Cancer Metastatic
    Start date: 2008-12-24

Zometa
    Dosage: 4 mg every 3 weeks
    Indication: Thymic Cancer Metastatic
    Start date: 2010-05-26



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: male

Reactions: Malaise, Vomiting, Immunodeficiency, Convulsion, Influenza Like Illness

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Lamictal; Risperdal



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-22

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Weight Increased, Fatigue, Malaise, Underdose

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Small Intestine Carcinoma
    Start date: 2011-08-04

Sandostatin LAR
    Dosage: 40mg every 3 weeks
    Indication: Small Intestine Carcinoma
    Start date: 2009-03-02



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-05-21

Patient: female

Reactions: Malaise, Dyspnoea, Fatigue, Lung Disorder, Cardiac Failure, Pulmonary Oedema, Asthenia

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, every day
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2011-01-08
    End date: 2012-01-07

Sandostatin LAR
    Dosage: 50 mg, every 4 weeks
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2011-03-08



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