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Afinitor (Everolimus) - Neoplasm Malignant - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Neoplasm Malignant (362)

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

 Reports 1 - 30 of 362   Next >>

Possible Afinitor side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Stomatitis, Headache, Pyrexia, Rash, Sebaceous Carcinoma, Convulsion, Neoplasm Malignant, Diarrhoea, Dermal Cyst

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Vitamin E; Vitamins NOS; Multivitamin; Trileptal; Keppra; DHA; Hydra-Zide; Lisinopril; Ventolin; Vitamin D; Allegra; Fish OIL; Vimpat



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-08-27

Patient: male

Reactions: Osteonecrosis of JAW, Neoplasm Malignant, Neoplasm Progression, Osteomyelitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-03-18
    End date: 2011-07-01

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2012-01-12

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-08-05
    End date: 2011-09-04

Zometa
    Dosage: 4 mg, unk
    Indication: Metastases To Bone
    Start date: 2009-05-26
    End date: 2009-05-26

Zometa
    Dosage: 4 mg, unk
    Start date: 2011-01-31
    End date: 2011-01-31

Other drugs received by patient: Sorafenib Tosilate; Famotidine; Lyrica; Tramadol Hydrochloride; Oxycontin; Prochlorperazine; Hachiazule; Sunitinib Malate; Acetaminophen; Neurotropin; Clarithromycin; Onealfa



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 male

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

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Renal Impairment, C-Reactive Protein Increased, Neoplasm Malignant, Neoplasm Progression, Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2012-01-06
    End date: 2012-01-09

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-12-14
    End date: 2011-12-29

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-06-20
    End date: 2011-10-03

Etodolac
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma

Prednisolone
    Dosage: 5 mg
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-06-21
    End date: 2011-09-01

Zometa
    Dosage: unk ukn, unk
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-06-27

Other drugs received by patient: Allopurinol; Benidipine Hydrochloride; Vitamin B12; Limaprost Alfadex; Lansoprazole; Limaprost Alfadex; Flivas; Acetaminophen



Possible Afinitor side effects in 72 year old male

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

Patient: 72 year old male

Reactions: Cardiac Valve Disease, Cachexia, Neoplasm Malignant, Interstitial Lung Disease, Cardiac Failure, Neoplasm Progression, Metastases To Peritoneum, Asthenia, Ascites

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Stomatitis, Pyrexia, Headache, Sebaceous Carcinoma, Convulsion, Diarrhoea, Neoplasm Malignant, Dermal Cyst

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Vitamin E; Vitamins NOS; Allegra; Fish OIL; DHA; Multivitamin; Vimpat; Trileptal; Vitamin D; Hydra-Zide; Keppra; Lisinopril; Ventolin



Possible Afinitor side effects in female

Reported by a physician from South Africa on 2012-08-22

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Diabetic Ulcer, Hyperglycaemia, Hyponatraemia, Neoplasm Progression, Hypokalaemia, Renal Impairment, Neoplasm Malignant, Skin Lesion, Sepsis, Dehydration, Cardiac Arrest, Pneumonitis

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

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Comparator Trastuzumab
    Dosage: 2 mg/kg, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Paclitaxel
    Dosage: 80 mg/m2, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Other drugs received by patient: Zamanon; Marinol; Metformin; Maxolon



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 male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male

Reactions: Neoplasm Malignant, Neoplasm Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Zocor; Aspirin



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Australia on 2012-08-17

Patient: female

Reactions: Neoplasm Malignant, Impaired Healing, Neoplasm Progression, Injury, Intracranial Pressure Increased, Infection

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Australia on 2012-08-14

Patient: female

Reactions: Neoplasm Malignant, Impaired Healing, Neoplasm Progression, Injury, Intracranial Pressure Increased, Infection

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient: 77 year old female

Reactions: Neoplasm Malignant, Urticaria, Neoplasm Progression, Oedema, Blister

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

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

Patient: female

Reactions: Blood Creatinine Decreased, Neoplasm Malignant, Gamma-Glutamyltransferase Increased, C-Reactive Protein Increased, Neoplasm Progression, Liver Disorder, Lymphocyte Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, daily (on odd days)
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-03

Afinitor
    Dosage: 10 mg, daily (on even days)
    Administration route: Oral
    Start date: 2011-12-22

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2012-01-05
    End date: 2012-02-15

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2012-02-16
    End date: 2012-03-16

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2011-11-07
    End date: 2011-12-21

Other drugs received by patient: Etoposide; Cisplatin



Possible Afinitor side effects in 56 year old female

Reported by a physician from Japan on 2012-08-13

Patient: 56 year old female

Reactions: Hepatic Function Abnormal, Pneumonia, Neoplasm Malignant, Blood Lactate Dehydrogenase Increased, Condition Aggravated, Neoplasm Progression, Pulmonary Mycosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-05-21
    End date: 2011-06-26

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-01-07
    End date: 2011-02-22

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-03-31
    End date: 2011-04-26

Other drugs received by patient: Codeine Phosphate; Astomin; Sunitinib Malate; Coniel; Phenobarbital TAB; Coniel; Mucodyne; Sunitinib Malate; Coniel; Astomin; Pravastatin; Metabanyl; Sunitinib Malate; Codeine Phosphate; Urso 250



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 male

Reported by a physician from United States on 2012-08-09

Patient: male

Reactions: Stomatitis, Pyrexia, Headache, Sebaceous Carcinoma, Convulsion, Neoplasm Malignant, Diarrhoea, Dermal Cyst

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Ventolin; Hydra-Zide; Lisinopril; DHA; Trileptal; Keppra; Allegra; Vitamins NOS; Vimpat; Vitamin E; Fish OIL; Vitamin D; Multivitamin



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-06

Patient: female

Reactions: Drug Ineffective, Neoplasm Progression, Abdominal Pain Upper, Death, Fatigue, Neoplasm Malignant, Sleep Disorder, Platelet Count Decreased, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour Metastatic
    Start date: 2011-11-22
    End date: 2011-12-19

Afinitor
    Dosage: 5 mg, every day
    Administration route: Oral
    Start date: 2011-12-20
    End date: 2012-02-28

Afinitor
    Dosage: 10 mg every other day
    Administration route: Oral
    Start date: 2012-02-28
    End date: 2012-03-05

Afinitor
    Dosage: 05 mg every other day
    Administration route: Oral
    Start date: 2012-02-29
    End date: 2012-03-06



Possible Afinitor side effects in male

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

Patient: male

Reactions: Neoplasm Malignant, Neoplasm Progression, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Renal Cell Carcinoma
    Start date: 2011-01-28
    End date: 2011-03-03

Sunitinib Malate
    Dosage: unk
    Indication: Renal Cell Carcinoma
    Start date: 2010-02-17
    End date: 2011-04-07

Other drugs received by patient: Amoxicillin; Ramipril



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male

Reactions: Neoplasm Malignant, Neoplasm Progression, Eating Disorder

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 male

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

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: PO2 Decreased, Neoplasm Malignant, C-Reactive Protein Increased, Neoplasm Progression

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2010-08-24
    End date: 2010-09-05

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-07-05
    End date: 2010-08-02

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2010-09-17
    End date: 2010-09-30

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2010-10-18
    End date: 2011-01-25



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in 64 year old male

Reported by a physician from Israel on 2012-07-26

Patient: 64 year old male

Reactions: Metastasis, Neoplasm Malignant, Neoplasm Progression, General Physical Health Deterioration

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

Sandostatin LAR
    Dosage: 30 mg once in every 28 days
    Start date: 2012-06-13

Sandostatin LAR
    Dosage: 30 mg once in every 28 days
    Indication: Carcinoid Tumour
    Start date: 2009-07-06



Possible Afinitor side effects in female

Reported by a physician from Japan on 2012-07-26

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Type 2 Diabetes Mellitus, Neoplasm Malignant, Interstitial Lung Disease, Drug Ineffective, Neoplasm Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2012-02-02
    End date: 2012-04-12

Amlodipine Besylate
    Administration route: Oral



Possible Afinitor side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Mucosal Inflammation, Neoplasm Malignant, Nausea, Anaemia, Neoplasm Progression, Oedema

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Aromasin; Regelan; Nexium; Iron; Vitamin D High CAP Potency; Lasix; Phenergan HCL; Krill OIL; Ascorbic Acid; Zofran



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-07-20

Patient: female

Reactions: Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor



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 2012-07-13

Patient: male

Reactions: Jaundice, Weight Decreased, Blood Bilirubin Increased, White Blood Cell Count Decreased, Neoplasm Progression, Hepatic Enzyme Increased, Liver Disorder, Haemoglobin Decreased, Abdominal Discomfort, Fatigue, Neoplasm Malignant, Platelet Count Decreased, Neutrophil Count Decreased

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2011-10-27
    End date: 2012-04-23

Afinitor
    Dosage: 10 mg, every day
    Administration route: Oral
    Indication: Neuroendocrine Carcinoma Metastatic
    Start date: 2011-10-15

Afinitor
    Dosage: 10 mg, every other day (for a month)
    Administration route: Oral

Sandostatin LAR
    Dosage: 30 mg, every 4 weeks
    Indication: Neuroendocrine Tumour
    Start date: 2011-07-14

Other drugs received by patient: Gabapentin; Pancrease; Pantoprazole Sodium; Dexamethasone



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-07-09

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Respiratory Disorder, Anaemia, Neoplasm Progression, Neoplasm Malignant, C-Reactive Protein Increased, Interstitial Lung Disease, Palpitations, Oedema Peripheral

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Prednisolone; Methylprednisolone Sodium Succinate; Sorafenib Tosilate; Methylprednisolone Sodium Succinate; Methylprednisolone Sodium Succinate; Sumiferon



Possible Afinitor side effects in male

Reported by a physician from Japan on 2012-07-09

Patient: male

Reactions: Osteonecrosis of JAW, Neoplasm Malignant, Osteomyelitis, Neoplasm Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-08-05
    End date: 2011-09-04

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2012-01-12

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-03-18
    End date: 2011-07-01

Zometa
    Dosage: 4 mg, unk
    Start date: 2011-01-31
    End date: 2011-01-31

Zometa
    Dosage: 4 mg, unk
    Indication: Metastases To Bone
    Start date: 2009-05-26
    End date: 2009-05-26

Other drugs received by patient: Sunitinib Malate; Hachiazule; Onealfa; Neurotropin; Oxycontin; Sorafenib Tosilate; Acetaminophen; Famotidine; Clarithromycin; Tramadol Hydrochloride; Lyrica; Prochlorperazine



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