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Afinitor (Everolimus) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (2235)

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

 Reports 1 - 30 of 2235   Next >>

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

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Renal Disorder

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 69 year old female

Reactions: Urinary Tract Infection, Metastatic Renal Cell Carcinoma, Disease Progression

Drug(s) suspected as cause:
Afinitor
    Indication: Breast Cancer

Lipitor

Sutent
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-04-19
    End date: 2012-06-01

Other drugs received by patient: Tramadol; Vitamin D; Nolvadex; Oxycodone; Tizanidine; Tylenol; Oystcal; Bactrim; Nitroglycerin



Possible Afinitor side effects in female

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

Patient: female

Reactions: Stomatitis, Gout, Dehydration, Hyponatraemia, Arthritis, Synovial Fluid Crystal Present, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Clodronate Disodium; Coumadin; Exemestane



Possible Afinitor side effects in female

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

Patient: female, weighing 85.9 kg (189.0 pounds)

Reactions: Affective Disorder, Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Lymphangioleiomyomatosis
    Start date: 2010-05-20
    End date: 2011-02-24

Afinitor
    Dosage: code not broken
    Administration route: Oral
    Start date: 2011-03-25

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Lymphangioleiomyomatosis
    Start date: 2010-05-20
    End date: 2011-02-24

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Start date: 2011-03-25

Placebo
    Dosage: code not broken
    Administration route: Oral
    Start date: 2011-03-25

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Lymphangioleiomyomatosis
    Start date: 2010-05-20
    End date: 2011-02-24

Other drugs received by patient: Sabril; Leptilan; Implanon; Lamotrigine; Levothyroxine Sodium; Melperon; Torsemide; Hydrochlorothiazide



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 female

Reported by a consumer/non-health professional from Canada on 2012-08-26

Patient: female

Reactions: Dyspnoea, Drug Ineffective, Pain, Localised Oedema, Neoplasm Progression, Cyst, Somnolence, Fatigue, Arthralgia, Neck Pain, Joint Swelling, Arthritis, Immobile, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, (every day)
    Administration route: Oral
    Indication: Carcinoid Tumour
    Start date: 2011-08-01
    End date: 2012-02-23

Sandostatin LAR
    Dosage: 30 mg, qmo
    Indication: Carcinoid Tumour
    Start date: 2006-09-01

Other drugs received by patient: Dacarbazine



Possible Afinitor side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Dyspnoea, Pneumonia, Tachycardia, Pyrexia, Multi-Organ Failure, Oedema, Hypoxia, Urosepsis, Asthenia, Escherichia Infection, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Duoneb; Lovenox; Xanax; Benadryl; Metoprolol Tartrate; Vicodin; Protonix



Possible Afinitor side effects in female

Reported by a physician from Australia on 2012-08-24

Patient: female

Reactions: Femur Fracture, Fall

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

Reported by a physician from Germany on 2012-08-24

Patient: female, weighing 91.0 kg (200.2 pounds)

Reactions: Vomiting, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor



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 female

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

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome, Device Related Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Afinitor
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 100.7 kg (221.5 pounds)

Reactions: Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Fluorouracil
    Dosage: unk
    Start date: 2012-07-29

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-29

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Paclitaxel
    Dosage: 228 mg qwk
    Start date: 2012-07-15
    End date: 2012-07-20

Paclitaxel
    Dosage: unk
    Start date: 2012-07-29

Paclitaxel
    Dosage: 228 mg qwk
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-02

Placebo
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Fentanyl; Neosporin (Neomycin Sulfate / Polymyxin B Sulfate); Senna; Bacitracin; Filgrastim; Morphine; Famotidine; Fluconazole; Eucerin; Prochlorperazine; Esomeprazole Sodium; Guaifenesin; Enoxaparin; Amoxicillin and Clavulanate Potassium; Miralax; Lidocaine; Escitalopram; Ondansetron; Rosuvastatin; Docusate; Aquaphor; Hydromorphone Hydrochloride; Nystatin



Possible Afinitor side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Dermatitis

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Abdominal Pain, Neuropathy Peripheral, Oesophageal Pain, Vomiting, Diarrhoea, Ear Pain, Gallbladder Disorder, Facial Pain

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

Afinitor
    Dosage: 10 mg, qd
    Indication: Breast Cancer
    Start date: 2012-07-05

Other drugs received by patient: Amoxicillin; Oxycodone HCL; Faslodex; Omeprazole; Fentanyl; Ondansetron; Hydrocodone; Nifedipine; Chlorhexidine Gluconate



Possible Afinitor side effects in 6 month old

Reported by a physician from United States on 2012-08-23

Patient: 6 month old

Reactions: Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in male

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

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 individual with unspecified qualification from United States on 2012-08-22

Patient: female

Reactions: Pneumonitis

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in 43 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 43 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Afinitor
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2012-05-02

Tarceva
    Dosage: 150mg unknown
    Indication: Product Used FOR Unknown Indication

Votrient
    Indication: Product Used FOR Unknown Indication



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 pharmacist from United States on 2012-08-22

Patient: male

Reactions: Lung Disorder, Dyspnoea, Oral Pain, Pain, Dizziness

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 consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Nephrolithiasis, Stomatitis, Sleep Disorder, Urinary Tract Infection, Ear Infection, Cognitive Disorder, Convulsion

Drug(s) suspected as cause:
Afinitor
    Dosage: 2.5 mg, daily
    Administration route: Oral
    Indication: Astrocytoma, LOW Grade
    Start date: 2012-01-21

Afinitor
    Dosage: 5 mg, unk
    Indication: Renal Cell Carcinoma

Afinitor
    Dosage: 2.5 mg, qd
    Indication: Tuberous Sclerosis

Other drugs received by patient: Melatonin; Melatonin; Lamotrigine; Vitamin; Keppra; Keppra



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 male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: LIP Swelling, Weight Decreased, LIP Disorder, Chapped Lips, Abnormal Behaviour, Tick-Borne Fever, LIP Haemorrhage

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, daily
    Start date: 2012-07-24

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Astrocytoma, LOW Grade
    Start date: 2011-06-23

Other drugs received by patient: Topamax; Depakote; Clonidine; Glycerin Suppositories; Lamictal; Vitamins NOS



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:
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

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



Possible Afinitor side effects in

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

Patient:

Reactions: Bone Marrow Failure

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

Reported by a physician from Ireland on 2012-08-21

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Weight Decreased, Fatigue, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2011-02-04
    End date: 2011-05-30

Comparator Trastuzumab
    Dosage: 90 mg, weekly
    Indication: Breast Cancer Metastatic
    Start date: 2011-02-04

Paclitaxel
    Dosage: 90 mg, weekly
    Start date: 2011-02-04
    End date: 2011-05-27

Paclitaxel
    Dosage: 60 mg/m2
    Start date: 2011-03-18
    End date: 2011-04-15

Other drugs received by patient: Lipitor; Micardis; Pantoprazole; Acetaminophen; Pantoprazole; Valoid



Possible Afinitor side effects in male

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

Patient: male

Reactions: Pain, Kidney Transplant Rejection, Constipation, Hypoxia, Inappropriate Antidiuretic Hormone Secretion, Decreased Appetite, Metabolic Acidosis, Dyspnoea, Hyperglycaemia, Anaemia, Hyponatraemia, Renal Failure, Lung Disorder, Diarrhoea, Metastases To Spine, Dehydration, Radiation Pneumonitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Prednisone; Furosemide; Metoprolol Tartrate; Radiation Therapy; Magnesium Oxide; Glipizide; Lipitor



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



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