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Index of reports
> Serious Reactions (1078)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Afinitor (Everolimus) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 1078 Next >>
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 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 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 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
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 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 physician from Australia on 2012-08-24
Patient: female
Reactions: Femur Fracture, Fall
Drug(s) suspected as cause:
Afinitor
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 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 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 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 2012-08-22
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 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 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 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 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 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
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 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
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 50 year old male
Reported by a physician from Brazil on 2012-08-20
Patient: 50 year old male
Reactions: Oedema, Ascites
Drug(s) suspected as cause:
Afinitor
Sandostatin LAR
Possible Afinitor side effects in
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient:
Reactions: Renal Failure, Neuroendocrine Carcinoma Metastatic, Disease Progression
Drug(s) suspected as cause:
Afinitor
Dosage: unk
Indication: Neuroendocrine Carcinoma Metastatic
Sutent
Dosage: unk
Indication: Neuroendocrine Carcinoma Metastatic
Possible Afinitor side effects in female
Reported by a physician from United States on 2012-08-17
Patient: female
Reactions: Pain in Extremity, Disorientation, Rash, Somnolence, Convulsion, Paraesthesia, Burning Sensation, Fatigue, Arthralgia, Feeling Hot, Blood Cholesterol Increased, Dizziness, Asthenia, Feeling Abnormal, Lethargy
Drug(s) suspected as cause:
Afinitor
Other drugs received by patient: Lamictal; Vitamins NOS; Depo-Provera; Calcium Supplements; Sodium Bicarbonate; Tegretol; Sabril; Keppra; Vitamin D; Klonopin; Prilosec; Topamax
Possible Afinitor side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: male
Reactions: Vomiting, Coma, Rhinorrhoea, Ear Infection, Somnolence, Ocular Neoplasm, Diarrhoea, Electrolyte Imbalance, Complex Partial Seizures, Cough, Infantile Spasms
Drug(s) suspected as cause:
Afinitor
Dosage: 2.5 mg, daily
Administration route: Oral
Indication: Tuberous Sclerosis
Start date: 2011-07-13
Afinitor
Dosage: 5 mg
Administration route: Oral
Start date: 2011-07-13
Other drugs received by patient: Miralax; Zonegran; Topamax; Vigabatrin; Phenobarbital TAB; Taurine; Sabril; Vitamin B6
Possible Afinitor side effects in female
Reported by a physician from Korea, Republic of on 2012-08-17
Patient: female, weighing 51.8 kg (114.0 pounds)
Reactions: Confusional State, Blood Urea Increased, Blood Calcium Increased, Azotaemia, Blood Creatinine Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Afinitor
Other drugs received by patient: Norvasc; Fosamax; Irbesartan; Insulin
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 health professional (non-physician/pharmacist) from Canada on 2012-08-16
Patient: female
Reactions: Tumour Necrosis, Fatigue, Blood Bilirubin Abnormal, Oedema Peripheral, Bile Duct Cancer
Drug(s) suspected as cause:
Afinitor
Dosage: 5 mg, everyday
Administration route: Oral
Indication: Neuroendocrine Tumour
Start date: 2011-06-23
Sandostatin LAR
Dosage: 30 mg, every four weeks
Indication: Neuroendocrine Tumour
Start date: 2011-04-20
Possible Afinitor side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: male, weighing 102.5 kg (225.5 pounds)
Reactions: Gouty Arthritis, Metastases To Pituitary Gland, Oedema Peripheral, Pigmentation Disorder, Rash, White Blood Cell Count Increased, Infection
Drug(s) suspected as cause:
Afinitor
Other drugs received by patient: Keppra; Testosterone; Allopurinol; Norvasc
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