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Index of reports
> Life Threatening Events (145)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nexavar (Sorafenib) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 145 Next >>
Possible Nexavar side effects in 57 year old male
Reported by a physician from Spain on 2012-08-27
Patient: 57 year old male
Reactions: Cerebral Haemorrhage, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Certican; Dezacor; Fluconazole; Prograf; Dezacor; Lantus; Alprazolam; Mycophenolate Mofetil (Cellcept); Pantoprazole; Ibuprofen; Omeprazole; Apidra; Lantus; Lantus; Mycophenolate Mofetil (Cellcept); Enoxaparin Sodium
Possible Nexavar side effects in 75 year old male
Reported by a physician from Japan on 2012-08-23
Patient: 75 year old male, weighing 42.0 kg (92.4 pounds)
Reactions: Palpitations, Acute Myocardial Infarction, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Start date: 2012-04-08
End date: 2012-07-24
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2012-02-08
End date: 2012-03-07
Other drugs received by patient: Amlodipine
Possible Nexavar side effects in 70 year old male
Reported by a physician from Japan on 2012-08-20
Patient: 70 year old male
Reactions: Hepatic Encephalopathy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 80 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-14
Patient: 80 year old female
Reactions: Abdominal Pain, Hypertension
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Aspirin
Dosage: daily dose 100 mg
Administration route: Oral
Start date: 2007-01-01
End date: 2008-11-04
Nexavar
Dosage: daily dose 400 mg
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2008-10-07
End date: 2008-10-14
Other drugs received by patient: Nebivolol HCL; Tramadol HCL
Possible Nexavar side effects in 54 year old male
Reported by a physician from Japan on 2012-08-13
Patient: 54 year old male, weighing 40.5 kg (89.1 pounds)
Reactions: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Pneumonia, Hepatic Function Abnormal, Anaemia, Constipation, Ascites, Diarrhoea, Platelet Count Decreased, Metastases To Bone, Liver Carcinoma Ruptured, Bilirubin Conjugated Increased, Decreased Appetite
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2009-08-10
End date: 2009-09-10
Nexavar
Dosage: 600 mg, qd
Administration route: Oral
Start date: 2009-09-12
End date: 2009-09-25
Other drugs received by patient: Fentanyl-100; TPN; Zolpidem; Bismuth Subnitrate; Voltaren; Lansoprazole; Albumin Tannate; Oxycodone Hydrochloride; Elemenmic
Possible Nexavar side effects in 71 year old male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 71 year old male, weighing 66.5 kg (146.3 pounds)
Reactions: Dyspnoea, Lymphopenia, Pleural Effusion, Rash
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Bortezomib
Dosage: dose: 1.3 mg/m2
Start date: 2012-07-11
End date: 2012-07-11
Bortezomib
Dosage: dose: 1.3 mg/m2
Indication: Metastatic Malignant Melanoma
Start date: 2012-07-03
End date: 2012-07-03
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Metastatic Malignant Melanoma
Start date: 2012-07-03
End date: 2012-07-15
Other drugs received by patient: Lidocaine; Senna-Mint WAF; Tamsulosin HCL; Prednisone TAB; Fish OIL; Glucosamine; Diphenhydramine Hydrochloride; Lisinopril; Magnesium Hydroxide TAB; Lipitor; Zofran; Lidex; Omeprazole; Aspirin
Possible Nexavar side effects in male
Reported by a pharmacist from United States on 2012-08-09
Patient: male, weighing 74.0 kg (162.8 pounds)
Reactions: Blood Bilirubin Increased, Thinking Abnormal, Aphasia, Hypophagia, Abasia, Ammonia Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 79 year old female
Reported by a physician from Japan on 2012-08-09
Patient: 79 year old female
Reactions: Diarrhoea, Abdominal Distension
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 75 year old male
Reported by a physician from Japan on 2012-08-08
Patient: 75 year old male
Reactions: Palpitations, Acute Myocardial Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2012-02-08
End date: 2012-03-07
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Start date: 2012-04-08
End date: 2012-07-24
Possible Nexavar side effects in 62 year old male
Reported by a physician from Japan on 2012-08-08
Patient: 62 year old male, weighing 57.0 kg (125.4 pounds)
Reactions: Fatigue, Dyspnoea, Diarrhoea, Bone Marrow Failure, Acute Respiratory Distress Syndrome, Decreased Appetite
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 800 mg
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2012-03-10
End date: 2012-03-20
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2012-04-01
End date: 2012-05-01
Nexavar
Dosage: 400 mg, qod
Start date: 2012-04-28
End date: 2012-04-30
Nexavar
Dosage: 200 mg, bid
Start date: 2012-03-29
End date: 2012-04-27
Other drugs received by patient: Silece; Risperidone; Zometa; Fentanyl Citrate; Lyrica; Loxonin; Lamivudine; Hepsera
Possible Nexavar side effects in 72 year old female
Reported by a physician from Japan on 2012-08-08
Patient: 72 year old female
Reactions: Drug-Induced Liver Injury
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: unknown
Indication: Product Used FOR Unknown Indication
Ranmark
Dosage: 120 mg, unk
Indication: Bone Lesion
Start date: 2012-06-27
End date: 2012-06-27
Possible Nexavar side effects in 48 year old male
Reported by a physician from Taiwan, Province of China on 2012-08-08
Patient: 48 year old male, weighing 67.7 kg (148.9 pounds)
Reactions: Hepatic Function Abnormal, Sepsis, Hepatic Failure, Constipation, Acute Respiratory Failure, Oesophageal Varices Haemorrhage
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-10-05
End date: 2011-10-25
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2011-11-15
End date: 2011-11-15
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2011-10-26
End date: 2011-11-14
Other drugs received by patient: Entecavir; Lactulose; Metoclopramide; Ultracet; Oxybutynin Chloride; Tamsulosin HCL; Esomeprazole
Possible Nexavar side effects in 49 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-07
Patient: 49 year old male, weighing 75.0 kg (165.0 pounds)
Reactions: Vena Cava Thrombosis, Pulmonary Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Aloes Extract; Halcion; Irbesartan and Hydrochlorothiazide; Nexium
Possible Nexavar side effects in 81 year old male
Reported by a physician from Japan on 2012-08-06
Patient: 81 year old male, weighing 45.8 kg (100.8 pounds)
Reactions: Neutrophil Count Increased, Hepatic Function Abnormal, Amylase Increased, Hepatic Neoplasm Malignant, Disseminated Intravascular Coagulation, Anaemia, Hyponatraemia, Pyrexia, Cardiac Failure Acute, Ascites, Platelet Count Decreased, Ammonia Increased, Lipase Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-06-10
End date: 2010-06-22
Nexavar
Dosage: 400 mg, qod
Administration route: Oral
Start date: 2010-06-24
End date: 2010-06-25
Other drugs received by patient: Magmitt; Antianaemic Preparations; Pantosin; Metilon; Aminoleban; Urso 250; Losartan Potassium; Metilon; Urepearl; Metilon; Metilon; Ferrous Sulfate TAB; Hirudoid; Metilon; Metilon
Possible Nexavar side effects in 49 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-08-02
Patient: 49 year old male
Reactions: Incoherent, Dizziness, Loss of Consciousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, qd (od)
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2011-04-21
End date: 2012-04-04
Placebo (11712)
Placebo (11712)
Dosage: unk
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2012-04-13
Other drugs received by patient: Amlodipine
Possible Nexavar side effects in 80 year old male
Reported by a physician from Germany on 2012-07-31
Patient: 80 year old male, weighing 48.0 kg (105.6 pounds)
Reactions: Speech Disorder, Cerebral Infarction, Hemiparesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 400 mg
Start date: 2009-12-18
End date: 2010-10-21
Nexavar
Dosage: interrupted
Start date: 2011-09-01
End date: 2012-05-24
Nexavar
Dosage: unk
Nexavar
Dosage: daily dose 800 mg
Indication: Hepatic Neoplasm Malignant
Start date: 2009-10-27
End date: 2009-12-17
Nexavar
Dosage: daily dose 400 mg
Start date: 2010-10-30
End date: 2011-08-31
Sorafenib (Raf Kinase Inhibitor)
Dosage: daily dose 200 mg
Start date: 2011-08-15
End date: 2011-09-01
Sorafenib (Raf Kinase Inhibitor)
Dosage: daily dose 400 mg
Indication: Hepatic Neoplasm Malignant
Start date: 2010-12-09
End date: 2011-08-15
Possible Nexavar side effects in female
Reported by a pharmacist from United Kingdom on 2012-07-27
Patient: female
Reactions: Respiratory Disorder, Chest X-RAY Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 76 year old male
Reported by a physician from Colombia on 2012-07-24
Patient: 76 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Hyperkalaemia, Impetigo, Hepatic Failure, Renal Failure Chronic, Lividity, Hepatic Encephalopathy, Diarrhoea, Oedema Peripheral, Epistaxis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Start date: 2010-01-30
End date: 2010-12-25
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2009-12-16
End date: 2010-01-27
Nexavar
Dosage: daily dose 800 mg
Start date: 2011-01-04
End date: 2011-01-11
Other drugs received by patient: Lactulosa; Furosemide; Enoxaparin; Insulin; Spironolactone; Ondansetron HCL; Midazolam; Dextrose 5%; Lactulosa; Propranolol; Midazolam; Furosemide; Dextrose 5%; Insulin; Haldol; Omeprazole; Spironolactone; Lactulosa; Haldol; Saline Solutions; NPH Insulin; Furosemide; Ampicillin and Sulbactam; Heparin; Acetylsalicylic Acid SRT; Diphenhydramine HCL
Possible Nexavar side effects in 72 year old female
Reported by a physician from Japan on 2012-07-24
Patient: 72 year old female
Reactions: Drug-Induced Liver Injury
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: unknown
Indication: Product Used FOR Unknown Indication
Ranmark
Dosage: 120 mg, unk
Indication: Bone Lesion
Start date: 2012-06-27
End date: 2012-06-27
Possible Nexavar side effects in 74 year old male
Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-07-13
Patient: 74 year old male, weighing 76.0 kg (167.2 pounds)
Reactions: Rhabdomyolysis, Fatigue, Renal Failure, Pneumonia Aspiration, Disseminated Intravascular Coagulation, Lower Gastrointestinal Haemorrhage, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 800 mg
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-02-05
End date: 2010-02-15
Placebo
Dosage: unk
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-02-05
End date: 2010-02-15
Other drugs received by patient: Isoptin; Hytrin; Celebrex; Acyclovir; Enalapril Maleate; Diltiazem HCL; Entecavir; Primperan TAB; Medroxyprogesterone Acetate; Tramadol Hydrochloride; Tamsulosin HCL; Magnesium Oxide; Xyzal; Thiamine
Possible Nexavar side effects in 85 year old male
Reported by a physician from Japan on 2012-07-06
Patient: 85 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Malaise, Hyponatraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Rebamipide; Lansoprazole; Maglax
Possible Nexavar side effects in 74 year old male
Reported by a physician from Japan on 2012-07-06
Patient: 74 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Hepatic Neoplasm Malignant, Hyperkalaemia, Disseminated Intravascular Coagulation, International Normalised Ratio Increased, Pyrexia, Hypernatraemia, Diarrhoea, Sepsis, Metastases To Central Nervous System, Decreased Appetite
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Digoxin; Lasix; Oxycontin; Magnesium Oxide; Motilium; Warfarin Sodium; Alosenn; Aldactone; Oxycodone Hydrochloride; Oxycodone Hydrochloride; Polaramine; Prochlorperazine; Lansoprazole
Possible Nexavar side effects in 85 year old male
Reported by a physician from Japan on 2012-07-05
Patient: 85 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Malaise, Hyponatraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Lansoprazole; Rebamipide; Maglax
Possible Nexavar side effects in 59 year old male
Reported by a physician from Japan on 2012-06-26
Patient: 59 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Hepatic Encephalopathy, Pneumonia, Hepatic Neoplasm Malignant, Hepatic Failure
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, qd
Start date: 2011-11-24
End date: 2011-12-06
Nexavar
Dosage: 400 mg, qod
Start date: 2011-12-14
End date: 2012-02-07
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-10-11
End date: 2011-11-24
Other drugs received by patient: Amaryl; Januvia; Iodine; Mucosta; SP; Betamethasone Sodium Phosphate; Cleanal; Minocycline Hydrochloride; Rozerem; PL Gran.; Xyzal; Baraclude; Elpinan; Loxonin; Halcion
Possible Nexavar side effects in 70 year old female
Reported by a pharmacist from United States on 2012-06-26
Patient: 70 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Stevens-Johnson Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 42 year old female
Reported by a physician from Japan on 2012-06-22
Patient: 42 year old female, weighing 40.8 kg (89.8 pounds)
Reactions: Hepatic Function Abnormal, Cholecystitis Acute, Diarrhoea, Palmar-Plantar Erythrodysaesthesia Syndrome, Platelet Count Decreased, Eosinophilia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 800 mg (daily dose), , oral
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2009-09-14
Nexavar
Dosage: 800 mg, qd
Nexavar
Dosage: 200 mg, qod
Administration route: Oral
Start date: 2009-11-17
Nexavar
Dosage: 400 mg (daily dose), , oral
Administration route: Oral
End date: 2009-10-10
Possible Nexavar side effects in 74 year old male
Reported by a physician from Japan on 2012-06-22
Patient: 74 year old male, weighing 59.0 kg (129.8 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Lansoprazole
Dosage: daily dose 15 mg
Administration route: Oral
Indication: Gastric Ulcer
Nexavar
Dosage: 400 mg daily dose
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2012-03-22
End date: 2012-04-07
Tamsulosin HCL
Dosage: daily dose 0.2 mg
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Other drugs received by patient: Torisel
Possible Nexavar side effects in 73 year old male
Reported by a physician from Japan on 2012-06-18
Patient: 73 year old male, weighing 68.0 kg (149.6 pounds)
Reactions: Toxic Encephalopathy, Shock Haemorrhagic, Palmar-Plantar Erythrodysaesthesia Syndrome, General Physical Health Deterioration, Tumour Haemorrhage, Ascites, Fatigue, Diarrhoea, Blood Uric Acid Increased
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg (daily dose), , oral
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-07-17
End date: 2010-11-03
Nexavar
Dosage: 400mg/day
Administration route: Oral
Start date: 2010-12-08
End date: 2011-03-13
Other drugs received by patient: Calblock; Lorfenamin; Rabeprazole Sodium; Losartan Potassium; Morphine HCL Elixir; Lasix; Lantus; Avapro; Lasix; Urso 250; Promac [polaprezinc]; Carbocain; Humalog; Betamethasone; Miya BM; Lactulose; Aminoleban EN
Possible Nexavar side effects in 76 year old male
Reported by a physician from Japan on 2012-06-14
Patient: 76 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Marzulene S; Magmitt; Pravastatin Sodium; Yodel; Lansoprazole; Diltiazem HCL; Tamsulosin HCL; Casodex; Aspirin; Oradol; Berizym [enzymes Nos]; Novolin R; Lendormin
Possible Nexavar side effects in 76 year old male
Reported by a physician from Japan on 2012-06-14
Patient: 76 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Yodel; Novolin R; Marzulene S; Diltiazem HCL; Lendormin; Berizym [enzymes Nos]; Aspirin; Magmitt; Oradol; Pravastatin Sodium; Tamsulosin HCL; Casodex; Lansoprazole
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