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Nexavar (Sorafenib) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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 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 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 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 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 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 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 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: Yodel; Novolin R; Marzulene S; Diltiazem HCL; Lendormin; Berizym [enzymes Nos]; Aspirin; Magmitt; Oradol; Pravastatin Sodium; Tamsulosin HCL; Casodex; Lansoprazole



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



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