Index of reports
> All Cases (1969)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nexavar (Sorafenib) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 1969 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 35 year old male
Reported by a physician from Japan on 2012-08-27
Patient: 35 year old male, weighing 68.3 kg (150.3 pounds)
Reactions: Hepatic Function Abnormal
Adverse event resulted in: death
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg (daily dose), , oral
Administration route: Oral
Start date: 2010-06-18
End date: 2010-06-19
Nexavar
Dosage: 400 mg (daily dose), , oral
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-06-11
End date: 2010-06-17
Other drugs received by patient: Fentanyl-100; Oxycontin; Restamin; Primperan TAB; Omeprazole; Magmitt; Enteronon R; Cefazolin Sodium; Ketoprofen; Celecoxib; Pursennid; Zometa; Baraclude; Prochlorperazine; Acetaminophen; Wystal; Enteronon R; Oxycodone Hydrochloride; Primperan TAB; Primperan TAB
Possible Nexavar side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 54 year old male
Reactions: Blood Pressure Increased, Weight Decreased, Nausea, Pain in Extremity, Hypotension, Rash, Skin Irritation, Frequent Bowel Movements, Fatigue, Diarrhoea, Gait Disturbance, Decreased Appetite
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 59 year old female
Reported by a physician from United States on 2012-08-27
Patient: 59 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Weight Decreased, Peripheral Coldness, Vomiting, Glossodynia, Nausea, Pain, Rash, Hyperhidrosis, Constipation, Erythema, Fatigue, Diarrhoea, Dehydration, Feeling Hot, Dizziness, Cold Sweat, Blister
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, daily
Administration route: Oral
Start date: 2012-07-14
Nexavar
Dosage: 400 mg, qd
Indication: Hepatic Neoplasm Malignant
Start date: 2012-05-09
Nexavar
Dosage: 400 mg, bid
Start date: 2012-05-19
Nexavar
Dosage: 400 mg am and 200 mg pm
End date: 2012-07-11
Possible Nexavar side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Death, Adverse Drug Reaction, Toxicity To Various Agents
Adverse event resulted in: death
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 62 year old male
Reported by a physician from Japan on 2012-08-27
Patient: 62 year old male
Reactions: Diarrhoea, Cerebral Infarction, Palmar-Plantar Erythrodysaesthesia Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-06-21
End date: 2010-10-11
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2010-10-12
End date: 2010-11-19
Possible Nexavar side effects in 67 year old male
Reported by a physician from Korea, Republic of on 2012-08-24
Patient: 67 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Diarrhoea, Febrile Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 800 mg
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-03-09
End date: 2011-04-13
Nexavar
Dosage: daily dose 400 mg
Administration route: Oral
Start date: 2011-04-14
End date: 2011-08-26
Possible Nexavar side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24
Patient: 73 year old female, weighing 48.0 kg (105.6 pounds)
Reactions: Hyperbilirubinaemia, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Palmar-Plantar Erythrodysaesthesia Syndrome, General Physical Health Deterioration, Encephalopathy, Dizziness, Hypertension, Decreased Appetite
Adverse event resulted in: death
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-01-08
End date: 2010-01-10
Nexavar
Dosage: 800 mg, qd
Administration route: Oral
Start date: 2010-01-13
End date: 2010-01-19
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2010-01-20
End date: 2010-03-02
Other drugs received by patient: Aldactone; Shakuyakukanzoutou; Omeprazole; Urso 250; Medicon; Allegra; Acetaminophen; Onealfa
Possible Nexavar side effects in 65 year old male
Reported by a physician from Japan on 2012-08-24
Patient: 65 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: C-Reactive Protein Increased, Diarrhoea, Aspartate Aminotransferase Increased, Pyrexia, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2012-05-15
End date: 2012-07-27
Nexavar
Dosage: daily dose 400 mg
Administration route: Oral
Start date: 2012-08-03
Other drugs received by patient: Loxonin; Lendormin; Livact; Allopurinol; Amlodipine; Micardis; Pravastatin Sodium; Urso 250; Lansoprazole; Pursennid; Doxazosin Mesylate; Enalapril Maleate
Possible Nexavar side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: female
Reactions: Transient Ischaemic Attack
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in male
Reported by a pharmacist from United States on 2012-08-24
Patient: male
Reactions: Nephrolithiasis, Blood Urine Present
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 78 year old female
Reported by a physician from Czech Republic on 2012-08-24
Patient: 78 year old female, weighing 58.0 kg (127.6 pounds)
Reactions: Cardiac Failure, Malnutrition
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400mg daily
Administration route: Oral
Start date: 2010-06-03
End date: 2010-06-17
Nexavar
Dosage: 800mg daily
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-04-20
End date: 2010-06-02
Other drugs received by patient: Enalapril Maleate; Furosemide; Spironolactone; Furosemidum; Furosemidum
Possible Nexavar side effects in 66 year old male
Reported by a physician from Taiwan, Province of China on 2012-08-24
Patient: 66 year old male, weighing 58.0 kg (127.6 pounds)
Reactions: Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2011-05-14
End date: 2011-05-20
Nexavar
Dosage: 0 mg
Start date: 2011-04-06
End date: 2011-04-07
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2011-04-08
End date: 2011-05-06
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Start date: 2011-05-07
End date: 2011-05-11
Nexavar
Dosage: 0 mg
Start date: 2011-05-12
End date: 2011-05-13
Nexavar
Dosage: 0 mg
Start date: 2011-05-21
End date: 2011-05-25
Nexavar
Dosage: 400 mg bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-03-25
End date: 2011-04-05
Other drugs received by patient: Lansoprazole; Loperamide; Omnipaque 140; Omnipaque 140; Diclofenac Sodium; Gascon; Scopolamine; Glipizide; Corticosteroids, Dermatological Preparations; Lansoprazole; Xylocaine; Corticosteroids, Dermatological Preparations; Furosemide; Loperamide; Etofenamate; Alminox
Possible Nexavar side effects in 76 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 76 year old female, weighing 68.9 kg (151.7 pounds)
Reactions: Aphagia, Vomiting, Nausea
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 58 year old female, weighing 89.5 kg (197.0 pounds)
Reactions: Migraine, Respiratory Failure, Mitral Valve Incompetence
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2010-03-11
End date: 2010-04-08
Nexavar
Dosage: cycle 8 - as used dose: 400-200 mg
Administration route: Oral
Start date: 2010-08-03
End date: 2010-08-05
Nexavar
Dosage: cycle 10-due to subject error
Administration route: Oral
Start date: 2010-09-19
End date: 2010-09-20
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2010-01-15
End date: 2010-02-08
Nexavar
Dosage: cycle 10 - as used does: 400-200 mg
Administration route: Oral
Start date: 2010-09-21
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Thyroid Cancer Metastatic
Start date: 2009-12-17
End date: 2010-01-15
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2010-02-08
End date: 2010-03-11
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2010-04-08
End date: 2010-04-13
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Start date: 2010-05-21
End date: 2010-06-23
Nexavar
Dosage: cycle 9 - as used dose: 400-200 mg
Administration route: Oral
Start date: 2010-08-05
End date: 2010-09-01
Nexavar
Dosage: cycle 12 : 400+200 mg qd
Administration route: Oral
Start date: 2010-09-23
End date: 2010-11-26
Other drugs received by patient: Synthroid; Lisinopril; Trazodone Hydrochloride; Pristiq; Ativan; Vitamin D; Lomotil [diphenoxylate Hydrochloride]; Dilaudid; Ambien; Hyzaar; Prednisone TAB; Valium; Sodium Chloride; Lorazepam; Calcium Carbonate; Procardia XL; Fiorinal W / Codeine; Fioricet W / Codeine; Procardia XL; Sodium Chloride
Possible Nexavar side effects in female
Reported by a pharmacist from United States on 2012-08-23
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: nexavar 200mg, 400mg bid, oral
Administration route: Oral
Start date: 2012-08-14
Nexavar
Dosage: nexavar 200mg, 400mg bid, oral
Administration route: Oral
Start date: 2012-08-16
Possible Nexavar side effects in 59 year old male
Reported by a physician from France on 2012-08-23
Patient: 59 year old male, weighing 120.0 kg (264.0 pounds)
Reactions: Fatigue, Hepatic Neoplasm Malignant, Hepatic Failure, Encephalopathy, Hepatic Cirrhosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Propranolol; Glucophage; Lorazepam
Possible Nexavar side effects in 77 year old male
Reported by a physician from United States on 2012-08-23
Patient: 77 year old male
Reactions: Confusional State, Aphagia, Ammonia Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, qod
Start date: 2012-07-24
End date: 2012-08-10
Nexavar
Dosage: 200 mg, bid
Indication: Hepatic Neoplasm Malignant
Start date: 2012-07-14
End date: 2012-07-18
Other drugs received by patient: Lactulose
Possible Nexavar side effects in 63 year old male
Reported by a physician from Poland on 2012-08-23
Patient: 63 year old male, weighing 72.0 kg (158.4 pounds)
Reactions: Malignant Neoplasm of Ampulla of Vater
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Zyrtec; Biotrakson; Ciprofloxacin HCL; Galec 20; Enoxaparin Sodium; Ciprofloxacin HCL; Glucose Injection; Hepa-Merz [ornithine Aspartate]
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
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient:
Reactions: Vomiting, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2012-04-04
End date: 2012-04-13
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2012-05-01
End date: 2012-05-19
Noroxin
Dosage: 400 mg, bid
Administration route: Oral
Indication: Urinary Tract Infection
Start date: 2012-04-11
End date: 2012-04-17
Other drugs received by patient: Ramipril; Atorvastatin; Valsartan; Rabeprazole Sodium; Prednisone TAB; Novatrex (Azithromycin); Atarax; Diltiazem HCL; Folic Acid; Glimepiride
Possible Nexavar side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 55 year old male
Reactions: Jaundice, Abdominal Pain, Hyperkalaemia, Chills, Mental Status Changes, Pyrexia, Loss of Consciousness, Death, Hepatic Encephalopathy, Fatigue, Cholangitis, Pleural Effusion, Thrombocytopenia, Renal Failure Acute, Nausea, Malnutrition, Urinary Tract Infection, Anaemia, Hyponatraemia, Rash, Bacteraemia, Dehydration, Ammonia Increased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, bid
Indication: Hepatic Neoplasm Malignant
Start date: 2012-05-25
End date: 2012-06-05
Nexavar
Dosage: 400 mg, bid
Start date: 2012-06-01
Other drugs received by patient: Lorazepam; Diphenoxylate HCL and Atropine Sulfate; Lortab; Lasix; Albuterol; Aldactone; Protonix
Possible Nexavar side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 61 year old male
Reactions: Aphagia, Blood Bilirubin Increased, Bedridden
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Nexavar
Dosage: 400 mg am + 200 mg pm
Administration route: Oral
End date: 2012-07-01
Possible Nexavar side effects in 61 year old male
Reported by a consumer/non-health professional from China on 2012-08-22
Patient: 61 year old male, weighing 51.0 kg (112.2 pounds)
Reactions: Fatigue, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Erlotinib Hydrochloride
Dosage: 50 mg, qd
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-09-28
End date: 2012-07-25
Nexavar
Dosage: 400 mg, qd
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2010-01-25
End date: 2012-08-01
Other drugs received by patient: Ascorbic Acid; Herbal Preparation; Vitamin B Complex CAP
Possible Nexavar side effects in 58 year old female
Reported by a physician from Korea, Republic of on 2012-08-22
Patient: 58 year old female, weighing 37.0 kg (81.4 pounds)
Reactions: Fanconi Syndrome, Lung Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Capecitabine
Dosage: 2900 mg, qd
Indication: Gastric Cancer
Start date: 2012-03-08
End date: 2012-03-22
Capecitabine
Dosage: 2900 mg, qd
Start date: 2012-03-28
End date: 2012-04-09
Cisplatin
Dosage: 118 mg
Start date: 2012-03-28
End date: 2012-03-28
Cisplatin
Dosage: 118 mg
Indication: Gastric Cancer
Start date: 2012-03-08
End date: 2012-03-08
Nexavar
Dosage: 400 mg, bid
Indication: Gastric Cancer
Start date: 2012-06-30
End date: 2012-07-14
Other drugs received by patient: Enoxaparin; Levofloxacin; Nystatin; Nystatin; Enoxaparin; Enoxaparin; Piperacillin / Tazobactam; Bromhexin; Ceftriaxone; Ambroxol; Meropenem; Moxifloxacin; Azithromycin; Ceftriaxone; Acetylcysteine; Azithromycin
Possible Nexavar side effects in 69 year old female
Reported by a physician from Denmark on 2012-08-22
Patient: 69 year old female
Reactions: Hepatic Neoplasm Malignant, JAW Fracture, Loose Tooth, Dental Leakage
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 58 year old female
Reactions: Fatigue, Arthralgia, Abasia, DRY Skin, Blister
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in male
Reported by a consumer/non-health professional from China on 2012-08-21
Patient: male
Reactions: Paralysis, Dermatomyositis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in male
Reported by a physician from Japan on 2012-08-21
Patient: male
Reactions: Hepatic Function Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-21
Patient: 63 year old female, weighing 48.1 kg (105.8 pounds)
Reactions: Blood Creatine Phosphokinase Increased, Angina Unstable, Palmar-Plantar Erythrodysaesthesia Syndrome, Wound Infection, Blood Creatine Phosphokinase MB Increased, Malaise, C-Reactive Protein Increased, Diarrhoea, Impaired Healing, Hepatectomy, Chest Pain, Platelet Count Decreased, Skin Necrosis, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, tid
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-01-07
End date: 2011-01-28
Nexavar
Dosage: 200 mg, tid
Administration route: Oral
Indication: Metastases To Lung
Start date: 2011-03-05
End date: 2011-03-24
Nexavar
Dosage: 200 mg, tid
Administration route: Oral
Start date: 2011-03-17
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2011-04-22
End date: 2011-08-22
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2011-10-25
End date: 2011-10-30
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2011-08-31
End date: 2011-10-23
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2011-11-03
Other drugs received by patient: Urepearl; Epirubicin Hydrochloride; Famotidine; Amlodipine; Miriplatin
Page 1 Next >>
|