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Nexavar (Sorafenib) - Side Effect Reports to FDA

 
 



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 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 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 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 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

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 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 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 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 67 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-21

Patient: 67 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Speech Disorder, Gait Disturbance, Hypertension, Asthenia, Blood Glucose Abnormal, Convulsion

Drug(s) suspected as cause:
Nexavar

Other drugs received by patient possibly interacting with the suspect drug:
Glimepiride
    Dosage: 4 mg, bid
    Administration route: Oral
    Indication: Diabetes Mellitus

Metformin HCL
    Dosage: 85 mg, tid
    Administration route: Oral
    Indication: Diabetes Mellitus

Metformin HCL
    Dosage: 85 mg, tid
    Administration route: Oral

Propranolol
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Hypertension
    Start date: 2004-01-01

Other drugs received by patient: Levothyroxine Sodium; Doxazosin Mesylate



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



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