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Index of reports
> Serious Reactions (1033)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nexavar (Sorafenib) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 1033 Next >>
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 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 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 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 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 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 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 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 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 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 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
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 22 year old male
Reported by a physician from Spain on 2012-08-20
Patient: 22 year old male
Reactions: Mucosal Inflammation, Pulmonary Tuberculosis, Alopecia, Palmar-Plantar Erythrodysaesthesia Syndrome, Erythema Multiforme
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Start date: 2009-01-01
Nexavar
Dosage: 400 mg, bid
Administration route: Oral
Indication: Angiosarcoma
Start date: 2009-10-01
Nexavar
Dosage: 200 mg, every 36 hours
Administration route: Oral
Start date: 2011-01-01
Possible Nexavar side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient: 58 year old male
Reactions: Weight Decreased, Fatigue, Neck Pain, Musculoskeletal Stiffness, Blood Glucose Fluctuation, Gallbladder Disorder, Gastrooesophageal Reflux Disease, Muscle Spasms, Decreased Appetite, Back Pain, Vomiting, Nausea, DRY Skin, Anxiety, Insomnia, Asthenia
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 53 year old male
Reported by a physician from Switzerland on 2012-08-20
Patient: 53 year old male
Reactions: Fatigue, Dyspnoea, Mouth Haemorrhage, Metastases To Bone, Epistaxis
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient: 67 year old female
Reactions: Adverse Drug Reaction, Oropharyngeal Pain, Constipation, Pharyngeal Oedema, Hair Texture Abnormal, Oedema Peripheral, DRY Mouth, Blister, LIP DRY, Pain in Extremity, Palmar-Plantar Erythrodysaesthesia Syndrome, Ear Infection, Antibiotic Therapy, Arthralgia, Diarrhoea, Limb Injury, Joint Swelling, Alopecia, Hair Disorder
Drug(s) suspected as cause:
Nexavar
Dosage: 200 mg, bid
Administration route: Oral
Indication: Thyroid Cancer
Start date: 2009-07-09
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Nexavar
Dosage: 200 mg, qd
Administration route: Oral
Nexavar
Possible Nexavar side effects in
Reported by a pharmacist from Germany on 2012-08-20
Patient:
Reactions: Epilepsy
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 65 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 65 year old male
Reactions: Tumour Necrosis, Vomiting, Nausea, Musculoskeletal Pain, Pain, Neoplasm Progression, Pyrexia, Weight Increased, Diarrhoea, Nail Disorder
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-17
Patient: 63 year old male, weighing 67.0 kg (147.4 pounds)
Reactions: Weight Decreased, Blood Pressure Increased, Abdominal Pain, Back Pain, Urinary Tract Infection, Diplopia, Diarrhoea, Metastases To Bone, Eye Disorder, Decreased Appetite
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Preparations Increasing Uric Acid Excretion; Omeprazole; Captopril; Hydrochlorothiazide; Preparations Increasing Uric Acid Excretion; Preparations Increasing Uric Acid Excretion; Preparations Increasing Uric Acid Excretion; Hydrochlorothiazide
Possible Nexavar side effects in 53 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 53 year old male
Reactions: Confusional State, Agitation, Dysphagia, Pain, Anaemia, Failure To Thrive, Hypokalaemia, Death, Fatigue, Fluid Intake Reduced, Asthenia, Decreased Appetite, Deep Vein Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg am, 200 mg pm x 21days
Indication: Colorectal Cancer Metastatic
Start date: 2012-06-22
End date: 2012-08-07
Xeloda
Dosage: 1500 mg am, 1650 mg pm x 14 days
Indication: Colorectal Cancer Metastatic
Start date: 2012-06-22
End date: 2012-08-01
Other drugs received by patient: Roxicodone; Compazine; Ferrous Fumarate; MS Contin; Phenergan HCL; Prinzide; Multi-Vitamin; Compazine
Possible Nexavar side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male
Reactions: Paresis, Hypoaesthesia Oral, Hypoaesthesia, Blindness, Muscle Spasms
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: 54 year old male
Reactions: Frequent Bowel Movements, Diarrhoea, Pain in Extremity, Rash, Gait Disturbance, Skin Irritation
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 79 year old male
Reported by a physician from Japan on 2012-08-16
Patient: 79 year old male, weighing 56.0 kg (123.2 pounds)
Reactions: Proteinuria, Hypertension, Nephrotic Syndrome, Haemorrhage Subcutaneous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexavar
Dosage: daily dose 400 mg
Administration route: Oral
Indication: Hepatic Neoplasm Malignant
Start date: 2011-01-20
End date: 2011-03-23
Nexavar
Dosage: daily dose 200 mg
Start date: 2011-03-24
End date: 2011-07-07
Other drugs received by patient: Diovan; Hirudoid; Doxazosin Mesylate; Tagamet; Depas; Maglax; Lasix; Acetylol; Cibenol; Zolpidem; Urinorm; Adalat CC; Doxazosin Mesylate; Irgas; Gorei-SAN; Hyalein; Loxonin; Lasix; Lasix; Azulene-Glutamine; Cephadol
Possible Nexavar side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: 60 year old male
Reactions: Platelet Count Decreased, Blood Count Abnormal, Infection
Drug(s) suspected as cause:
Nexavar
Dosage: 400 mg, qd at h.s.
Administration route: Oral
Start date: 2012-08-08
Nexavar
Dosage: unk
Indication: Hepatic Neoplasm Malignant
Start date: 2012-05-23
End date: 2012-06-03
Possible Nexavar side effects in 77 year old male
Reported by a physician from Japan on 2012-08-15
Patient: 77 year old male
Reactions: Hepatic Function Abnormal
Drug(s) suspected as cause:
Nexavar
Possible Nexavar side effects in 62 year old male
Reported by a physician from Japan on 2012-08-15
Patient: 62 year old male, weighing 58.0 kg (127.6 pounds)
Reactions: White Blood Cell Count Decreased, Blood Lactate Dehydrogenase Increased, Mean Cell Volume Decreased, Pyrexia, Blood Creatinine Decreased, Haematocrit Decreased, Tumour Lysis Syndrome, C-Reactive Protein Increased, Blood Uric Acid Increased
Drug(s) suspected as cause:
Nexavar
Other drugs received by patient: Lisinopril; Loxonin; Rebamipide; Famotidine; Allegra; Antebate; Baraclude; Pastaron
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