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Nexavar (Sorafenib) - Serious Reactions - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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



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



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