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Zolinza (Vorinostat) - Adverse Event Reports - Serious Event

 



Index of reports > Cases resulting in a serious event (23)

     Dehydration (8)Mycosis Fungoides (7)Weight Decreased (5)Anorexia (5)Anaemia (4)Fatigue (4)Diarrhoea (4)Nausea (3)Platelet Count Decreased (3)Myocardial Infarction (3)

Below is the selection of adverse event reports related to Zolinza (Vorinostat) that includes cases resulting in a serious event.

Adverse event in 61 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-31

Patient: 61 year old female, weighing 80.4 kg (176.9 pounds)

Adverse reactions / side effects: Prothrombin Time Shortened, Pulmonary Embolism, Activated Partial Thromboplastin Time Shortened, Thrombocytopenia, Deep Vein Thrombosis

Suspect drug(s):
Zolinza
    Dosage: 400 mg daily 21 of 28 days p.o. 30 mg daily 21 day of 28 days po
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2007-05-04
    End date: 2007-05-24

Zolinza
    Dosage: 400 mg daily 21 of 28 days p.o. 30 mg daily 21 day of 28 days po
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2007-06-01
    End date: 2007-10-24

Other drugs received by patient: Tamoxifen Citrate; Zometa; Glucosamine Chondroitin



Adverse event in 68 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-19

Patient: 68 year old female

Adverse reactions / side effects: Abdominal Discomfort, Osteonecrosis, Fatigue

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 55 year old male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-16

Patient: 55 year old male

Adverse reactions / side effects: Hypoventilation, Anaemia, Delirium, Malaise, Fungal Infection, Dehydration, Thrombocytopenia, Acute Prerenal Failure

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 60 year old male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-15

Patient: 60 year old male

Adverse reactions / side effects: Blood Creatine Phosphokinase Increased, Coagulopathy, Drug Interaction, Pyrexia, Myalgia, Nephrolithiasis, Pyelectasia, Oedema Peripheral, Muscle Spasms, Cough, Back Pain, Haemorrhage Urinary Tract, Haematuria, Anaemia, Benign Prostatic Hyperplasia, Renal Cyst, Flank Pain, Dehydration

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Coumadin
    Administration route: Oral
    End date: 2007-07-25

Lipitor
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2007-07-25

Targretin
    Administration route: Oral
    End date: 2007-07-25

Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2007-07-13
    End date: 2007-07-25

Other drugs received by patient: Paxil; Ritalin; Megace; Synthroid; Toprol-XL; Omega-3 Marine Triglycerides; Prinivil; Zantac; Hydroxyzine Hydrochloride



Adverse event in male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-05

Patient: male

Adverse reactions / side effects: Mycosis Fungoides

Adverse event resulted in: death

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 53 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-04

Patient: 53 year old female, weighing 77.0 kg (169.4 pounds)

Adverse reactions / side effects: Mucosal Inflammation, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, non-Hodgkin's Lymphoma

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: non-Hodgkin's Lymphoma
    Start date: 2007-03-14
    End date: 2007-03-19

Zolinza
    Administration route: Oral
    Start date: 2007-03-21
    End date: 2007-03-26

Zolinza
    Administration route: Oral
    Start date: 2007-04-13
    End date: 2007-04-25

Zolinza
    Administration route: Oral
    Start date: 2007-04-26
    End date: 2007-04-29

Zolinza
    Administration route: Oral
    Start date: 2007-05-02
    End date: 2007-05-14

Other drugs received by patient: Cytoxan; Nexavar; Prednisone; Buphenyl; Rituxan



Adverse event in 72 year old male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-10-03

Patient: 72 year old male

Adverse reactions / side effects: Weight Decreased, Nausea, Feeling Cold, Malaise, Fatigue, Dehydration, Anorexia, Malignant Melanoma, Dizziness

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2007-05-18
    End date: 2007-07-05

Zolinza
    Administration route: Oral
    Start date: 2007-07-05
    End date: 2007-07-21

Other drugs received by patient: Celebrex; Cyclobenzaprine Hydrochloride



Adverse event in 63 year old female receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-03

Patient: 63 year old female, weighing 76.5 kg (168.3 pounds)

Adverse reactions / side effects: Back Pain, Hypotension, Atrial Fibrillation, Dizziness, Platelet Count Decreased, Pulmonary Artery Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Zolinza (Vorinostat)

Other drugs received by patient: Tamoxifen Citrate; Compasine; Oxicodone; Aciphex



Adverse event in 50 year old male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-07-30

Patient: 50 year old male

Adverse reactions / side effects: Drug Level Increased, Drug Interaction

Suspect drug(s):
Cyclosporine

Zolinza
    Administration route: Oral
    Start date: 2007-06-01



Adverse event in 84 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-07-30

Patient: 84 year old female

Adverse reactions / side effects: Fatigue, Diarrhoea, Mycosis Fungoides, Platelet Count Decreased

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 80 year old male receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-07-25

Patient: 80 year old male

Adverse reactions / side effects: Malignant Melanoma

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 79 year old female receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-10

Patient: 79 year old female, weighing 48.0 kg (105.6 pounds)

Adverse reactions / side effects: Weight Decreased, Chest Discomfort, Dyspnoea, Vomiting, Restlessness, Nausea, Muscular Weakness, Constipation, Discomfort, Drug Toxicity, Fatigue, Flank Pain, Anorexia, Oedema Peripheral, Cold Sweat, Heart Rate Abnormal

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2007-04-10
    End date: 2007-04-15

Zolinza
    Administration route: Oral
    Start date: 2007-04-17

Zolinza
    Administration route: Oral
    Start date: 2007-04-03

Other drugs received by patient: Boniva; Digoxin; Ranitidine; Metformin; Norvasc; Lipitor; Tricor; Hydroxyzine Hydrochloride; Synthroid; Clobetasol Propionate; Triamcinolone; Fluocinolone Acetonide; Vitamin E; Ascorbic Acid; Calcium (Unspecified); Docusate Sodium; Compazine



Adverse event in 69 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-06-20

Patient: 69 year old female, weighing 70.0 kg (154.0 pounds)

Adverse reactions / side effects: Weight Decreased, Anaemia, Mycosis Fungoides, Hepatitis B Positive, Transaminases Increased, Syncope, Anorexia, Dehydration, Hepatitis A Antibody Positive, Dizziness, Transient Ischaemic Attack, Hepatitis C Positive, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2007-02-02
    End date: 2007-03-01

Zolinza
    Administration route: Oral
    Start date: 2007-05-04
    End date: 2007-05-05

Zolinza
    Administration route: Oral
    Start date: 2007-03-02
    End date: 2007-04-20

Zolinza
    Administration route: Oral
    Start date: 2006-12-22



Adverse event in 69 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-06-06

Patient: 69 year old female, weighing 70.0 kg (154.0 pounds)

Adverse reactions / side effects: Weight Decreased, Anaemia, Mycosis Fungoides, Hepatitis B Positive, Transaminases Increased, Syncope, Anorexia, Dehydration, Hepatitis A Antibody Positive, Transient Ischaemic Attack, Hepatitis C Positive, Acute Prerenal Failure

Adverse event resulted in: hospitalization

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2007-02-02
    End date: 2007-03-01

Zolinza
    Administration route: Oral
    Start date: 2007-05-04
    End date: 2007-05-05

Zolinza
    Administration route: Oral
    Start date: 2007-03-02
    End date: 2007-04-20

Zolinza
    Administration route: Oral
    Start date: 2006-12-22



Adverse event in female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-05-23

Patient: female

Adverse reactions / side effects: Mycosis Fungoides, Anorexia

Suspect drug(s):
Zolinza (Vorinostat)

Other drugs received by patient: Corticosteroids (Unspecified); [therapy Unspecified]



Adverse event in 78 year old female receiving Zolinza (Vorinostat)

Reported by a individual with unspecified qualification from United States on 2007-05-10

Patient: 78 year old female

Adverse reactions / side effects: Dysgeusia, Weight Decreased, Pruritus, Drug Ineffective, Nausea, RED Blood Cell Count Increased, Platelet Count Decreased

Suspect drug(s):
Compazine

Kytril

Zolinza
    Dosage: see image
    Administration route: Oral
    Indication: T-Cell Lymphoma
    Start date: 2006-11-30
    End date: 2007-01-19

Zolinza
    Dosage: see image
    Administration route: Oral
    Indication: T-Cell Lymphoma
    Start date: 2007-02-01

Other drugs received by patient: Levothyroxine Sodium



Adverse event in male receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-09

Patient: male

Adverse reactions / side effects: Death, Adverse Event

Adverse event resulted in: death

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 60 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-04-06

Patient: 60 year old female

Adverse reactions / side effects: Renal Failure, Diarrhoea, Dehydration, Myocardial Infarction

Adverse event resulted in: death, life threatening event, disablity

Suspect drug(s):
Zolinza
    Administration route: Oral
    Indication: Mycosis Fungoides Refractory
    Start date: 2006-11-01
    End date: 2006-01-01

Zolinza
    Administration route: Oral

Zolinza
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-12-01



Adverse event in 71 year old male receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-03-27

Patient: 71 year old male

Adverse reactions / side effects: Confusional State, Blood Potassium Decreased, Mycosis Fungoides, Pain, Pyrexia

Adverse event resulted in: hospitalization

Suspect drug(s):
Zolinza (Vorinostat)

Other drugs received by patient: Oxycodone; Temazepam; Hydrochlorothiazide and Triamterene; Bactroban; Norvasc; Bentyl; Xanax; Vitamins (Unspecified); Vistaril



Adverse event in male receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-03-13

Patient: male

Adverse reactions / side effects: Death, Thrombolysis

Adverse event resulted in: death

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in 71 year old male receiving Zolinza (Vorinostat)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-03-12

Patient: 71 year old male

Adverse reactions / side effects: Pain, Mycosis Fungoides

Suspect drug(s):
Zolinza (Vorinostat)

Other drugs received by patient: Oxycodone; Temazepam; Hydrochlorothiazide and Triamterene; Bactroban; Norvasc; Bentyl; Xanax; Vitamins (Unspecified); Vistaril



Adverse event in 60 year old female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-01-29

Patient: 60 year old female

Adverse reactions / side effects: Diarrhoea, Dehydration, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Zolinza (Vorinostat)



Adverse event in female receiving Zolinza (Vorinostat)

Reported by a physician from United States on 2007-01-11

Patient: female

Adverse reactions / side effects: Diarrhoea, Dehydration, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Zolinza (Vorinostat)

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