Index of reports
> All Cases (78)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zolinza (Vorinostat) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 78 Next >>
Possible Zolinza side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-27
Patient:
Reactions: Dermatitis Acneiform, Dysgeusia, Malaise, Folliculitis, Platelet Count Decreased, Decreased Appetite, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg, qd
Administration route: Oral
Indication: Anaplastic Large Cell Lymphoma T- and Null-Cell Types
Start date: 2011-11-21
End date: 2011-12-05
Zolinza
Dosage: 300 mg, unk
Administration route: Oral
Start date: 2011-12-14
Other drugs received by patient: Loxoprofen; Lansoprazole; Lyrica; Vitamin B12; Mucosta
Possible Zolinza side effects in
Reported by a physician from United States on 2012-08-27
Patient:
Reactions: Diarrhoea, Medication Residue
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Protonix; Cholecalciferol; Fatty Acids (Unspecified); Dexamethasone; Quest Once A DAY Multiple Vitamins and Minerals
Possible Zolinza side effects in
Reported by a consumer/non-health professional from Japan on 2012-08-23
Patient:
Reactions: Vomiting, Nausea, Alanine Aminotransferase Increased, Eosinophilic Pneumonia Acute, Parotitis, Constipation, Death, Aspartate Aminotransferase Increased, Platelet Count Decreased, Pleural Effusion, Deep Vein Thrombosis, Decreased Appetite
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg, qd
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2011-11-10
End date: 2011-11-21
Zolinza
Dosage: 300 mg, qd
Administration route: Oral
Start date: 2012-01-02
End date: 2012-01-14
Zolinza
Dosage: 300 mg, qd
Administration route: Oral
Start date: 2011-11-29
End date: 2011-12-01
Zolinza
Dosage: 300 mg, qd
Administration route: Oral
Start date: 2011-12-08
End date: 2011-12-26
Other drugs received by patient: Pantethine; Allegra; Armodafinil; Maglax (Magnesium Oxide); Lantus; Rabeprazole Sodium; Novorapid; Lipitor
Possible Zolinza side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Ammonia Increased, Convulsion, Blood Test Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Decitabine
Dosage: 15 mg per kg
Indication: Acute Leukaemia
Zolinza
Dosage: 180 mg, daily for 1 week on and 1 week off
Administration route: Oral
Indication: Acute Leukaemia
Possible Zolinza side effects in
Reported by a consumer/non-health professional from Japan on 2012-08-23
Patient:
Reactions: Renal Failure, Malaise, Dehydration, Pyrexia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Epinastine Hydrochloride; Periactin; Epinazion; Azucurenin S
Possible Zolinza side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: White Blood Cell Count Decreased, Febrile Neutropenia, Platelet Count Decreased, Neutrophil Count Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Temozolomide
Dosage: 75 mg/m2, qd
Administration route: Oral
Start date: 2012-07-23
End date: 2012-07-30
Temozolomide
Dosage: 75 mg/m2, qd
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-02
Zolinza
Dosage: 300 mg, on days 1-5, qw
Administration route: Oral
Start date: 2012-07-23
End date: 2012-07-30
Zolinza
Dosage: 300 mg, on days 1-5, qw
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-02
Possible Zolinza side effects in
Reported by a physician from Japan on 2012-08-23
Patient:
Reactions: Ileus, Arrhythmia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-02-17
End date: 2012-02-21
Zolinza
Administration route: Oral
Start date: 2012-03-09
End date: 2012-04-13
Zolinza
Administration route: Oral
Start date: 2012-03-09
End date: 2012-04-13
Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Slow-K; Maxipime; Omeprazole; Pletal; [therapy Unspecified]; Januvia; Firstcin; Firstcin; Maxipime; Funguard; Verapamil HCL; Januvia; Itraconazole; Candesartan Cilexetil; Epinastine Hydrochloride; Firstcin; Adona; Pletal; Epinastine Hydrochloride; Aldactone; Pletal; Pletal; DAI-Kenchu-TO; Sulfamethoxazole and Trimethoprim; Omeprazole; Candesartan Cilexetil; Firstcin; Maxipime; Omeprazole; Maxipime; Zosyn
Possible Zolinza side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Abdominal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 230 mg/m2, qd, cycle = 28 days (max = 12 cycle)
Administration route: Oral
Start date: 2012-06-30
End date: 2012-07-05
Zolinza
Dosage: 230 mg/m2, qd, cycle = 28 days (max = 12 cycle)
Administration route: Oral
Start date: 2012-06-08
End date: 2012-06-28
Zolinza
Dosage: 230 mg/m2, on days 1-5 weekly, cycle = 6 weeks
Administration route: Oral
Indication: Brain Stem Glioma
Start date: 2012-04-02
Possible Zolinza side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient:
Reactions: Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Temozolomide
Dosage: 75 mg/m2, qd
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-16
End date: 2012-08-02
Zolinza
Dosage: 300 mg, on days 1-5 weekly
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-16
End date: 2012-08-02
Possible Zolinza side effects in
Reported by a physician from United States on 2012-08-15
Patient:
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Hexadrol
Administration route: Oral
Zolinza
Dosage: 230 mg/m2, qd
Administration route: Oral
Indication: Brain Stem Glioma
Start date: 2012-06-25
Other drugs received by patient: Zofran; Albuterol
Possible Zolinza side effects in
Reported by a individual with unspecified qualification from United States on 2012-08-15
Patient:
Reactions: NO Adverse Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Temozolomide
Dosage: 75 mg/m2, qd
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-06-04
End date: 2012-06-27
Zolinza
Dosage: 300 mg, on days 1-5 weekly,
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-06-04
End date: 2012-06-27
Possible Zolinza side effects in
Reported by a physician from United States on 2012-08-10
Patient:
Reactions: Abdominal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 230 mg/m2, qd, cycle = 28 days (max = 12 cycle)
Administration route: Oral
Start date: 2012-06-08
End date: 2012-06-28
Zolinza
Dosage: 230 mg/m2, qd, cycle = 28 days (max = 12 cycle)
Administration route: Oral
Start date: 2012-06-30
End date: 2012-07-05
Zolinza
Dosage: 230 mg/m2, on days 1-5 weekly, cycle = 6 weeks
Administration route: Oral
Indication: Brain Stem Glioma
Start date: 2012-04-02
Possible Zolinza side effects in
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient:
Reactions: Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Temozolomide
Dosage: 75 mg/m2, qd
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-16
End date: 2012-08-02
Zolinza
Dosage: 300 mg, on days 1-5 weekly
Administration route: Oral
Indication: Glioblastoma Multiforme
Start date: 2012-07-16
End date: 2012-08-02
Possible Zolinza side effects in
Reported by a physician from Japan on 2012-07-31
Patient:
Reactions: Nausea, Bone Marrow Failure
Drug(s) suspected as cause:
Zolinza
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2011-11-01
End date: 2011-11-04
Zolinza
Administration route: Oral
Start date: 2011-11-10
End date: 2011-11-16
Other drugs received by patient: Dexamethasone Sodium Phosphate; Paraplatin AQ; Ifosfamide; Lansoprazole; Vfend; Miya BM; Itraconazole; Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Daiphen; Irinotecan Hydrochloride; Fildesin; Dexamethasone Sodium Phosphate; Magmitt
Possible Zolinza side effects in
Reported by a physician from Japan on 2012-07-26
Patient:
Reactions: Renal Disorder, Urine Output Decreased, Pyrexia, Altered State of Consciousness, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zolinza
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-04-11
End date: 2012-04-14
Zolinza
Administration route: Oral
Start date: 2012-05-09
End date: 2012-05-10
Zolinza
Zolinza
Indication: Peripheral T-Cell Lymphoma Unspecified
Other drugs received by patient: Famotidine; Zolpidem; Norvasc; Prednisolone; Diflucan; Lasix; Magmitt; Pursennid (Sennosides)
Possible Zolinza side effects in
Reported by a physician from Japan on 2012-07-12
Patient:
Reactions: Renal Failure Acute, Pyelonephritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Prednisolone; Prednisolone; Alendronate Sodium; Levothyroxine Sodium; Olmesartan Medoxomil; Lansoprazole; Olopatadine HCL; Amlodipine Besylate
Possible Zolinza side effects in
Reported by a physician from Japan on 2012-07-09
Patient:
Reactions: Diarrhoea, Dehydration, Blood Pressure Decreased, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg, qd
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-04-03
End date: 2012-04-13
Zolinza
Dosage: 300 mg, qd
Administration route: Oral
Start date: 2012-04-14
End date: 2012-04-20
Other drugs received by patient: Rocephin; Levofloxacin; Celestamine TAB; Itraconazole; Pepcidine; Allegra
Possible Zolinza side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26
Patient: 52 year old female, weighing 103.5 kg (227.7 pounds)
Reactions: Confusional State, Atelectasis, Haemorrhage Intracranial, Multi-Organ Failure, Respiratory Failure, Sepsis, Colitis, Hypoxia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Gemtuzumab
Dosage: 3 milligram/sq. meter
Start date: 2012-02-10
End date: 2012-02-17
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2012-02-10
End date: 2012-02-16
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2012-02-10
End date: 2012-02-16
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2012-02-10
End date: 2012-02-18
Other drugs received by patient: Ribavirin; Steroids
Possible Zolinza side effects in 49 year old female
Reported by a individual with unspecified qualification from Japan on 2012-06-22
Patient: 49 year old female
Reactions: Diarrhoea, Dehydration, Blood Pressure Decreased, Hypokalaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Itraconazole; Levofloxacin; Allegra; Pepcid RPD; Rocephin; Celestamine (Betamethasone (+) Dexchlorp
Possible Zolinza side effects in 48 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22
Patient: 48 year old male
Reactions: Syncope, Orthostatic Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lenalidomide
Dosage: 25 mg/daily
Indication: Multiple Myeloma
Zolinza
Dosage: 400 mg/po
Administration route: Oral
Indication: Multiple Myeloma
Possible Zolinza side effects in 38 year old female
Reported by a consumer/non-health professional from Canada on 2012-06-22
Patient: 38 year old female
Reactions: Cellulitis, Laceration, Immune System Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolinza
Dosage: two weeks on two weeks off
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2012-05-20
Zolinza
Dosage: two weeks on two weeks off
Administration route: Oral
Start date: 2012-05-01
Zolinza
Dosage: two weeks on two weeks off
Administration route: Oral
Start date: 2012-05-27
Possible Zolinza side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 58 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Phenergan HCL; Haldol; Morphine; Roxanol
Possible Zolinza side effects in 51 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 51 year old male, weighing 50.0 kg (110.0 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Docusate Sodium and Sennosides; Acetaminophen and Hydrocodone Bitartrate; Alprazolam
Possible Zolinza side effects in 68 year old female
Reported by a individual with unspecified qualification from Japan on 2012-06-20
Patient: 68 year old female
Reactions: Dysgeusia, Hepatic Function Abnormal, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Hypercreatinaemia
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg/daily, po; 300mg/daily, po; 400 mg/daily, po; 300 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-01-13
End date: 2012-01-19
Zolinza
Dosage: 400 mg/daily, po; 300mg/daily, po; 400 mg/daily, po; 300 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-02-10
End date: 2012-02-23
Zolinza
Dosage: 400 mg/daily, po; 300mg/daily, po; 400 mg/daily, po; 300 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-01-05
End date: 2012-01-12
Zolinza
Dosage: 400 mg/daily, po; 300mg/daily, po; 400 mg/daily, po; 300 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-01-20
End date: 2012-02-09
Possible Zolinza side effects in 70 year old female
Reported by a individual with unspecified qualification from Japan on 2012-06-12
Patient: 70 year old female
Reactions: Respiratory Disorder, Anaemia, Platelet Count Decreased, Renal Failure Acute, Pyelonephritis, White Blood Cell Count Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Zolinza
Other drugs received by patient: Olmetec; Lansoprazole; Fosamax; Amlodipine Besylate; Olopatadine HCL; Predonine; Levothyroxine Sodium
Possible Zolinza side effects in 56 year old female
Reported by a physician from United States on 2012-06-11
Patient: 56 year old female, weighing 60.9 kg (133.9 pounds)
Reactions: Acute Myeloid Leukaemia, Supraventricular Tachycardia, Pneumothorax, Pyrexia, Pneumonitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-11-10
End date: 2011-11-10
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-11-07
End date: 2011-11-13
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-11-07
End date: 2011-11-13
Other drugs received by patient: Metoprolol Tartrate; Oxycodone HCL; Docusate; Ipratropium Bromide; Metoclopramide; Vitamin D; Lanolin; Benadryl; Benadryl; Senna-Mint WAF; Fluconazole; Levofloxacin; Omeprazole; Aluminum-Magnesium-Simethicone; Prochlorperazine; Zofran; Acyclovir; Ascorbic Acid; Hypromellose; Loperamide; Lorazepam; Magnesium Hydroxide TAB; Dalteparin Sodium; Acetaminophen; Lorazepam; Magnesium Citrate; Multi-Vitamins; Miralax; Albuterol; Chlorhexidine Gluconate; Prednisone TAB; Morphine; Eucerin
Possible Zolinza side effects in 80 year old male
Reported by a individual with unspecified qualification from Australia on 2012-06-05
Patient: 80 year old male
Reactions: Mycosis Fungoides, Disease Progression
Drug(s) suspected as cause:
Zolinza
Possible Zolinza side effects in female
Reported by a physician from United States on 2012-06-04
Patient: female, weighing 64.9 kg (142.8 pounds)
Reactions: White Blood Cell Count Decreased, Pneumonia, Febrile Neutropenia, Disease Progression, Cardiac Failure, Injection Site Reaction, Sepsis, Pleural Effusion, Neutrophil Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-11
Mylotarg
Dosage: 5.1 milligram
Start date: 2011-11-07
End date: 2011-11-11
Vidaza
Dosage: 125 milligram/sq. meter
Start date: 2011-11-04
End date: 2011-11-10
Vidaza
Dosage: 75 milligram/sq. meter
Start date: 2011-10-04
End date: 2011-10-10
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-11-04
End date: 2011-11-12
Zolinza
Dosage: 400 milligram
Administration route: Oral
Start date: 2011-10-04
End date: 2011-10-12
Other drugs received by patient: Levothyroxine Sodium; Diphenhydramine HCL; Lipitor; Hydrocodone
Possible Zolinza side effects in 80 year old
Reported by a physician from Australia on 2012-06-04
Patient: 80 year old
Reactions: Disease Progression
Drug(s) suspected as cause:
Zolinza
Possible Zolinza side effects in 68 year old male
Reported by a individual with unspecified qualification from Japan on 2012-06-01
Patient: 68 year old male
Reactions: Mycosis Fungoides, Condition Aggravated, Lymphocyte Morphology Abnormal, Haemolytic Anaemia, Thrombocytopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Zolinza
Dosage: 400 mg/daily, po, 300 mg/daily, 200 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2012-02-10
End date: 2012-02-24
Zolinza
Dosage: 400 mg/daily, po, 300 mg/daily, 200 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2011-12-27
End date: 2012-02-09
Zolinza
Dosage: 400 mg/daily, po, 300 mg/daily, 200 mg/daily, po
Administration route: Oral
Indication: Mycosis Fungoides
Start date: 2011-11-22
End date: 2011-12-26
Other drugs received by patient: Tigason; Coniel; Tamsulosin HCL; Prinivil
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