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Zolinza (Vorinostat) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zolinza (Vorinostat) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (78)
Death (22)
Life Threatening Events (20)
Disability (2)

Reports by Reaction Type

Pyrexia (15)Decreased Appetite (12)Dehydration (10)Pneumonitis (9)Pleural Effusion (8)Febrile Neutropenia (8)Sepsis (8)Disease Progression (6)White Blood Cell Count Decreased (6)Renal Failure (6)Diarrhoea (6)Platelet Count Decreased (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Zolinza (Vorinostat). For a complete list or a specific selection of reports, please use the links above.

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 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 2012-08-23

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 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 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 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 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 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 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 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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