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Zolinza (Vorinostat) - Pleural Effusion - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Pleural Effusion (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zolinza (Vorinostat) where reactions include pleural effusion. The selected reports were submitted to the FDA during the sample period of about a year.

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 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:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-04
    End date: 2011-11-12

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: 2011-10-04
    End date: 2011-10-12

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

Other drugs received by patient: Levothyroxine Sodium; Diphenhydramine HCL; Lipitor; Hydrocodone



Possible Zolinza side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-16

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Pneumonia, Cardiac Failure, Injection Site Reaction, Pleural Effusion, Febrile Neutropenia, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-11

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-04
    End date: 2011-11-12

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-10

Mylotarg
    End date: 2011-11-11

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-10-04
    End date: 2011-10-12

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-04

Other drugs received by patient: Hydrocodone; Lipitor; Diphenhydramine HCL; Levothyroxine Sodium



Possible Zolinza side effects in 63 year old female

Reported by a physician from Japan on 2012-03-19

Patient: 63 year old female

Reactions: Vomiting, Nausea, Alanine Aminotransferase Increased, General Physical Health Deterioration, Eosinophilic Pneumonia Acute, Parotitis, Constipation, Aspartate Aminotransferase Increased, Pleural Effusion, Decreased Appetite, Deep Vein Thrombosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 mg/daily 300 mg/daily
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-11-10
    End date: 2011-11-21

Zolinza
    Dosage: 400 mg/daily 300 mg/daily
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-11-29
    End date: 2011-12-01

Zolinza
    Dosage: 400 mg/daily 300 mg/daily
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2012-01-02
    End date: 2012-01-14

Zolinza
    Dosage: 400 mg/daily 300 mg/daily
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-12-08
    End date: 2011-12-26

Other drugs received by patient: Pantethine; Lipitor; Lantus; Allegra; Diflucan; Novorapid; Rabeprazole Sodium; Maglax (Magnesium Oxide)



Possible Zolinza side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-11

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: 2011-10-04
    End date: 2011-10-12

Other drugs received by patient: Levothyroxine Sodium; Lipitor; Diphenhydramine HCL; Hydrocodone



Possible Zolinza side effects in 63 year old female

Reported by a individual with unspecified qualification from Japan on 2012-02-23

Patient: 63 year old female

Reactions: Interstitial Lung Disease, Pleural Effusion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza



Possible Zolinza side effects in 66 year old female

Reported by a physician from United States on 2012-01-26

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 mg, on days 1-9
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-12

Mylotarg
    Dosage: 3 mg/m2, on days 4 and 8
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-11

Vidaza
    Dosage: 75 mg/m2, on days 1-7
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-10

Other drugs received by patient: Hydrocodone; Lipitor; Benadryl; Levothyroxine Sodium



Possible Zolinza side effects in 66 year old female

Reported by a physician from United States on 2011-11-23

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azacitidine
    Dosage: 75 mg/m2/day, sc or iv on days 1-7 (total dose this course: 896mg)
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-10

Zolinza
    Dosage: 400 mg, 1x/day on days 1-9 (total dose this course: 3600mg)
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-12

Mylotarg
    Dosage: 3 mg/m2, over 2 hrs on days 4 and 8 (total dose this course: 10.2mg)
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-11

Other drugs received by patient: Levothyroxine Sodium; Benadryl; Hydrocodone; Lipitor

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