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Leustatin (Cladribine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Leustatin (Cladribine) 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 (9)
Death (1)
Disability (2)

Reports by Reaction Type

Blood Creatinine Increased (5)Rash (5)Drug Ineffective (3)Chills (3)Pyrexia (3)Myalgia (3)Liver Function Test Abnormal (3)Pancytopenia (3)Tremor (3)Flushing (3)Feeling Abnormal (3)Hospitalisation (2)

Possible Leustatin side effects in

Reported by a physician from Greece on 2012-05-24

Patient:

Reactions: Glioblastoma, Lung Adenocarcinoma

Drug(s) suspected as cause:
Leustatin



Possible Leustatin side effects in

Reported by a physician from Greece on 2012-05-15

Patient:

Reactions: Glioblastoma, Lung Adenocarcinoma

Drug(s) suspected as cause:
Leustatin



Possible Leustatin side effects in 45 year old female

Reported by a physician from Uruguay on 2012-04-09

Patient: 45 year old female

Reactions: Hospitalisation, Rash, Blood Creatinine Increased, Transaminases Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leustatin



Possible Leustatin side effects in male

Reported by a physician from United States on 2012-02-28

Patient: male, weighing 91.5 kg (201.2 pounds)

Reactions: Drug Ineffective, Chills, Pancytopenia, Rash, Pyrexia, Tremor, Flushing, Myalgia, Liver Function Test Abnormal, Blood Creatinine Increased, Feeling Abnormal

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Bactrim
    Indication: Pyrexia
    Start date: 2011-12-28
    End date: 2012-01-05

Levofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-05

Bactrim
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2011-12-28
    End date: 2012-01-05

Rocephin
    Indication: Pyrexia
    Start date: 2012-01-05
    End date: 2012-01-05

Acyclovir
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2011-12-28
    End date: 2012-01-10

Leustatin
    Dosage: for 7 days
    Indication: Hairy Cell Leukaemia
    Start date: 2011-12-28
    End date: 2012-01-04

Other drugs received by patient: Lovastatin; Allopurinol; Vicodin



Possible Leustatin side effects in male

Reported by a physician from United States on 2012-02-03

Patient: male, weighing 97.1 kg (213.6 pounds)

Reactions: Drug Ineffective, Chills, Pancytopenia, Pyrexia, Rash, Tremor, Flushing, Myalgia, Liver Function Test Abnormal, Blood Creatinine Increased, Feeling Abnormal

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Acyclovir
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2011-12-28
    End date: 2012-01-10

Levofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-05

Bactrim
    Indication: Pyrexia
    Start date: 2011-12-28
    End date: 2012-01-05

Rocephin
    Indication: Pyrexia
    Start date: 2012-01-05
    End date: 2012-01-05

Leustatin
    Dosage: for 7 days
    Indication: Hairy Cell Leukaemia
    Start date: 2011-12-28
    End date: 2012-01-05

Bactrim
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2011-12-28
    End date: 2012-01-05

Other drugs received by patient: Lovastatin; Vicodin; Allopurinol



Possible Leustatin side effects in 57 year old female

Reported by a physician from Japan on 2012-01-31

Patient: 57 year old female

Reactions: Pneumonia, Haemoptysis, Anaemia, Neutropenia, Acute Respiratory Failure, Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Indication: non-Hodgkin's Lymphoma

Leustatin
    Indication: non-Hodgkin's Lymphoma
    Start date: 2006-01-01

Rituximab
    Indication: non-Hodgkin's Lymphoma
    Start date: 2006-01-01

Daunorubicin HCL
    Indication: non-Hodgkin's Lymphoma

Cytarabine
    Indication: non-Hodgkin's Lymphoma

Etoposide
    Indication: non-Hodgkin's Lymphoma

Cyclophosphamide
    Indication: non-Hodgkin's Lymphoma

Vincristine
    Indication: non-Hodgkin's Lymphoma

Prednisolone
    Indication: non-Hodgkin's Lymphoma

Other drugs received by patient: Fluconazole; Micafungin; Doripenem; Cotrim



Possible Leustatin side effects in 45 year old female

Reported by a physician from Uruguay on 2012-01-25

Patient: 45 year old female

Reactions: Hospitalisation, Rash, Blood Creatinine Increased, Transaminases Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leustatin



Possible Leustatin side effects in 55 year old male

Reported by a physician from United States on 2012-01-13

Patient: 55 year old male

Reactions: Drug Ineffective, Chills, Pancytopenia, Rash, Pyrexia, Tremor, Flushing, Myalgia, Liver Function Test Abnormal, Blood Creatinine Increased, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leustatin
    Dosage: for 7 days
    Indication: Hairy Cell Leukaemia
    Start date: 2011-12-28
    End date: 2012-01-04

Levofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-05

Rocephin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Allopurinol; Bactrim; Acyclovir; Lovastatin



Possible Leustatin side effects in female

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

Patient: female, weighing 88.9 kg (195.6 pounds)

Reactions: Mixed Oligo-Astrocytoma

Drug(s) suspected as cause:
Leustatin

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