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Temodar (Temozolomide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Temodar (Temozolomide) 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 (141)
Death (33)
Life Threatening Events (23)
Disability (5)

Reports by Reaction Type

Death (18)Platelet Count Decreased (17)Chills (8)Disease Progression (8)Vomiting (8)Nausea (8)Pancytopenia (8)Neoplasm Progression (7)Constipation (7)Fall (7)Pyrexia (6)Fatigue (6)

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

Possible Temodar side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-25

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Bevacizumab



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Overdose, NO Adverse Event

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Post Procedural Infection

Drug(s) suspected as cause:
Temodar
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: Brain Neoplasm
    Start date: 2012-07-19

Temodar
    Dosage: 150 mg, qd
    Administration route: Oral
    Start date: 2012-07-19

Temodar
    Dosage: 150 mg, qd
    Administration route: Oral
    Start date: 2012-07-19

Temodar
    Dosage: 150 mg, qd
    Administration route: Oral
    Start date: 2012-07-19



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in female

Reported by a pharmacist from United States on 2012-08-23

Patient: female

Reactions: Fatigue, Somnolence

Drug(s) suspected as cause:
Promethazine
    Dosage: 25mg hs and q6hprn po
    Administration route: Oral
    Indication: Metastases To Lung

Temodar
    Dosage: 240mg hs for 5 days po
    Administration route: Oral
    Indication: Malignant Melanoma
    Start date: 2012-07-30
    End date: 2012-08-21



Possible Temodar side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Liver Function Test Abnormal

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Disease Progression

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Bevacizumab



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Treatment Noncompliance, Nervousness

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Thalomid



Possible Temodar side effects in 64 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 64 year old female

Reactions: Bradycardia

Drug(s) suspected as cause:
Temodar
    Dosage: 100mg daily po
    Administration route: Oral
    Start date: 2012-01-25

Temodar
    Dosage: 140mg daily po
    Administration route: Oral
    Start date: 2012-01-26



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Myalgia, TIC

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Dexilant; Effexor; Kytril



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient:

Reactions: Skin Exfoliation, Skin Burning Sensation

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Mental Status Changes, Nephrogenic Diabetes Insipidus

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Temodar
    Dosage: 150 mg/m2, unk

Temodar
    Dosage: 75 mg/m2, concomitantly with radiation
    Indication: Brain Neoplasm

Other drugs received by patient: Atorvastatin; Lopressor; Keppra



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient:

Reactions: Wound Infection, Headache, Vascular Access Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05

Vorinostat-Mycosis Fungoides
    Dosage: 300 mg, on days 1- 5,weekly
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Disease Progression

Drug(s) suspected as cause:
Bevacizumab
    Indication: Glioblastoma Multiforme

Temodar
    Indication: Glioblastoma Multiforme



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: White Blood Cell Count Decreased, Diarrhoea, Platelet Count Decreased, Mucosal Infection, Neutrophil Count Decreased, Lymphocyte Count Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Temodar
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-04-16

Vorinostat-Mycosis Fungoides
    Dosage: 300 mg, on days 1-5, weekly
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-04-16
    End date: 2012-05-17



Possible Temodar side effects in

Reported by a physician from China on 2012-08-10

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Neoplasm Progression

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Headache, Wound Infection, Vascular Access Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05

Vorinostat-Mycosis Fungoides
    Dosage: 300 mg, on days 1- 5,weekly
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05



Possible Temodar side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 59 year old female, weighing 67.1 kg (147.7 pounds)

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Disease Progression

Drug(s) suspected as cause:
Bevacizumab
    Dosage: 10 mg/kg, every 2 weeks
    Indication: Glioblastoma Multiforme

Temodar
    Dosage: 75 mg/m2, qd

Temodar
    Dosage: unk
    Indication: Glioblastoma Multiforme



Possible Temodar side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Mental Status Changes, Nephrogenic Diabetes Insipidus

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Atorvastatin; Keppra; Lopressor



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient:

Reactions: Disease Recurrence, Impaired Work Ability, Unevaluable Event

Drug(s) suspected as cause:
Temodar
    Dosage: 250 mg, x 5 days on monthly basis
    Start date: 2011-02-01

Temodar
    Dosage: 250 mg, x 5 days on monthly basis
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2001-01-01

Other drugs received by patient: Kytril; Xanax



Possible Temodar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Headache, Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05

Vorinostat-Mycosis Fungoides
    Dosage: 300 mg, on days 1- 5,weekly
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2012-06-05



Possible Temodar side effects in

Reported by a pharmacist from United States on 2012-08-02

Patient:

Reactions: Dysphagia, Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Temodar



Possible Temodar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient:

Reactions: Urinary Retention, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temodar

Other drugs received by patient: Kytril

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