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 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 2012-08-23
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 2012-08-22
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 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 2012-08-15
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: Neoplasm Progression
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 2012-08-13
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: 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 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 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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