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Doxil (Doxorubicin) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (9)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Doxil (Doxorubicin) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Doxil side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female, weighing 70.8 kg (155.8 pounds)

Reactions: Abdominal Pain, Hyperpyrexia, Anaphylactic Reaction, Chills, Pain, Hepatic Failure, Transaminases Increased, Splenic Infarction, Loss of Consciousness, Aortic Thrombosis, Off Label Use, Malaise, C-Reactive Protein Increased, Myositis, Dyspnoea, Hypotension, Arrhythmia, Lung Consolidation, Hypophosphataemia, Zygomycosis, Bacteraemia, Ventricular Tachycardia, Hyperammonaemia, Neutropenia, Hepatic Infarction, Shock, Infusion Related Reaction

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vincristine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Decadron Phosphate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Velcade
    Dosage: day 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Cytarabine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Methotrexate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2005-01-01
    End date: 2007-01-01

PEG-Asparaginase
    Dosage: day 2, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-25
    End date: 2007-10-25

Doxil
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23



Possible Doxil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Off Label Use, Uterine Cancer, Nausea, Intestinal Obstruction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in 65 year old female

Reported by a physician from United States on 2012-06-06

Patient: 65 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Hospitalisation, Angiosarcoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil

Other drugs received by patient: Blood Thinners; Cardiac Medications



Possible Doxil side effects in 57 year old female

Reported by a physician from United States on 2012-05-04

Patient: 57 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Hospitalisation, Angiosarcoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil

Other drugs received by patient: Cardiac Medications; Blood Thinners



Possible Doxil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-01

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Thrombosis, Diverticulitis, Haemorrhoids, Intestinal Obstruction, Metastasis, Off Label Use, Uterine Cancer, Pleural Effusion, Haematoma, Fluid Retention

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil
    Indication: Uterine Cancer
    Start date: 2011-05-18
    End date: 2011-06-15

Doxil
    Start date: 2011-07-13
    End date: 2011-08-10

Doxil
    Start date: 2011-09-07
    End date: 2011-10-05

Other drugs received by patient: Prevacid; Ondansetron HCL; Benadryl; Prevacid; Reglan; Methadone HCL; Decadron; Coumadin; Dilaudid; Fentanyl Citrate



Possible Doxil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-21

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Thrombosis, Haemorrhoids, Diverticulitis, Intestinal Obstruction, Metastasis, Off Label Use, Uterine Cancer, Pleural Effusion, Fluid Retention, Haematoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil

Other drugs received by patient: Prevacid; Coumadin; Zofran; Prevacid; Dilaudid; Fentanyl; Reglan; Methadone HCL; Decadron; Benadryl



Possible Doxil side effects in female

Reported by a physician from Japan on 2011-11-28

Patient: female

Reactions: Off Label Use, Blood Pressure Increased, Dyspnoea, Palpitations, Chest Pain, Infusion Site Reaction

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in male

Reported by a physician from United States on 2011-11-28

Patient: male

Reactions: Off Label Use, Disease Progression

Drug(s) suspected as cause:
Doxil
    Indication: Liposarcoma
    Start date: 2010-12-01
    End date: 2011-06-01

Doxil
    Start date: 2007-01-01

Afinitor
    Indication: Liposarcoma



Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-09

Patient: female, weighing 108.9 kg (239.5 pounds)

Reactions: Drug Dose Omission, Off Label Use, Skin Disorder, Headache

Drug(s) suspected as cause:
Doxil
    Indication: Vaginal Cancer
    Start date: 2010-09-01

Doxil
    Indication: Bladder Cancer
    Start date: 2010-09-01

Doxil
    Indication: Angiosarcoma
    Start date: 2010-09-01

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