This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Doxil (Doxorubicin) 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 (115)
Death (54)
Life Threatening Events (15)
Disability (4)
Reports by Reaction Type
Death (19),
Asthenia (14),
Nausea (12),
Failure To Thrive (10),
Interstitial Lung Disease (10),
Dyspnoea (10),
Sepsis (10),
Ovarian Cancer Recurrent (9),
Off Label Use (9),
Pancytopenia (9),
Multiple Myeloma (8),
Vomiting (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Doxil (Doxorubicin). For a complete list or a specific selection of reports, please use the links above.
Possible Doxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Carbohydrate Antigen 125 Increased
Drug(s) suspected as cause:
Doxil
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
Reported by a physician from Korea, Republic of on 2012-07-30
Patient:
Reactions: Blood Bilirubin Increased, Hepatic Function Abnormal, Transaminases Increased, Disease Progression
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Doxil
Dosage: 50 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Velcade
Dosage: 1.60 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Prednisone
Dosage: 100 mg, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-26
Vincristine
Dosage: 1.4 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Cyclophosphamide
Dosage: 750 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Possible Doxil side effects in
Reported by a physician from Korea, Republic of on 2012-07-24
Patient:
Reactions: Blood Bilirubin Increased, Hepatic Function Abnormal, Transaminases Increased, Disease Progression
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 750 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Velcade
Dosage: 1.60 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Vincristine
Dosage: 1.4 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Doxil
Dosage: 50 mg/m2, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-22
Prednisone
Dosage: 100 mg, unk
Indication: T-Cell Lymphoma
Start date: 2008-01-24
End date: 2008-02-26
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
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient:
Reactions: Pancreatitis Acute, Abdominal Pain, Drug Interaction, Death, Abdominal Distension, Thrombocytopenia, Cardiac Failure Congestive, Stomatitis, Nausea, Palmar-Plantar Erythrodysaesthesia Syndrome, Odynophagia, Breast Cancer Metastatic, Osteonecrosis, Pancreatitis, Neutropenia, Hypertension
Adverse event resulted in: death
Drug(s) suspected as cause:
Doxil
Other drugs received by patient possibly interacting with the suspect drug: Bevacizumab
Indication: Breast Cancer Metastatic
Carboplatin
Indication: Breast Cancer Metastatic
Other drugs received by patient: Unknown Medication
Possible Doxil side effects in female
Reported by a physician from United States on 2012-07-18
Patient: female
Reactions: Hypersensitivity, Immunology Test Abnormal
Drug(s) suspected as cause:
Doxil
Dosage: over 1 hour, every 4 weeks
Indication: Neoplasm Malignant
Placebo
Dosage: the first morning before the pld infusion and twice daily thereafter
Administration route: Oral
Indication: Prophylaxis
Possible Doxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female
Reactions: Neuropathy Peripheral, Sensation of Heaviness
Drug(s) suspected as cause:
Doxil
Possible Doxil side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-06
Patient: 49 year old female
Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Carboplatin
Dosage: 1df=auc5 also auc4
Indication: Peritoneal Carcinoma Metastatic
Cytarabine
Indication: Peritoneal Carcinoma Metastatic
Methotrexate
Indication: Peritoneal Carcinoma Metastatic
Mitomycin
Dosage: inj
Indication: Peritoneal Carcinoma Metastatic
Cyclophosphamide
Dosage: cyclophosphamide hydrate day1 also 600mg/m2
Indication: Peritoneal Carcinoma Metastatic
Prednisolone
Indication: Peritoneal Carcinoma Metastatic
Doxil
Indication: Peritoneal Carcinoma Metastatic
Irinotecan HCL
Dosage: on day 1, 15
Indication: Peritoneal Carcinoma Metastatic
Epirubicin Hydrochloride
Dosage: day1
Indication: Peritoneal Carcinoma Metastatic
Nedaplatin
Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
Indication: Peritoneal Carcinoma Metastatic
Paclitaxel
Indication: Peritoneal Carcinoma Metastatic
Docetaxel
Indication: Peritoneal Carcinoma Metastatic
Possible Doxil side effects in
Reported by a physician from United States on 2012-07-06
Patient:
Reactions: Stomatitis, Hepatic Failure, Palmar-Plantar Erythrodysaesthesia Syndrome, Febrile Neutropenia, Haematotoxicity, Cardiac Disorder, Neutropenia, Thrombocytopenia, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Indication: Diffuse Large B-Cell Lymphoma
Neulasta
Dosage: on day 2 of a 14 day cycle
Indication: Diffuse Large B-Cell Lymphoma
Prednisone TAB
Dosage: day 1-5
Administration route: Oral
Indication: Diffuse Large B-Cell Lymphoma
Vincristine
Dosage: 2 mg max
Indication: Diffuse Large B-Cell Lymphoma
Rituximab
Dosage: on day 1
Indication: Diffuse Large B-Cell Lymphoma
Doxil
Dosage: cohort 1: 20 mg/m2 cohort ii: 25 mg/m2 cohort iii: 30 mg/m2
Indication: Diffuse Large B-Cell Lymphoma
Possible Doxil side effects in
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Doxil
Possible Doxil side effects in female
Reported by a physician from Japan on 2012-07-02
Patient: female
Reactions: Nausea, Cystitis Haemorrhagic, Bone Marrow Failure
Drug(s) suspected as cause:
Ifosfamide
Dosage: day 1 to 5, total 10 cycles
Indication: Phyllodes Tumour
Doxil
Dosage: doxorubicin hydrochloride was included after cycle 2 until cycle 5
Indication: Phyllodes Tumour
Possible Doxil side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27
Patient:
Reactions: Hepatic Failure, Cardiac Disorder, Renal Failure Acute, Haematotoxicity
Adverse event resulted in: death
Drug(s) suspected as cause:
Vincristine
Dosage: 2 mg max
Indication: Diffuse Large B-Cell Lymphoma
Doxil
Dosage: cohort 1: 20 mg/m2 cohort ii: 25 mg/m2 cohort iii: 30 mg/m2
Indication: Diffuse Large B-Cell Lymphoma
Neulasta
Dosage: on day 2 of a 14 day cycle
Indication: Diffuse Large B-Cell Lymphoma
Rituximab
Dosage: on day 1
Indication: Diffuse Large B-Cell Lymphoma
Cyclophosphamide
Indication: Diffuse Large B-Cell Lymphoma
Prednisone TAB
Dosage: day 1-5
Administration route: Oral
Indication: Diffuse Large B-Cell Lymphoma
Possible Doxil side effects in 49 year old female
Reported by a consumer/non-health professional from Japan on 2012-06-25
Patient: 49 year old female
Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mitomycin
Dosage: inj
Indication: Peritoneal Carcinoma Metastatic
Nedaplatin
Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
Indication: Peritoneal Carcinoma Metastatic
Irinotecan HCL
Dosage: on day 1, 15
Indication: Peritoneal Carcinoma Metastatic
Cytarabine
Indication: Peritoneal Carcinoma Metastatic
Doxil
Indication: Peritoneal Carcinoma Metastatic
Epirubicin Hydrochloride
Dosage: day1
Indication: Peritoneal Carcinoma Metastatic
Docetaxel
Indication: Peritoneal Carcinoma Metastatic
Methotrexate
Indication: Peritoneal Carcinoma Metastatic
Prednisolone
Indication: Peritoneal Carcinoma Metastatic
Carboplatin
Dosage: 1df=auc5 also auc4
Indication: Peritoneal Carcinoma Metastatic
Paclitaxel
Indication: Peritoneal Carcinoma Metastatic
Cyclophosphamide
Dosage: cyclophosphamide hydrate day1 also 600mg/m2
Indication: Peritoneal Carcinoma Metastatic
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 59 year old female
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: 59 year old female
Reactions: Drug Interaction, Pancreatitis
Drug(s) suspected as cause:
Doxil
Other drugs received by patient possibly interacting with the suspect drug: Carboplatin
Dosage: used for 1-4 months
Indication: Breast Cancer
Bevacizumab
Dosage: used for 1-6 months
Indication: Breast Cancer
Possible Doxil side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30
Patient: 85 year old male, weighing 82.1 kg (180.6 pounds)
Reactions: Diabetes Mellitus, Oral Candidiasis, Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Blood Creatinine Increased, Blood Urea Increased, Vomiting, Blood Chloride Decreased, Aortic Calcification, Atrial Fibrillation, Pancytopenia, Hyponatraemia, Mitral Valve Calcification, Brain Natriuretic Peptide Increased, Pernicious Anaemia, Dehydration, Mitral Valve Incompetence, Hypothyroidism, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Revlimid
Dosage: 10 mg/daily/po
Administration route: Oral
Indication: Multiple Myeloma
Start date: 2011-01-31
End date: 2011-02-13
Decadron
Dosage: 40 mg/wky/
Indication: Multiple Myeloma
Start date: 2011-01-31
End date: 2011-02-10
Doxil
Dosage: 8 mg
Indication: Multiple Myeloma
Start date: 2011-01-31
End date: 2011-02-10
Velcade
Dosage: 2 mg
Indication: Multiple Myeloma
Start date: 2011-01-31
End date: 2011-02-13
Other drugs received by patient: Procrit; Aspirin; Neurontin; Zometa; Ciprofloxacin; Thioctic Acid; Synthroid; Dflucan; Calcium (Unspecified); Levoxyl; Acyclovir
Possible Doxil side effects in female
Reported by a physician from Japan on 2012-05-30
Patient: female
Reactions: Ovarian Cancer Recurrent, Pneumonia, Aspartate Aminotransferase Increased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Doxil
Dosage: cycle 2
Indication: Ovarian Cancer Recurrent
Start date: 2010-04-28
End date: 2010-04-28
Doxil
Dosage: cycle 1
Start date: 2010-03-31
End date: 2010-03-31
Doxil
Dosage: cycle 3
Start date: 2010-05-26
End date: 2010-05-26
Lipidil
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Doxil
Dosage: cycle 4
Start date: 2010-06-30
End date: 2010-06-30
Doxil
Dosage: cycle 5
Start date: 2010-08-04
End date: 2010-08-04
Other drugs received by patient: Loxoprofen Sodium; Clobetasol Propionate; Pursennid; Azunol; Zofran; Eurax; Mucosta; Loxoprofen Sodium; Cyanocobalamin; Oxatomide; Decadron; White Petrolatum; Hirudoid Cream; Granisetron; Premarin; Atarax; Myser; Lecicarbon; Decadron
Possible Doxil side effects in
Reported by a physician from United States on 2012-05-29
Patient:
Reactions: Anal Abscess
Drug(s) suspected as cause:
Avastin
Indication: Ovarian Cancer
Doxil
Indication: Ovarian Cancer
Possible Doxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23
Patient: male
Reactions: Death, Gastrointestinal Haemorrhage
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Velcade
Dosage: 2.1 mg, unk
Indication: Multiple Myeloma
Start date: 2011-08-04
End date: 2011-10-31
Doxil
Dosage: 30 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2011-08-08
End date: 2011-10-14
Other drugs received by patient: Sorbitol 50pc INJ; Fentanyl-100; Pantoprazole; Epogen; Dexamethasone; Allopurinol; Docusate; Nephro-Vite / 02375601 /; Sevelamer
Possible Doxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female
Reactions: Drug Dose Omission, Cholelithiasis, Death, Vomiting, Ovarian Cancer Recurrent, Nausea
Adverse event resulted in: death
Drug(s) suspected as cause:
Doxil
Indication: Ovarian Cancer
Start date: 2011-01-01
End date: 2011-01-01
Doxil
Start date: 2011-01-01
End date: 2011-01-01
Topotecan
Indication: Ovarian Cancer
Start date: 2011-01-01
Possible Doxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Avastin
Indication: Product Used FOR Unknown Indication
Carboplatin
Indication: Product Used FOR Unknown Indication
Doxil
Indication: Product Used FOR Unknown Indication
Possible Doxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: male, weighing 64.9 kg (142.7 pounds)
Reactions: Hyperproteinaemia, Dysphagia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Bortezomib
Indication: Multiple Myeloma
Start date: 2010-07-01
End date: 2010-08-04
Doxil
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Steroids NOS
Possible Doxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: male, weighing 64.9 kg (142.7 pounds)
Reactions: Hyperproteinaemia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Velcade
Dosage: 1.3 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2010-07-01
End date: 2010-08-04
Doxil
Indication: Multiple Myeloma
Other drugs received by patient: Ambien; Zestril; Prilosec; Flomax; Apresoline; Zestril; Centrum Silver / 01292501 /; Miralax; Lortab; Cortef / 00028601 /; Ativan; Zofran; Norvasc; Flomax; Mucinex; Avodart; MS Contin; Lopurin
Possible Doxil side effects in male
Reported by a individual with unspecified qualification from United States on 2012-05-09
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Small Intestinal Obstruction, Abdominal Abscess, Diffuse Large B-Cell Lymphoma Stage IV, Neoplasm Progression, Febrile Neutropenia, Bacterial Test Positive, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone
Dosage: 500 mg
Cyclophosphamide
Dosage: 1350 mg
Vincristine Sulfate
Dosage: 0 mg
Doxil
Dosage: 72 mg
Rituximab (Moab C2b8 Anti Cd20, Chimeric)
Dosage: 675 mg
Possible Doxil side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-08
Patient: female, weighing 40.5 kg (89.1 pounds)
Reactions: Vomiting, Dyspnoea, Chest Discomfort, Lactobacillus Infection, Nausea, Device Related Infection, Pyrexia, Diarrhoea, Staphylococcal Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 1028 mg
Doxil
Dosage: 55 mg
Vincristine Sulfate
Dosage: 1.9 mg
Prednisone
Dosage: 500 mg
Rituximab (Moab C2b8 Anti Cd20, Chimeric)
Dosage: 514 mg
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 consumer/non-health professional from United States on 2012-04-30
Patient: female
Reactions: Mucosal Inflammation, Periodontal Infection, Multiple Myeloma, Septic Shock, Renal Failure Chronic
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Doxil
Dosage: unk
Indication: Multiple Myeloma
Start date: 2011-04-21
Dexamethasone Sodium Phosphate
Dosage: 20 mg, cyclic
Indication: Multiple Myeloma
Start date: 2011-04-04
End date: 2011-07-13
Velcade
Dosage: 1.6 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2011-04-12
End date: 2011-07-13
Other drugs received by patient: Renalvite; Renvela; Amlodipine; Vancomycin; Triamterene and Hydrochlorothiazid; Lortab; Hydrocodone; Colace; Clindamycin
Possible Doxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27
Patient: male, weighing 64.9 kg (142.7 pounds)
Reactions: Hyperproteinaemia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Velcade
Dosage: 1.3 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2010-07-01
End date: 2010-08-04
Doxil
Indication: Multiple Myeloma
Other drugs received by patient: Mucinex; Miralax; Zofran; Norvasc; Flomax; Zestril; Flomax; Zestril; Ambien; Apresoline; Prilosec; Lortab; Lopurin; Centrum Silver / 01292501 /; Cortef / 00028601 /; Ativan; Avodart; MS Contin
Possible Doxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: female, weighing 56.4 kg (124.1 pounds)
Reactions: Duodenal Ulcer Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Velcade
Dosage: 1.3 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2011-04-15
End date: 2011-05-09
Doxil
Dosage: 30 mg/m2, cyclic
Indication: Multiple Myeloma
Start date: 2011-04-15
Dexamethasone
Dosage: 40 mg, cyclic
Administration route: Oral
Indication: Multiple Myeloma
Start date: 2011-04-15
Other drugs received by patient: Bactrim DS; Acyclovir; Aloxi; Compazine; Fluconazole
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