This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Novantrone (Mitoxantrone) 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 (110)
Death (25)
Life Threatening Events (1)
Reports by Reaction Type
Acute Promyelocytic Leukaemia (21),
Cardiac Failure (12),
Acute Myeloid Leukaemia (10),
Cardiac Failure Congestive (7),
Febrile Neutropenia (6),
Cardiomyopathy (6),
Leukaemia (6),
Bone Pain (5),
Lung Infection (5),
Pneumonia Fungal (5),
Mucosal Inflammation (5),
Syncope (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Novantrone (Mitoxantrone). For a complete list or a specific selection of reports, please use the links above.
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Cardiac Failure, Myocardial Infarction
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient: 52 year old female
Reactions: Neoplasm Malignant, Acute Myeloid Leukaemia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 6 courses at 500 mg/m2 (cumulative dose : 3000 mg/m2)
Indication: Breast Cancer
Start date: 1991-01-01
End date: 1991-01-01
Fluorouracil
Dosage: 6 courses at 500 mg/m2 m2 (cumulative dose : 3000 mg/m2)
Indication: Breast Cancer
Start date: 1991-01-01
End date: 1991-01-01
Novantrone
Dosage: 6 courses
Indication: Breast Cancer
Start date: 1991-01-01
End date: 1991-01-01
Possible Novantrone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female
Reactions: Dyspepsia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-25
Patient: female
Reactions: Oedema Peripheral, Pulse Pressure Decreased, Blood Disorder
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-24
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Menstrual Disorder, Ejection Fraction Decreased
Drug(s) suspected as cause:
Novantrone
Indication: Multiple Sclerosis
Start date: 2001-06-28
End date: 2001-12-27
Novantrone
End date: 2002-05-10
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-24
Patient: female, weighing 51.0 kg (112.2 pounds)
Reactions: Bone Pain, Urinary Tract Infection, Ataxia, Injury, Fall
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-24
Patient: female, weighing 41.0 kg (90.2 pounds)
Reactions: Cardiac Failure
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12
Patient: female
Reactions: Ejection Fraction Abnormal
Drug(s) suspected as cause:
Novantrone
Other drugs received by patient: Rebif
Possible Novantrone side effects in 46 year old female
Reported by a physician from Japan on 2012-07-11
Patient: 46 year old female, weighing 42.0 kg (92.4 pounds)
Reactions: Gastrointestinal Haemorrhage, Neoplasm Malignant, Pseudomembranous Colitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: also received on 27apr09 and 27aug09.900mg 1000mg:18aug10,01dec10, 900mg:14jan11.
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-02
End date: 2011-01-14
Cytarabine
Dosage: form: inj 40mg 5apr2010-11mar2011
Indication: Acute Lymphocytic Leukaemia
Start date: 2010-02-08
End date: 2011-03-11
Doripenem Monohydrate
Start date: 2010-02-22
End date: 2010-02-24
Maxipime
Start date: 2010-02-13
End date: 2010-02-23
Methotrexate
Dosage: form: inj;also on 22apr09 and 20may09. from05apr10-11mar11
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-01
End date: 2011-03-11
Novantrone
Dosage: form:inj; initial 27apr09(9mg)and 27aug09(10mg) 10mg:18aug10,01dec10, 9mg:14jan11
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-02
End date: 2011-01-14
Oncovin
Dosage: form: inj; also received on 27apr09 and 27aug09. 1.5mg:18aug10,01dec10,14jan11.
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-02
End date: 2011-01-14
Prednisolone
Dosage: tab;60mg:27apr9-1may,90mg:27aug09-uk,90mg:18ag-22ag10,1dc-5dc10,14jn-18jn11.inj:15mg:5apr10-11mar11
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-02
End date: 2011-03-11
Prednisolone Sodium
Dosage: form: inj;also on 22apr09,20may09 and 17aug09-18aug09. 20mg:05apr10-11mar11
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-10-01
End date: 2011-03-11
Sprycel
Dosage: 100mg/d:19mar09-21feb10,08mar-21jun10, 70mg/d: 22jun-10aug10, 100mg/d:11aug10-29mar11.
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-03-19
End date: 2011-03-29
Other drugs received by patient: Neutrogin
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-10
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Menstrual Disorder, Ejection Fraction Decreased
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-07-09
Patient: male
Reactions: Cardiac Failure Congestive
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-06
Patient: female
Reactions: Electrocardiogram ST Segment Abnormal, Muscular Weakness
Drug(s) suspected as cause:
Novantrone
Indication: Product Used FOR Unknown Indication
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-27
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-07-03
Patient: male
Reactions: Sepsis, Lung Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytarabine
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
Etoposide
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
MDX-1338 / BMS 936564
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-07
End date: 2011-11-18
Novantrone
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
Other drugs received by patient: Nicotine; Heparin Lock-Flush; Trazodone HCL; Miralax; Pred Forte; Vfend; Prograf; Valtrex; Zofran; Vantin; Magnesium Sulfate; Megace; Remeron; Calcium Carbonate
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-07-03
Patient: female
Reactions: White Blood Cell Count Decreased, Cytomegalovirus Test Positive, Generalised Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novantrone
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-04-05
End date: 2009-04-07
Sprycel
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-04-11
End date: 2009-09-01
Sprycel
Administration route: Oral
Start date: 2009-09-02
Other drugs received by patient: Filgrastim; Rabeprazole Sodium; Dexamethasone Sodium Phosphate Ophthalmic Solution,0.1%; Amlodipine; Entecavir
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-06-29
Patient: male
Reactions: Cardiac Failure
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: White Blood Cell Count Decreased, Haemoglobin Decreased, Neutropenia, Thrombocytopenia
Drug(s) suspected as cause:
Fludarabine Phosphate
Start date: 2008-08-04
Fludarabine Phosphate
Indication: Lymphocytic Lymphoma
Start date: 2008-07-07
End date: 2008-07-10
Fludarabine Phosphate
Indication: Lymphoma
Start date: 2004-05-18
End date: 2004-05-19
Novantrone
Indication: Renal Cancer
Start date: 2008-08-04
Novantrone
Indication: Lymphoma
Start date: 2008-07-07
Other drugs received by patient: Cytoxan; Decadron; Cytoxan; Anzemet; Cytoxan; Vincristine
Possible Novantrone side effects in
Reported by a physician from United States on 2012-06-20
Patient: , weighing 51.0 kg (112.2 pounds)
Reactions: Bone Pain, Urinary Tract Infection, Ataxia, Injury
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in
Reported by a physician from United States on 2012-06-20
Patient:
Reactions: Contusion, Cardiac Failure, Bone Pain, Rash, Pallor, Infection
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in 55 year old female
Reported by a physician from United States on 2012-06-19
Patient: 55 year old female, weighing 41.0 kg (90.2 pounds)
Reactions: Cardiac Failure
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-06-08
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Menstrual Disorder, Ejection Fraction Decreased
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: female
Reactions: Breast Cancer
Drug(s) suspected as cause:
Novantrone
Other drugs received by patient: Prilosec; Cymbalta
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-06-01
Patient: male, weighing 57.0 kg (125.4 pounds)
Reactions: Cardiac Failure, Infection
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-06-01
Patient: male
Reactions: Lung Infection, Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytarabine
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
Etoposide
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
MDX-1338
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-07
End date: 2011-11-14
Novantrone
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
End date: 2011-11-18
Other drugs received by patient: Megace; Valtrex; Heparin Lock-Flush; Trazodone HCL; Vantin; Prograf; Remeron; Calcium Carbonate; Pred Forte; Nicotine; Vfend; Magnesium; Zofran; Miralax
Possible Novantrone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: female
Reactions: Cardiac Failure Congestive
Drug(s) suspected as cause:
Novantrone
Indication: Product Used FOR Unknown Indication
Start date: 2003-01-01
End date: 2005-02-01
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2011-02-04
End date: 2012-03-01
Other drugs received by patient: Cymbalta; Multi-Vitamin; Acthar
Possible Novantrone side effects in male
Reported by a physician from United States on 2012-05-30
Patient: male
Reactions: Sepsis, Lung Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytarabine
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
Etoposide
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
MDX-1338 / BMS 936564
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-07
Novantrone
Indication: Acute Myeloid Leukaemia
Start date: 2011-11-14
Other drugs received by patient: Nicotine; Miralax; Pred Forte; Trazodone HCL; Prograf; Remeron; Vantin; Zofran; Magnesium; Megace; Vfend; Calcium Carbonate; Heparin; Valtrex
Possible Novantrone side effects in 51 year old male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: 51 year old male, weighing 120.2 kg (264.4 pounds)
Reactions: Electroencephalogram Abnormal, Syncope, Head Injury, Gastrointestinal Disorder, Cerebral Haemangioma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novantrone
Dosage: iv 90 days intra-arterial
Indication: Multiple Sclerosis
Start date: 2009-04-24
End date: 2011-12-12
Novantrone
Dosage: iv 90 days intra-arterial
Indication: Adjuvant Therapy
Start date: 2009-04-24
End date: 2011-12-12
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-05-29
Patient: female
Reactions: Leukaemia
Drug(s) suspected as cause:
Novantrone
Possible Novantrone side effects in 52 year old female
Reported by a physician from United States on 2012-05-29
Patient: 52 year old female
Reactions: Oesophageal Mass, Multi-Organ Failure, Gene Mutation, Acute Myeloid Leukaemia, Refractory Cytopenia With Multilineage Dysplasia, Chloroma
Drug(s) suspected as cause:
Cytarabine
Indication: Refractory Cytopenia With Multilineage Dysplasia
Idarubicin HCL
Indication: Acute Promyelocytic Leukaemia
Mercaptopurine
Dosage: 50 mg/m 2 milligram(s)/sq. meter
Indication: Acute Promyelocytic Leukaemia
Methotrexate
Dosage: 15 mg/m^2 per week
Indication: Acute Promyelocytic Leukaemia
Novantrone
Dosage: 10 mg/m 2 milligram(s)/sq. metere
Indication: Acute Promyelocytic Leukaemia
Tretinoin
Dosage: 45 mg/m 2 milligram(s)/sq. meter
Indication: Acute Promyelocytic Leukaemia
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-05-25
Patient: female, weighing 63.0 kg (138.6 pounds)
Reactions: Acute Promyelocytic Leukaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novantrone
Start date: 2003-10-03
End date: 2003-10-03
Novantrone
Start date: 2003-05-01
End date: 2003-05-01
Novantrone
Indication: Multiple Sclerosis
Start date: 2001-04-12
End date: 2001-04-12
Novantrone
Start date: 2002-06-13
End date: 2002-06-13
Novantrone
Start date: 2003-01-17
End date: 2003-01-17
Novantrone
Start date: 2002-09-12
End date: 2002-09-12
Novantrone
Start date: 2001-08-02
End date: 2001-08-02
Other drugs received by patient: Ditropan XL; Baclofen; Lipitor; Vitamin TAB; Tegretol; Cranberry; Probiotic; Neurontin; Glucosamine
Possible Novantrone side effects in female
Reported by a physician from United States on 2012-05-23
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Fatigue, Nausea, Alopecia, Ejection Fraction Decreased, Decreased Appetite
Drug(s) suspected as cause:
Novantrone
Other drugs received by patient: Solu-Medrol; Lipitor
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