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Novantrone (Mitoxantrone) - Side Effect Reports to FDA

 
 



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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