Drug information for DAUNORUBICIN HYDROCHLORIDE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
EQ 5MG BASE/ML
Prescription
AP (Reference Drug)
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
BEDFORD
50731
1998-01-30 Review
INJECTABLE; INJECTION
EQ 20MG BASE/VIAL
Discontinued
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
TEVA PARENTERAL
64212
1998-06-23 Letter
INJECTABLE; INJECTION
EQ 50MG BASE/VIAL
Discontinued
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
TEVA PARENTERAL
"
INJECTABLE; INJECTION
EQ 20MG BASE/VIAL
Prescription
AP
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
APP PHARMS
65000
1999-05-25 Letter
INJECTABLE; INJECTION
EQ 5MG BASE/VIAL
Prescription
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
APP PHARMS
65034
2001-11-20 Letter
INJECTABLE; INJECTION
EQ 5MG BASE/ML
Prescription
AP
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin
TEVA PARENTERAL
65035
2000-01-24 Letter
Drug Adverse Effects information for DAUNORUBICIN HYDROCHLORIDE
Role code
Indications
Reaction
# Reports
SS
ACUTE LEUKAEMIA
CYTOLYTIC HEPATITIS
2
SS
ACUTE MYELOID LEUKAEMIA
AGITATION
12
SS
ACUTE MYELOID LEUKAEMIA
BRAIN OEDEMA
12
SS
ACUTE MYELOID LEUKAEMIA
CAECITIS
8
SS
ACUTE MYELOID LEUKAEMIA
CONVULSION
12
SS
ACUTE MYELOID LEUKAEMIA
DEPRESSED LEVEL OF CONSCIOUSNESS
12
SS
ACUTE MYELOID LEUKAEMIA
DIZZINESS
12
SS
ACUTE MYELOID LEUKAEMIA
DYSAESTHESIA
12
SS
ACUTE MYELOID LEUKAEMIA
ENCEPHALOPATHY
12
SS
ACUTE MYELOID LEUKAEMIA
HEADACHE
12
SS
ACUTE MYELOID LEUKAEMIA
HYPERSOMNIA
12
SS
ACUTE MYELOID LEUKAEMIA
HYPERTENSION
8
SS
ACUTE MYELOID LEUKAEMIA
HYPONATRAEMIA
12
SS
ACUTE MYELOID LEUKAEMIA
HYPOTENSION
5
SS
ACUTE MYELOID LEUKAEMIA
NEURALGIA
12
SS
ACUTE MYELOID LEUKAEMIA
NEUTROPENIC SEPSIS
20
SS
ACUTE MYELOID LEUKAEMIA
PARAESTHESIA
12
SS
ACUTE MYELOID LEUKAEMIA
PERIPHERAL SENSORY NEUROPATHY
12
SS
ACUTE MYELOID LEUKAEMIA
SOMNOLENCE
12
SS
ACUTE PROMYELOCYTIC LEUKAEMIA
FEBRILE NEUTROPENIA
3
SS
ACUTE PROMYELOCYTIC LEUKAEMIA
RETINOIC ACID SYNDROME
3
SS
CHEMOTHERAPY
SHOCK HAEMORRHAGIC
2
SS
CLOSTRIDIUM DIFFICILE COLITIS
ENTEROCOLITIS INFECTIOUS
1
SS
CLOSTRIDIUM DIFFICILE COLITIS
FLUID RETENTION
1
SS
CLOSTRIDIUM DIFFICILE COLITIS
HEADACHE
1
SS
CLOSTRIDIUM DIFFICILE COLITIS
HYPERTENSION
1
SS
CLOSTRIDIUM DIFFICILE COLITIS
NEUTROPHIL COUNT DECREASED
1
SS
CLOSTRIDIUM DIFFICILE COLITIS
WHITE BLOOD CELL COUNT DECREASED
1
SS
CROHN'S DISEASE
SHOCK HAEMORRHAGIC
10
SS
LEUKAEMIA
CYTOLYTIC HEPATITIS
1
SS
LEUKAEMIA
SHOCK HAEMORRHAGIC
2
SS
LYMPHOCYTIC LEUKAEMIA
ENTEROCOLITIS INFECTIOUS
29
SS
LYMPHOCYTIC LEUKAEMIA
FLUID RETENTION
29
SS
LYMPHOCYTIC LEUKAEMIA
HEADACHE
29
SS
LYMPHOCYTIC LEUKAEMIA
HYPERTENSION
29
SS
LYMPHOCYTIC LEUKAEMIA
NEUTROPHIL COUNT DECREASED
29
SS
LYMPHOCYTIC LEUKAEMIA
WHITE BLOOD CELL COUNT DECREASED
29
SS
MELAENA
SHOCK HAEMORRHAGIC
2
SS
MUCOUS MEMBRANE DISORDER
SHOCK HAEMORRHAGIC
2
SS
MYELODYSPLASTIC SYNDROME
NEUTROPENIC SEPSIS
20
SS
PRODUCT USED FOR UNKNOWN INDICATION
SHOCK HAEMORRHAGIC
6
C
ACUTE MYELOID LEUKAEMIA
ACUTE GRAFT VERSUS HOST DISEASE
7
C
ACUTE MYELOID LEUKAEMIA
DIALYSIS
7
C
ACUTE MYELOID LEUKAEMIA
THROMBOTIC MICROANGIOPATHY
7
C
BONE MARROW CONDITIONING REGIMEN
ACUTE GRAFT VERSUS HOST DISEASE
1
C
BONE MARROW CONDITIONING REGIMEN
DIALYSIS
1
C
BONE MARROW CONDITIONING REGIMEN
THROMBOTIC MICROANGIOPATHY
1
C
INFECTION PROPHYLAXIS
ACUTE GRAFT VERSUS HOST DISEASE
3
C
INFECTION PROPHYLAXIS
DIALYSIS
3
C
INFECTION PROPHYLAXIS
THROMBOTIC MICROANGIOPATHY
3
C
PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE
ACUTE GRAFT VERSUS HOST DISEASE
2
C
PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE
DIALYSIS
2
C
PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE
THROMBOTIC MICROANGIOPATHY
2
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