Drug information for ELOXATIN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; IV (INFUSION)
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Discontinued
OXALIPLATIN
oxaliplatin
SANOFI AVENTIS US
21492
2012-01-03 Letter
2011-12-28 Label
2009-03-26 Label
2009-03-17 Letter
2008-05-28 Letter
2007-01-16 Label
2007-01-16 Letter
2006-03-24 Review
2006-03-14 Label
2006-03-14 Letter
2004-11-08 Letter
2004-11-08 Letter
2004-11-05 Label
2004-11-05 Label
2004-06-03 Letter
2004-01-15 Label
2004-01-12 Letter
2003-04-22 Other Important Information from FDA
2002-08-09 Letter
2002-08-09 Label
2002-08-09 Review
INJECTABLE; IV (INFUSION)
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Discontinued
OXALIPLATIN
oxaliplatin
SANOFI AVENTIS US
"
INJECTABLE; IV (INFUSION)
100MG/20ML (5MG/ML)
Prescription
AP (Reference Drug)
OXALIPLATIN
oxaliplatin
SANOFI AVENTIS US
21759
2012-01-03 Letter
2011-12-28 Label
2009-03-26 Label
2009-03-17 Letter
2008-05-28 Letter
2007-07-02 Review
2006-03-14 Label
2006-03-14 Letter
2005-02-03 Letter
2005-02-03 Label
INJECTABLE; IV (INFUSION)
200MG/40ML (5MG/ML)
Prescription
(Reference Drug)
OXALIPLATIN
oxaliplatin
SANOFI AVENTIS US
"
INJECTABLE; IV (INFUSION)
50MG/10ML (5MG/ML)
Prescription
AP (Reference Drug)
OXALIPLATIN
oxaliplatin
SANOFI AVENTIS US
"
Drug Adverse Effects information for ELOXATIN
Role code
Indications
Reaction
# Reports
PS
BILE DUCT CANCER
DRUG INEFFECTIVE
1
PS
BILE DUCT CANCER
HICCUPS
1
PS
BILE DUCT CANCER
HYPERSENSITIVITY
1
PS
BILE DUCT CANCER
NEUROPATHY PERIPHERAL
1
PS
BILE DUCT CANCER
TRISMUS
1
PS
COLON CANCER
ABDOMINAL PAIN
1
PS
COLON CANCER
ALTERED STATE OF CONSCIOUSNESS
2
PS
COLON CANCER
CARDIAC FAILURE
2
PS
COLON CANCER
CHEST PAIN
2
PS
COLON CANCER
DISEASE PROGRESSION
1
PS
COLON CANCER
DYSPNOEA
2
PS
COLON CANCER
HYPERHIDROSIS
2
PS
COLON CANCER
MULTIFOCAL MOTOR NEUROPATHY
3
PS
COLON CANCER
RENAL FAILURE ACUTE
2
PS
COLON CANCER
VITAL FUNCTIONS ABNORMAL
2
PS
COLORECTAL CANCER
ABDOMINAL PAIN
1
PS
COLORECTAL CANCER
CARDIOGENIC SHOCK
2
PS
COLORECTAL CANCER
CHEST PAIN
2
PS
COLORECTAL CANCER
CYANOSIS
1
PS
COLORECTAL CANCER
EXTRAVASATION
2
PS
COLORECTAL CANCER
GUILLAIN-BARRE SYNDROME
1
PS
COLORECTAL CANCER
HYPOTENSION
2
PS
COLORECTAL CANCER
SKIN INDURATION
2
PS
ENTERITIS
DECREASED APPETITE
1
PS
ENTERITIS
DEHYDRATION
1
PS
ENTERITIS
DEVICE RELATED INFECTION
1
PS
ENTERITIS
DIARRHOEA
1
PS
ENTERITIS
GASTRITIS EROSIVE
1
PS
ENTERITIS
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
ENTERITIS
LOWER GASTROINTESTINAL HAEMORRHAGE
1
PS
ENTERITIS
VOMITING
1
PS
GASTRIC CANCER
PAIN
3
PS
GASTRIC CANCER
RESPIRATORY DISTRESS
3
PS
GASTROINTESTINAL INFLAMMATION
DECREASED APPETITE
1
PS
GASTROINTESTINAL INFLAMMATION
DEHYDRATION
1
PS
GASTROINTESTINAL INFLAMMATION
DEVICE RELATED INFECTION
1
PS
GASTROINTESTINAL INFLAMMATION
DIARRHOEA
1
PS
GASTROINTESTINAL INFLAMMATION
GASTRITIS EROSIVE
1
PS
GASTROINTESTINAL INFLAMMATION
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
GASTROINTESTINAL INFLAMMATION
LOWER GASTROINTESTINAL HAEMORRHAGE
1
PS
GASTROINTESTINAL INFLAMMATION
VOMITING
1
PS
INSOMNIA
CONSTIPATION
1
PS
INSOMNIA
DYSGRAPHIA
1
PS
INSOMNIA
DYSPNOEA
1
PS
INSOMNIA
FEELING COLD
1
PS
INSOMNIA
GAIT DISTURBANCE
1
PS
INSOMNIA
HEPATIC NEOPLASM MALIGNANT RESECTABLE
1
PS
INSOMNIA
HYPOAESTHESIA
1
PS
INSOMNIA
NEUROPATHY PERIPHERAL
1
PS
INSOMNIA
PARAESTHESIA
1
PS
MALNUTRITION
DECREASED APPETITE
3
PS
MALNUTRITION
DEHYDRATION
3
PS
MALNUTRITION
DEVICE RELATED INFECTION
3
PS
MALNUTRITION
DIARRHOEA
3
PS
MALNUTRITION
GASTRITIS EROSIVE
3
PS
MALNUTRITION
GASTROOESOPHAGEAL REFLUX DISEASE
3
PS
MALNUTRITION
LOWER GASTROINTESTINAL HAEMORRHAGE
3
PS
MALNUTRITION
VOMITING
3
PS
NAUSEA
DECREASED APPETITE
1
PS
NAUSEA
DEHYDRATION
1
PS
NAUSEA
DEVICE RELATED INFECTION
1
PS
NAUSEA
DIARRHOEA
1
PS
NAUSEA
GASTRITIS EROSIVE
1
PS
NAUSEA
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
NAUSEA
LOWER GASTROINTESTINAL HAEMORRHAGE
1
PS
NAUSEA
VOMITING
1
PS
NON-SMALL CELL LUNG CANCER
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS
3
PS
NON-SMALL CELL LUNG CANCER
MIXED LIVER INJURY
3
PS
OCCUPATIONAL EXPOSURE TO DRUG
ACCIDENTAL EXPOSURE
1
PS
OCCUPATIONAL EXPOSURE TO DRUG
APPLICATION SITE VESICLES
1
PS
OCCUPATIONAL EXPOSURE TO DRUG
THERMAL BURN
1
PS
RECTAL CANCER
DEATH
1
PS
RECTAL CANCER
DECREASED APPETITE
3
PS
RECTAL CANCER
DEHYDRATION
3
PS
RECTAL CANCER
DEVICE RELATED INFECTION
3
PS
RECTAL CANCER
DIARRHOEA
3
PS
RECTAL CANCER
GASTRITIS EROSIVE
3
PS
RECTAL CANCER
GASTROOESOPHAGEAL REFLUX DISEASE
3
PS
RECTAL CANCER
LOWER GASTROINTESTINAL HAEMORRHAGE
3
PS
RECTAL CANCER
VOMITING
3
PS
RECTAL CANCER STAGE III
BLOOD MAGNESIUM DECREASED
1
PS
RECTAL CANCER STAGE III
DEATH
1
PS
RECTAL CANCER STAGE III
DEHYDRATION
1
PS
RECTAL CANCER STAGE III
DIARRHOEA
1
SS
ADENOCARCINOMA
ANAEMIA
2
SS
ADENOCARCINOMA
GASTROINTESTINAL HAEMORRHAGE
2
SS
ADENOCARCINOMA
THROMBOPHLEBITIS SUPERFICIAL
2
SS
COLON CANCER
ABDOMINAL PAIN
2
SS
COLON CANCER
BLINDNESS
8
SS
COLON CANCER
BLINDNESS TRANSIENT
3
SS
COLON CANCER
CHEST PAIN
9
SS
COLON CANCER
DISEASE PROGRESSION
1
SS
COLON CANCER
DYSPNOEA
9
SS
COLON CANCER
HYPERHIDROSIS
9
SS
COLON CANCER
MULTIFOCAL MOTOR NEUROPATHY
3
SS
COLON CANCER
VITAL FUNCTIONS ABNORMAL
9
SS
COLON CANCER METASTATIC
RENAL FAILURE
4
SS
COLON CANCER METASTATIC
RENAL TUBULAR NECROSIS
4
SS
COLORECTAL CANCER
EXTRAVASATION
2
SS
COLORECTAL CANCER
SKIN INDURATION
2
SS
COLORECTAL CANCER METASTATIC
PARAESTHESIA
5
SS
ENTERITIS
DECREASED APPETITE
1
SS
ENTERITIS
DEHYDRATION
1
SS
ENTERITIS
DEVICE RELATED INFECTION
1
SS
ENTERITIS
DIARRHOEA
1
SS
ENTERITIS
GASTRITIS EROSIVE
1
SS
ENTERITIS
GASTROOESOPHAGEAL REFLUX DISEASE
1
SS
ENTERITIS
LOWER GASTROINTESTINAL HAEMORRHAGE
1
SS
ENTERITIS
VOMITING
1
SS
GASTROINTESTINAL INFLAMMATION
DECREASED APPETITE
1
SS
GASTROINTESTINAL INFLAMMATION
DEHYDRATION
1
SS
GASTROINTESTINAL INFLAMMATION
DEVICE RELATED INFECTION
1
SS
GASTROINTESTINAL INFLAMMATION
DIARRHOEA
1
SS
GASTROINTESTINAL INFLAMMATION
GASTRITIS EROSIVE
1
SS
GASTROINTESTINAL INFLAMMATION
GASTROOESOPHAGEAL REFLUX DISEASE
1
SS
GASTROINTESTINAL INFLAMMATION
LOWER GASTROINTESTINAL HAEMORRHAGE
1
SS
GASTROINTESTINAL INFLAMMATION
VOMITING
1
SS
MALNUTRITION
DECREASED APPETITE
3
SS
MALNUTRITION
DEHYDRATION
3
SS
MALNUTRITION
DEVICE RELATED INFECTION
3
SS
MALNUTRITION
DIARRHOEA
3
SS
MALNUTRITION
GASTRITIS EROSIVE
3
SS
MALNUTRITION
GASTROOESOPHAGEAL REFLUX DISEASE
3
SS
MALNUTRITION
LOWER GASTROINTESTINAL HAEMORRHAGE
3
SS
MALNUTRITION
VOMITING
3
SS
METASTASES TO LIVER
ABDOMINAL PAIN
8
SS
METASTASES TO LIVER
DECREASED APPETITE
8
SS
METASTASES TO LIVER
FEBRILE NEUTROPENIA
8
SS
METASTASES TO LIVER
PYELONEPHRITIS
8
SS
NAUSEA
DECREASED APPETITE
1
SS
NAUSEA
DEHYDRATION
1
SS
NAUSEA
DEVICE RELATED INFECTION
1
SS
NAUSEA
DIARRHOEA
1
SS
NAUSEA
GASTRITIS EROSIVE
1
SS
NAUSEA
GASTROOESOPHAGEAL REFLUX DISEASE
1
SS
NAUSEA
LOWER GASTROINTESTINAL HAEMORRHAGE
1
SS
NAUSEA
VOMITING
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL TUBULAR NECROSIS
4
SS
RECTAL CANCER
DECREASED APPETITE
3
SS
RECTAL CANCER
DEHYDRATION
3
SS
RECTAL CANCER
DEVICE RELATED INFECTION
3
SS
RECTAL CANCER
DIARRHOEA
3
SS
RECTAL CANCER
GASTRITIS EROSIVE
3
SS
RECTAL CANCER
GASTROOESOPHAGEAL REFLUX DISEASE
3
SS
RECTAL CANCER
LOWER GASTROINTESTINAL HAEMORRHAGE
3
SS
RECTAL CANCER
VOMITING
3
SS
THROMBOPHLEBITIS SUPERFICIAL
ANAEMIA
2
SS
THROMBOPHLEBITIS SUPERFICIAL
GASTROINTESTINAL HAEMORRHAGE
2
SS
THROMBOPHLEBITIS SUPERFICIAL
THROMBOPHLEBITIS SUPERFICIAL
2
SS
THROMBOSIS PROPHYLAXIS
RENAL FAILURE
1
SS
THROMBOSIS PROPHYLAXIS
RENAL TUBULAR NECROSIS
1
C
COLON CANCER
ABDOMINAL PAIN
1
C
COLON CANCER
ABDOMINAL RIGIDITY
1
C
COLON CANCER
CARDIOGENIC SHOCK
3
C
COLON CANCER
PULMONARY EMBOLISM
3
C
LEUKOPENIA
WHITE BLOOD CELL COUNT DECREASED
2
C
NON-SMALL CELL LUNG CANCER
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS
1
C
NON-SMALL CELL LUNG CANCER
HEPATOCELLULAR INJURY
1
C
NON-SMALL CELL LUNG CANCER
PANCYTOPENIA
1
Ads by Google