Drug information for EFUDEX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CREAM; TOPICAL 5% Prescription AB (Reference Drug) FLUOROURACIL Fluorouracil VALEANT PHARM INTL 16831
2011-06-23 Review
2011-06-23 Review
2011-06-23 Review
2011-06-23 Review
2011-06-23 Review
2011-06-23 Review
2006-05-16 Letter
2005-10-19 Letter
2005-10-19 Label
2004-06-25 Letter
2004-06-25 Label
2004-04-29 Letter
SOLUTION; TOPICAL 2% Prescription AT (Reference Drug) FLUOROURACIL Fluorouracil VALEANT PHARM INTL   "
SOLUTION; TOPICAL 5% Prescription AT (Reference Drug) FLUOROURACIL Fluorouracil VALEANT PHARM INTL   "

Drug Adverse Effects information for EFUDEX

Role code Indications Reaction # Reports
SS ANAEMIA DISSEMINATED INTRAVASCULAR COAGULATION 2
SS ANAEMIA HAEMOGLOBIN DECREASED 2
SS ANAEMIA HYPOTENSION 2
SS ANAEMIA ILEUS PARALYTIC 2
SS ANAEMIA LEUKOPENIA 2
SS ANAEMIA METABOLIC ACIDOSIS 2
SS ANAEMIA NEUTROPENIA 2
SS ANAEMIA PYREXIA 2
SS ANAEMIA RESPIRATORY ALKALOSIS 2
SS ANAEMIA RESPIRATORY FAILURE 2
SS ANAEMIA THROMBOCYTOPENIA 2
SS COLORECTAL CANCER DISSEMINATED INTRAVASCULAR COAGULATION 8
SS COLORECTAL CANCER HAEMOGLOBIN DECREASED 8
SS COLORECTAL CANCER HYPOTENSION 8
SS COLORECTAL CANCER ILEUS PARALYTIC 8
SS COLORECTAL CANCER LEUKOPENIA 8
SS COLORECTAL CANCER METABOLIC ACIDOSIS 8
SS COLORECTAL CANCER NEUTROPENIA 8
SS COLORECTAL CANCER PYREXIA 8
SS COLORECTAL CANCER RESPIRATORY ALKALOSIS 8
SS COLORECTAL CANCER RESPIRATORY FAILURE 8
SS COLORECTAL CANCER THROMBOCYTOPENIA 8
SS HYPOALBUMINAEMIA DISSEMINATED INTRAVASCULAR COAGULATION 2
SS HYPOALBUMINAEMIA HAEMOGLOBIN DECREASED 2
SS HYPOALBUMINAEMIA HYPOTENSION 2
SS HYPOALBUMINAEMIA ILEUS PARALYTIC 2
SS HYPOALBUMINAEMIA LEUKOPENIA 2
SS HYPOALBUMINAEMIA METABOLIC ACIDOSIS 2
SS HYPOALBUMINAEMIA NEUTROPENIA 2
SS HYPOALBUMINAEMIA PYREXIA 2
SS HYPOALBUMINAEMIA RESPIRATORY ALKALOSIS 2
SS HYPOALBUMINAEMIA RESPIRATORY FAILURE 2
SS HYPOALBUMINAEMIA THROMBOCYTOPENIA 2
SS SEDATION DISSEMINATED INTRAVASCULAR COAGULATION 2
SS SEDATION HAEMOGLOBIN DECREASED 2
SS SEDATION HYPOTENSION 2
SS SEDATION ILEUS PARALYTIC 2
SS SEDATION LEUKOPENIA 2
SS SEDATION METABOLIC ACIDOSIS 2
SS SEDATION NEUTROPENIA 2
SS SEDATION PYREXIA 2
SS SEDATION RESPIRATORY ALKALOSIS 2
SS SEDATION RESPIRATORY FAILURE 2
SS SEDATION THROMBOCYTOPENIA 2
C ATRIAL FIBRILLATION INTRA-ABDOMINAL HAEMATOMA 1
C ATRIAL FIBRILLATION RENAL HAEMORRHAGE 1
C COLON CANCER HEPATIC FAILURE 5
C COLON CANCER METASTATIC EPISTAXIS 12
C COLON CANCER METASTATIC GASTROINTESTINAL PERFORATION 12
C COLON CANCER METASTATIC HEPATIC FAILURE 12
C COLON CANCER METASTATIC ILEAL PERFORATION 12
C COLON CANCER METASTATIC ILEAL ULCER 12
C COLON CANCER METASTATIC NEUROPATHY PERIPHERAL 12
C COLON CANCER METASTATIC SEPTIC SHOCK 12
C COLON CANCER METASTATIC SMALL INTESTINE ULCER 12
C MALIGNANT NEOPLASM OF AMPULLA OF VATER ENTEROCUTANEOUS FISTULA 1
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