Drug information for FERRLECIT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 62.5MG/5ML Prescription AB (Reference Drug) SODIUM FERRIC GLUCONATE COMPLEX ferric gluconate SANOFI AVENTIS US 20955
2011-08-26 Letter

2011-08-26 Letter

2011-08-26 Label

2011-08-26 Label

2007-04-30 Review

2007-04-30 Review

2006-10-05 Letter

2006-10-05 Label

2004-08-25 Letter

2004-08-25 Label

2003-07-23 Letter

2003-04-25 Label

2002-06-07 Letter

1999-02-18 Letter

1999-02-18 Review

1999-02-18 Label

Drug Adverse Effects information for FERRLECIT

Role code Indications Reaction # Reports
SS DEVICE OCCLUSION CHEST DISCOMFORT 1
SS DEVICE OCCLUSION CYANOSIS 1
SS DEVICE OCCLUSION LIP SWELLING 1
SS DEVICE OCCLUSION LOSS OF CONSCIOUSNESS 1
SS DEVICE OCCLUSION SWOLLEN TONGUE 1
SS IRON DEFICIENCY CHEST DISCOMFORT 1
SS IRON DEFICIENCY CYANOSIS 1
SS IRON DEFICIENCY LIP SWELLING 1
SS IRON DEFICIENCY LOSS OF CONSCIOUSNESS 1
SS IRON DEFICIENCY SWOLLEN TONGUE 1
C ANGIOGRAM AORTIC CALCIFICATION 2
C ANGIOGRAM ARTERIOSCLEROSIS CORONARY ARTERY 2
C ANGIOGRAM ARTHRALGIA 5
C ANGIOGRAM DYSSTASIA 5
C ANGIOGRAM GAIT DISTURBANCE 5
C ANGIOGRAM JOINT CONTRACTURE 7
C ANGIOGRAM JOINT RANGE OF MOTION DECREASED 7
C ANGIOGRAM LICHENIFICATION 5
C ANGIOGRAM MUSCULOSKELETAL STIFFNESS 7
C ANGIOGRAM NEPHROGENIC SYSTEMIC FIBROSIS 12
C ANGIOGRAM OCULAR ICTERUS 5
C ANGIOGRAM OEDEMA PERIPHERAL 5
C ANGIOGRAM PAIN 12
C ANGIOGRAM PAIN IN EXTREMITY 5
C ANGIOGRAM PRURITUS 2
C ANGIOGRAM PULMONARY FIBROSIS 5
C ANGIOGRAM SKIN EXFOLIATION 2
C ANGIOGRAM SKIN FIBROSIS 2
C ANGIOGRAM SKIN HYPERPIGMENTATION 10
C ANGIOGRAM SKIN INDURATION 12
C ANGIOGRAM SKIN LESION 2
C ANGIOGRAM SKIN PLAQUE 2
C ANGIOGRAM SKIN TIGHTNESS 7
C ANTIBIOTIC THERAPY TOOTH DISORDER 1
C ANTIBIOTIC THERAPY TOOTHACHE 1
C GASTRITIS DILATATION ATRIAL 1
C GASTRITIS HYPERTENSIVE CRISIS 1
C GASTRITIS SINUS TACHYCARDIA 1
C HAEMOLYTIC URAEMIC SYNDROME HAEMOGLOBIN DECREASED 1
C HAEMOLYTIC URAEMIC SYNDROME MYOCARDITIS 1
C HYPERPARATHYROIDISM CARDIAC FAILURE 2
C HYPERPARATHYROIDISM COLITIS ISCHAEMIC 1
C HYPERPARATHYROIDISM HYPERPHOSPHATAEMIA 1
C HYPERPARATHYROIDISM KNEE ARTHROPLASTY 2
C HYPERPARATHYROIDISM MYOCARDIAL INFARCTION 2
C HYPERPARATHYROIDISM PNEUMONIA 1
C HYPERPARATHYROIDISM URINARY TRACT INFECTION 2
C HYPERPARATHYROIDISM SECONDARY BACTERIAL INFECTION 1
C HYPERPARATHYROIDISM SECONDARY DILATATION ATRIAL 1
C HYPERPARATHYROIDISM SECONDARY HEADACHE 2
C HYPERPARATHYROIDISM SECONDARY HYPERCALCAEMIA 1
C HYPERPARATHYROIDISM SECONDARY HYPERKALAEMIA 1
C HYPERPARATHYROIDISM SECONDARY HYPERTENSIVE CRISIS 1
C HYPERPARATHYROIDISM SECONDARY INFECTION 1
C HYPERPARATHYROIDISM SECONDARY LEUKOPENIA 1
C HYPERPARATHYROIDISM SECONDARY PERICARDIAL EFFUSION 1
C HYPERPARATHYROIDISM SECONDARY PERICARDITIS 1
C HYPERPARATHYROIDISM SECONDARY PNEUMONIA 2
C HYPERPARATHYROIDISM SECONDARY SINUS TACHYCARDIA 1
C HYPERPARATHYROIDISM SECONDARY TONSILLITIS 1
C HYPERTENSION DILATATION ATRIAL 2
C HYPERTENSION HAEMOGLOBIN DECREASED 2
C HYPERTENSION HYPERTENSIVE CRISIS 2
C HYPERTENSION MYOCARDITIS 2
C HYPERTENSION SINUS TACHYCARDIA 2
C NEPHROGENIC ANAEMIA HAEMOGLOBIN DECREASED 1
C NEPHROGENIC ANAEMIA MYOCARDITIS 1
C NEPHROGENIC ANAEMIA RETROGRADE AMNESIA 1
C NUCLEAR MAGNETIC RESONANCE IMAGING ARTHRALGIA 5
C NUCLEAR MAGNETIC RESONANCE IMAGING DYSSTASIA 5
C NUCLEAR MAGNETIC RESONANCE IMAGING GAIT DISTURBANCE 5
C NUCLEAR MAGNETIC RESONANCE IMAGING JOINT CONTRACTURE 5
C NUCLEAR MAGNETIC RESONANCE IMAGING JOINT RANGE OF MOTION DECREASED 5
C NUCLEAR MAGNETIC RESONANCE IMAGING LICHENIFICATION 5
C NUCLEAR MAGNETIC RESONANCE IMAGING MUSCULOSKELETAL STIFFNESS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING NEPHROGENIC SYSTEMIC FIBROSIS 10
C NUCLEAR MAGNETIC RESONANCE IMAGING OCULAR ICTERUS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING OEDEMA PERIPHERAL 5
C NUCLEAR MAGNETIC RESONANCE IMAGING PAIN 10
C NUCLEAR MAGNETIC RESONANCE IMAGING PAIN IN EXTREMITY 5
C NUCLEAR MAGNETIC RESONANCE IMAGING PULMONARY FIBROSIS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN HYPERPIGMENTATION 10
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN INDURATION 10
C NUCLEAR MAGNETIC RESONANCE IMAGING SKIN TIGHTNESS 5
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ARTHRALGIA 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN DYSSTASIA 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN GAIT DISTURBANCE 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN JOINT CONTRACTURE 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN JOINT RANGE OF MOTION DECREASED 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN LICHENIFICATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN NEPHROGENIC SYSTEMIC FIBROSIS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN OCULAR ICTERUS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN OEDEMA PERIPHERAL 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN PAIN 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN PULMONARY FIBROSIS 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN HYPERPIGMENTATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN INDURATION 1
C NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN SKIN TIGHTNESS 1
C PRODUCT USED FOR UNKNOWN INDICATION BACTERIAL INFECTION 25
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE 42
C PRODUCT USED FOR UNKNOWN INDICATION COLITIS ISCHAEMIC 21
C PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 7
C PRODUCT USED FOR UNKNOWN INDICATION DILATATION ATRIAL 16
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 112
C PRODUCT USED FOR UNKNOWN INDICATION ELECTROCARDIOGRAM QT PROLONGED 7
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 54
C PRODUCT USED FOR UNKNOWN INDICATION HYPERCALCAEMIA 27
C PRODUCT USED FOR UNKNOWN INDICATION HYPERKALAEMIA 27
C PRODUCT USED FOR UNKNOWN INDICATION HYPERPHOSPHATAEMIA 21
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSIVE CRISIS 16
C PRODUCT USED FOR UNKNOWN INDICATION INFECTION 25
C PRODUCT USED FOR UNKNOWN INDICATION KNEE ARTHROPLASTY 42
C PRODUCT USED FOR UNKNOWN INDICATION LEUKOPENIA 25
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 42
C PRODUCT USED FOR UNKNOWN INDICATION PERICARDIAL EFFUSION 25
C PRODUCT USED FOR UNKNOWN INDICATION PERICARDITIS 25
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 75
C PRODUCT USED FOR UNKNOWN INDICATION SINUS TACHYCARDIA 16
C PRODUCT USED FOR UNKNOWN INDICATION TONSILLITIS 25
C PRODUCT USED FOR UNKNOWN INDICATION TOOTH DISORDER 83
C PRODUCT USED FOR UNKNOWN INDICATION TOOTHACHE 29
C PRODUCT USED FOR UNKNOWN INDICATION TRACHEOBRONCHITIS 112
C PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 42
C RENAL FAILURE HAEMOGLOBIN DECREASED 6
C RENAL FAILURE MYOCARDITIS 6
C RENAL FAILURE CHRONIC ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE 6
C RENAL FAILURE CHRONIC DRUG INEFFECTIVE 6
C RENAL FAILURE CHRONIC DYSPNOEA 4
C RENAL FAILURE CHRONIC HAEMOGLOBIN DECREASED 6
C RENAL FAILURE CHRONIC TRACHEOBRONCHITIS 4
C SECONDARY HYPERTHYROIDISM TOOTH DISORDER 3
C SECONDARY HYPERTHYROIDISM TOOTHACHE 1
C STATUS EPILEPTICUS CONDITION AGGRAVATED 2
C STATUS EPILEPTICUS ELECTROCARDIOGRAM QT PROLONGED 2
C TRACHEOBRONCHITIS DYSPNOEA 3
C TRACHEOBRONCHITIS TRACHEOBRONCHITIS 3
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