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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