Drug information for FERAHEME
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SOLUTION; INTRAVENOUS
EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Prescription
(Reference Drug)
FERUMOXYTOL
Ferumoxytol
AMAG PHARMS INC
22180
2011-06-29 Label
2011-06-28 Letter
2010-12-01 Label
2010-12-01 Label
2010-11-30 Letter
2010-11-30 Letter
2009-11-25 Review
2009-11-25 Summary Review
2009-07-07 Letter
2009-07-02 Label
Drug Adverse Effects information for FERAHEME
Role code
Indications
Reaction
# Reports
PS
ANAEMIA
CARDIO-RESPIRATORY ARREST
1
PS
ANAEMIA
CHEST DISCOMFORT
1
PS
ANAEMIA
DYSPNOEA
1
PS
ANAEMIA
HEART RATE INCREASED
1
PS
ANAEMIA
INJECTION SITE DISCOLOURATION
1
PS
ANAEMIA
NAUSEA
1
PS
ANAEMIA
OXYGEN SATURATION DECREASED
1
PS
BLADDER TRANSITIONAL CELL CARCINOMA
CARDIO-RESPIRATORY ARREST
1
PS
CROHN'S DISEASE
BLOOD PRESSURE INCREASED
1
PS
CROHN'S DISEASE
DYSPNOEA
1
PS
CROHN'S DISEASE
FLUSHING
1
PS
CROHN'S DISEASE
PANIC REACTION
1
PS
IRON DEFICIENCY
ATRIAL FIBRILLATION
1
PS
IRON DEFICIENCY
BACK PAIN
1
PS
IRON DEFICIENCY
BLOOD PRESSURE INCREASED
1
PS
IRON DEFICIENCY
CYANOSIS
1
PS
IRON DEFICIENCY
DYSPNOEA
1
PS
IRON DEFICIENCY
EYE MOVEMENT DISORDER
1
PS
IRON DEFICIENCY
HYPERSENSITIVITY
1
PS
IRON DEFICIENCY
HYPOVENTILATION
1
PS
IRON DEFICIENCY
HYPOXIA
1
PS
IRON DEFICIENCY
INFUSION RELATED REACTION
1
PS
IRON DEFICIENCY
MUSCLE CONTRACTIONS INVOLUNTARY
1
PS
IRON DEFICIENCY
MUSCULOSKELETAL DISCOMFORT
1
PS
IRON DEFICIENCY
PULSE ABSENT
1
PS
IRON DEFICIENCY
UNRESPONSIVE TO STIMULI
1
PS
IRON DEFICIENCY
URINARY INCONTINENCE
1
PS
IRON DEFICIENCY ANAEMIA
ABDOMINAL PAIN
2
PS
IRON DEFICIENCY ANAEMIA
ABDOMINAL PAIN UPPER
1
PS
IRON DEFICIENCY ANAEMIA
ANAPHYLACTIC REACTION
3
PS
IRON DEFICIENCY ANAEMIA
ANAPHYLACTOID REACTION
1
PS
IRON DEFICIENCY ANAEMIA
ANXIETY
1
PS
IRON DEFICIENCY ANAEMIA
ASTHENIA
1
PS
IRON DEFICIENCY ANAEMIA
BACK PAIN
7
PS
IRON DEFICIENCY ANAEMIA
BLOOD PRESSURE DECREASED
2
PS
IRON DEFICIENCY ANAEMIA
BLOOD PRESSURE INCREASED
2
PS
IRON DEFICIENCY ANAEMIA
BUNDLE BRANCH BLOCK LEFT
1
PS
IRON DEFICIENCY ANAEMIA
CARDIAC MURMUR
1
PS
IRON DEFICIENCY ANAEMIA
CHEST DISCOMFORT
5
PS
IRON DEFICIENCY ANAEMIA
CHEST PAIN
6
PS
IRON DEFICIENCY ANAEMIA
CHILLS
1
PS
IRON DEFICIENCY ANAEMIA
COLITIS
1
PS
IRON DEFICIENCY ANAEMIA
COUGH
1
PS
IRON DEFICIENCY ANAEMIA
DIARRHOEA
2
PS
IRON DEFICIENCY ANAEMIA
DIARRHOEA HAEMORRHAGIC
1
PS
IRON DEFICIENCY ANAEMIA
DIZZINESS
2
PS
IRON DEFICIENCY ANAEMIA
DRUG HYPERSENSITIVITY
1
PS
IRON DEFICIENCY ANAEMIA
DYSPHAGIA
1
PS
IRON DEFICIENCY ANAEMIA
DYSPNOEA
5
PS
IRON DEFICIENCY ANAEMIA
ERUCTATION
1
PS
IRON DEFICIENCY ANAEMIA
EYE MOVEMENT DISORDER
1
PS
IRON DEFICIENCY ANAEMIA
FEELING ABNORMAL
1
PS
IRON DEFICIENCY ANAEMIA
FLUSHING
5
PS
IRON DEFICIENCY ANAEMIA
HEADACHE
1
PS
IRON DEFICIENCY ANAEMIA
HEART RATE DECREASED
1
PS
IRON DEFICIENCY ANAEMIA
HYPERHIDROSIS
2
PS
IRON DEFICIENCY ANAEMIA
HYPERSENSITIVITY
4
PS
IRON DEFICIENCY ANAEMIA
HYPERTENSION
2
PS
IRON DEFICIENCY ANAEMIA
HYPOTENSION
4
PS
IRON DEFICIENCY ANAEMIA
INFLUENZA
1
PS
IRON DEFICIENCY ANAEMIA
INFUSION RELATED REACTION
1
PS
IRON DEFICIENCY ANAEMIA
LOSS OF CONSCIOUSNESS
1
PS
IRON DEFICIENCY ANAEMIA
MALAISE
4
PS
IRON DEFICIENCY ANAEMIA
MUSCLE SPASMS
1
PS
IRON DEFICIENCY ANAEMIA
NAUSEA
8
PS
IRON DEFICIENCY ANAEMIA
OXYGEN SATURATION DECREASED
2
PS
IRON DEFICIENCY ANAEMIA
PAIN
1
PS
IRON DEFICIENCY ANAEMIA
PRESYNCOPE
1
PS
IRON DEFICIENCY ANAEMIA
PRURITUS
1
PS
IRON DEFICIENCY ANAEMIA
PULSE ABSENT
1
PS
IRON DEFICIENCY ANAEMIA
RASH
3
PS
IRON DEFICIENCY ANAEMIA
RESPIRATORY ARREST
1
PS
IRON DEFICIENCY ANAEMIA
RESTLESSNESS
1
PS
IRON DEFICIENCY ANAEMIA
SINUS CONGESTION
1
PS
IRON DEFICIENCY ANAEMIA
SYNCOPE
2
PS
IRON DEFICIENCY ANAEMIA
TACHYCARDIA
1
PS
IRON DEFICIENCY ANAEMIA
THROAT IRRITATION
1
PS
IRON DEFICIENCY ANAEMIA
THROAT TIGHTNESS
1
PS
IRON DEFICIENCY ANAEMIA
UNRESPONSIVE TO STIMULI
1
PS
IRON DEFICIENCY ANAEMIA
URTICARIA
1
PS
IRON DEFICIENCY ANAEMIA
VOMITING
2
PS
MALABSORPTION
CHEST DISCOMFORT
1
PS
MALABSORPTION
HYPERTENSION
1
PS
MALABSORPTION
NAUSEA
1
PS
MALABSORPTION
PRURITUS
1
PS
MALABSORPTION
RASH
1
PS
MALABSORPTION
SINUS CONGESTION
1
PS
MALABSORPTION
TACHYCARDIA
1
PS
MALABSORPTION
THROAT IRRITATION
1
PS
MENORRHAGIA
CHEST DISCOMFORT
1
PS
MENORRHAGIA
HYPERTENSION
1
PS
MENORRHAGIA
NAUSEA
1
PS
MENORRHAGIA
PRURITUS
1
PS
MENORRHAGIA
RASH
1
PS
MENORRHAGIA
SINUS CONGESTION
1
PS
MENORRHAGIA
TACHYCARDIA
1
PS
MENORRHAGIA
THROAT IRRITATION
1
PS
RENAL FAILURE CHRONIC
ANAPHYLACTIC REACTION
1
PS
RENAL FAILURE CHRONIC
DYSPNOEA
1
PS
RENAL FAILURE CHRONIC
FLUSHING
1
PS
RENAL FAILURE CHRONIC
HYPERHIDROSIS
1
PS
RENAL FAILURE CHRONIC
HYPOTENSION
1
PS
RENAL FAILURE CHRONIC
MALAISE
1
PS
RENAL FAILURE CHRONIC
NAUSEA
1
PS
RENAL FAILURE CHRONIC
PAIN
1
PS
RENAL FAILURE CHRONIC
SYNCOPE
1
PS
SERUM FERRITIN DECREASED
CARDIAC MURMUR
1
PS
SERUM FERRITIN DECREASED
CHEST PAIN
1
C
ANAEMIA
ABDOMINAL DISTENSION
2
C
ANAEMIA
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
2
C
ANAEMIA
APLASIA PURE RED CELL
2
C
ANAEMIA
AURICULAR SWELLING
2
C
ANAEMIA
BLOOD GLUCOSE ABNORMAL
2
C
ANAEMIA
CATHETER PLACEMENT
2
C
ANAEMIA
CATHETER SITE EROSION
2
C
ANAEMIA
CATHETER SITE SWELLING
2
C
ANAEMIA
DRUG ERUPTION
2
C
ANAEMIA
EAR PAIN
2
C
ANAEMIA
FATIGUE
2
C
ANAEMIA
GENERALISED OEDEMA
2
C
ANAEMIA
GYNAECOLOGICAL EXAMINATION ABNORMAL
2
C
ANAEMIA
HERNIA
2
C
ANAEMIA
INCORRECT ROUTE OF DRUG ADMINISTRATION
2
C
ANAEMIA
INFECTION
2
C
ANAEMIA
INFECTIOUS PERITONITIS
2
C
ANAEMIA
IRON DEFICIENCY ANAEMIA
2
C
ANAEMIA
NAUSEA
2
C
ANAEMIA
POST PROCEDURAL HAEMORRHAGE
2
C
ANAEMIA
PYREXIA
2
C
ANAEMIA
THERAPEUTIC RESPONSE DECREASED
4
C
ANAEMIA
TRANSFUSION REACTION
2
C
ANAEMIA
URINE FLOW DECREASED
2
C
ANAEMIA
URINE OUTPUT DECREASED
2
C
ANAEMIA
VOMITING
2
C
ANAEMIA
WEIGHT DECREASED
2
C
ANAEMIA
WEIGHT INCREASED
2
C
CARDIOVASCULAR DISORDER
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
4
C
CARDIOVASCULAR DISORDER
APLASIA PURE RED CELL
4
C
CARDIOVASCULAR DISORDER
AURICULAR SWELLING
4
C
CARDIOVASCULAR DISORDER
DRUG ERUPTION
4
C
CARDIOVASCULAR DISORDER
EAR PAIN
4
C
CARDIOVASCULAR DISORDER
FATIGUE
4
C
CARDIOVASCULAR DISORDER
THERAPEUTIC RESPONSE DECREASED
4
C
CARDIOVASCULAR DISORDER
TRANSFUSION REACTION
4
C
CARDIOVASCULAR DISORDER
WEIGHT DECREASED
4
C
HYPERLIPIDAEMIA
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
2
C
HYPERLIPIDAEMIA
APLASIA PURE RED CELL
2
C
HYPERLIPIDAEMIA
AURICULAR SWELLING
2
C
HYPERLIPIDAEMIA
DRUG ERUPTION
2
C
HYPERLIPIDAEMIA
EAR PAIN
2
C
HYPERLIPIDAEMIA
FATIGUE
2
C
HYPERLIPIDAEMIA
THERAPEUTIC RESPONSE DECREASED
2
C
HYPERLIPIDAEMIA
TRANSFUSION REACTION
2
C
HYPERLIPIDAEMIA
WEIGHT DECREASED
2
C
IRON DEFICIENCY
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
4
C
IRON DEFICIENCY
APLASIA PURE RED CELL
4
C
IRON DEFICIENCY
AURICULAR SWELLING
2
C
IRON DEFICIENCY
DRUG ERUPTION
2
C
IRON DEFICIENCY
EAR PAIN
2
C
IRON DEFICIENCY
FATIGUE
2
C
IRON DEFICIENCY
THERAPEUTIC RESPONSE DECREASED
4
C
IRON DEFICIENCY
TRANSFUSION REACTION
4
C
IRON DEFICIENCY
WEIGHT DECREASED
2
C
MYELODYSPLASTIC SYNDROME
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
2
C
MYELODYSPLASTIC SYNDROME
APLASIA PURE RED CELL
2
C
MYELODYSPLASTIC SYNDROME
AURICULAR SWELLING
2
C
MYELODYSPLASTIC SYNDROME
DRUG ERUPTION
2
C
MYELODYSPLASTIC SYNDROME
EAR PAIN
2
C
MYELODYSPLASTIC SYNDROME
FATIGUE
2
C
MYELODYSPLASTIC SYNDROME
THERAPEUTIC RESPONSE DECREASED
2
C
MYELODYSPLASTIC SYNDROME
TRANSFUSION REACTION
2
C
MYELODYSPLASTIC SYNDROME
WEIGHT DECREASED
2
C
RENAL FAILURE
ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE
6
C
RENAL FAILURE
APLASIA PURE RED CELL
6
C
RENAL FAILURE
AURICULAR SWELLING
2
C
RENAL FAILURE
DRUG ERUPTION
2
C
RENAL FAILURE
EAR PAIN
2
C
RENAL FAILURE
FATIGUE
2
C
RENAL FAILURE
THERAPEUTIC RESPONSE DECREASED
6
C
RENAL FAILURE
TRANSFUSION REACTION
6
C
RENAL FAILURE
WEIGHT DECREASED
2
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