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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