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Aranesp (Erythropoiesis Stimulating Protein) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aranesp (Erythropoiesis Stimulating Protein) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (697)
Death (96)
Life Threatening Events (10)
Disability (1)

Reports by Reaction Type

Aplasia Pure RED Cell (97)Haemoglobin Decreased (88)Anaemia (82)Drug Ineffective (81)Therapeutic Response Decreased (67)Death (60)Fatigue (36)Dyspnoea (31)Asthenia (28)Hospitalisation (20)Thrombocytopenia (20)Nausea (20)

Below are a few examples of reports where side effects / adverse reactions may be related to Aranesp (Erythropoiesis Stimulating Protein). For a complete list or a specific selection of reports, please use the links above.

Possible Aranesp side effects in 69 year old male

Reported by a physician from United States on 2012-08-27

Patient: 69 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Therapeutic Response Decreased, Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: 150 mg, q3wk
    Indication: Renal Failure
    Start date: 2012-01-12
    End date: 2012-04-05

Epogen
    Dosage: 16000 iu, unk
    Start date: 2012-06-04
    End date: 2012-06-11

Epogen
    Dosage: 11000 iu, unk
    Start date: 2012-05-14
    End date: 2012-05-21

Epogen
    Dosage: 26000 iu, unk
    Start date: 2012-07-11
    End date: 2012-07-16

Epogen

Epogen
    Dosage: unk
    Indication: Renal Failure
    Start date: 2012-04-20
    End date: 2012-07-16

Epogen
    Dosage: 10000 iu, unk
    Start date: 2012-04-20
    End date: 2012-05-03

Epogen
    Dosage: 21000 iu, unk
    Start date: 2012-06-15
    End date: 2012-07-10

Other drugs received by patient: Allopurinol; Leflunomide



Possible Aranesp side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-27

Patient: 62 year old male

Reactions: Gastric Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 43 year old female

Reported by a physician from Canada on 2012-08-27

Patient: 43 year old female

Reactions: Aplasia Pure RED Cell

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp

Aranesp
    Dosage: 150 mug, qwk
    Indication: Renal Failure Chronic
    Start date: 2012-06-27
    End date: 2012-07-14

Other drugs received by patient: Plaquenil; Azathioprine Sodium; Furosemide; Prednisone TAB; Labetalol HCL; Irbesartan



Possible Aranesp side effects in 47 year old male

Reported by a physician from Australia on 2012-08-22

Patient: 47 year old male, weighing 60.2 kg (132.4 pounds)

Reactions: Aplasia Pure RED Cell

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-22

Patient: 82 year old female

Reactions: Drug Ineffective, Aplasia Pure RED Cell

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in

Reported by a pharmacist from United States on 2012-08-22

Patient:

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 69 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Therapeutic Response Decreased, Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: 151 mg, unk
    Start date: 2012-02-01

Aranesp
    Dosage: 153 mg, unk
    Start date: 2012-03-13

Aranesp
    Dosage: 152 mg, unk
    Start date: 2012-02-22

Aranesp
    Dosage: 154 mg, unk
    Start date: 2012-04-05

Aranesp
    Dosage: 150 mg, q3wk
    Indication: Renal Failure
    Start date: 2012-01-12
    End date: 2012-04-05

Aranesp
    Dosage: 200 mg, unk
    Start date: 2012-07-23

Epogen
    Dosage: 21000 iu, unk
    Start date: 2012-06-15
    End date: 2012-07-10

Epogen
    Dosage: unk
    Indication: Renal Failure
    Start date: 2012-04-20
    End date: 2012-07-16

Epogen
    Dosage: 16000 iu, unk
    Start date: 2012-06-04
    End date: 2012-06-11

Epogen
    Dosage: 26000 iu, unk
    Start date: 2012-07-11
    End date: 2012-07-16

Epogen
    Dosage: 10000 iu, unk
    Start date: 2012-04-20
    End date: 2012-05-03

Epogen
    Dosage: 11000 iu, unk
    Start date: 2012-05-14
    End date: 2012-05-21

Other drugs received by patient: Leflunomide; Allopurinol



Possible Aranesp side effects in 82 year old male

Reported by a physician from United States on 2012-08-21

Patient: 82 year old male

Reactions: Haemoglobin Decreased, Angina Pectoris

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp

Other drugs received by patient: Aspirin; Toprol-XL; Cardura; Prilosec; Mevacor; Neurontin; Multi-Vitamins; Hydrochlorothiazide; Plavix; Avapro



Possible Aranesp side effects in 89 year old male

Reported by a pharmacist from Canada on 2012-08-21

Patient: 89 year old male

Reactions: Drug Ineffective, Fracture, Anaemia, Multiple Myeloma, Aplasia Pure RED Cell

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 57 year old male

Reported by a physician from France on 2012-08-21

Patient: 57 year old male

Reactions: Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp

Other drugs received by patient: Preterax / 01421201 /; Aspirin; Levothyroxine Sodium; Mircera; Flecainide Acetate



Possible Aranesp side effects in 69 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 69 year old

Reactions: Therapeutic Response Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: 152 mg, unk
    Start date: 2012-02-22

Aranesp
    Dosage: 200 mg, unk
    Indication: Renal Failure
    Start date: 2012-07-23

Aranesp
    Dosage: 150 mg, unk
    Start date: 2012-01-12

Aranesp
    Dosage: 151 mg, unk
    Start date: 2012-02-01

Aranesp
    Dosage: 153 mg, unk
    Start date: 2012-03-13

Aranesp
    Dosage: 154 mg, unk
    Start date: 2012-04-05

Epogen
    Dosage: 11000 iu, unk
    Start date: 2012-05-14
    End date: 2012-05-21

Epogen
    Dosage: 26000 iu, unk
    Indication: Neoplasm Malignant
    Start date: 2012-07-11
    End date: 2012-07-16

Epogen
    Dosage: 21000 iu, unk
    Start date: 2012-06-15
    End date: 2012-07-10

Epogen
    Dosage: 16000 iu, unk
    Start date: 2012-06-04
    End date: 2012-06-11

Epogen
    Dosage: 10000 iu, unk
    Start date: 2012-04-20
    End date: 2012-05-03

Other drugs received by patient: Leflunomide; Allopurinol



Possible Aranesp side effects in 76 year old male

Reported by a physician from United Kingdom on 2012-08-20

Patient: 76 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Aranesp
    Dosage: 150 mug, qwk
    Indication: Nephrogenic Anaemia

Binocrit
    Dosage: 1000 iu, qwk
    Start date: 2012-02-19
    End date: 2012-04-10

Binocrit
    Dosage: unk
    Indication: Anaemia
    End date: 2012-04-10



Possible Aranesp side effects in 60 year old female

Reported by a physician from Japan on 2012-08-20

Patient: 60 year old female

Reactions: Hepatic Function Abnormal

Drug(s) suspected as cause:
Aranesp

Other drugs received by patient: Lasix; Crestor; Calcium Carbonate; Alfarol



Possible Aranesp side effects in 49 year old male

Reported by a physician from United States on 2012-08-16

Patient: 49 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Burning Sensation, Nausea, Arthralgia, Oedema Peripheral

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Indication: Anaemia of Malignant Disease
    Start date: 2011-08-13

Neulasta
    Dosage: 6 mg, unk
    Indication: Chemotherapy
    Start date: 2011-08-13

Neupogen
    Dosage: unk
    Indication: Chemotherapy
    Start date: 2011-08-15

Nplate
    Dosage: 500 mug, prn
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-08-15

Other drugs received by patient: Gemzar; Oxycodone; Bactroban; Ondansetron; Oxaliplatin; Nystatin; Remeron; Melatonin; Restoril; Aldactone



Possible Aranesp side effects in 47 year old male

Reported by a physician from Australia on 2012-08-16

Patient: 47 year old male, weighing 60.2 kg (132.4 pounds)

Reactions: Aplasia Pure RED Cell

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 78 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 78 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Eosinophil Count Increased

Drug(s) suspected as cause:
Aranesp
    Dosage: 200 mg, q2wk
    Indication: Anaemia

Neupogen
    Dosage: 480 mug, unk
    Indication: Neutropenia
    Start date: 2012-07-18

Other drugs received by patient: Vancomycin; Triamterene; Synthroid; Vancomycin; Norco; Cefepime; Questran; Florinef



Possible Aranesp side effects in 75 year old male

Reported by a physician from United States on 2012-08-16

Patient: 75 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Medication Error

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Indication: Myelodysplastic Syndrome
    Start date: 2010-07-13

Neupogen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-04

Nplate
    Dosage: 73 mug, one time dose
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-18
    End date: 2011-07-18

Other drugs received by patient: Dacogen



Possible Aranesp side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 68 year old male

Reactions: Nausea, Drug Ineffective, Diarrhoea, Epigastric Discomfort, Dizziness

Drug(s) suspected as cause:
Aranesp
    Dosage: 300 mug, unk
    Indication: Anaemia
    Start date: 2011-07-01

Neupogen
    Indication: Myelodysplastic Syndrome
    Start date: 2011-07-01

Other drugs received by patient: Paxil; Enalapril Maleate; Glimepiride; Lantus; Metoprolol Tartrate; Halcion



Possible Aranesp side effects in 64 year old female

Reported by a physician from United States on 2012-08-14

Patient: 64 year old female

Reactions: Metastatic Neoplasm

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Start date: 2011-12-07

Aranesp

Aranesp
    Dosage: unk
    Indication: Anaemia
    Start date: 2009-01-01

Sensipar
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05

Other drugs received by patient: Claritin / 00413701 /; Zocor; Fluticasone Propionate; Lasix; Miralax / 00754501 /; Synthroid; Ambien; Allopurinol; Nephrocaps / 01801401 /; Wellbutrin; Tylenol (Caplet); Atacand; Nexium; Singulair; Xopenex; Coreg



Possible Aranesp side effects in 45 year old female

Reported by a pharmacist from France on 2012-08-13

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Lung Neoplasm Malignant, Injection Site Pain

Adverse event resulted in: death

Drug(s) suspected as cause:
Aranesp

Other drugs received by patient: Chemotherapeutics



Possible Aranesp side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 84 year old female, weighing 46.3 kg (101.8 pounds)

Reactions: Weight Decreased, Fatigue, Diarrhoea

Drug(s) suspected as cause:
Aranesp
    Dosage: 300 mug, q2wk
    Indication: Anaemia
    Start date: 2012-02-02

Revlimid
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Myelodysplastic Syndrome
    Start date: 2012-04-11

Other drugs received by patient: Vidaza



Possible Aranesp side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Aranesp
    Indication: Anaemia

Epogen
    Indication: Anaemia

Other drugs received by patient: Blood Cells; Chemotherapeutics; Blood Transfusion, Auxiliary Products



Possible Aranesp side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13

Patient: 30 year old male

Reactions: Haemoglobin Decreased

Drug(s) suspected as cause:
Aranesp
    Indication: Product Used FOR Unknown Indication

Eprex
    Dosage: 12000 iu, 3 times/wk

Eprex
    Dosage: 10000 iu, 3 times/wk



Possible Aranesp side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Ovarian Cancer Recurrent

Drug(s) suspected as cause:
Aranesp
    Indication: Anaemia

Procrit
    Indication: Anaemia

Other drugs received by patient: Blood Cells, Packed Human; Blood Transfusion, Auxiliary Products; Chemotherapeutics



Possible Aranesp side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13

Patient: 35 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Vomiting, Nausea, Pain, Headache

Drug(s) suspected as cause:
Aranesp
    Dosage: 30 mug, 2 times/wk
    Indication: Product Used FOR Unknown Indication

Eprex
    Dosage: 4000 unit, 3 times/wk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Rabeprazole Sodium; Metrocream; Diclofenac; Multi-Vitamins; Prednisone TAB; Venofer



Possible Aranesp side effects in

Reported by a physician from France on 2012-08-10

Patient:

Reactions: Anaemia

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10

Patient: 83 year old female

Reactions: Aplasia Pure RED Cell

Drug(s) suspected as cause:
Aranesp



Possible Aranesp side effects in 25 year old male

Reported by a physician from Finland on 2012-08-10

Patient: 25 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, non-Neutralising Antibodies Positive, Congestive Cardiomyopathy, Oropharyngeal Pain, Acne Cystic, Liver Disorder, Anti-Erythropoietin Antibody Positive, Aplasia Pure RED Cell, Cough, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: 150 mug, qwk
    Start date: 2011-06-03

Aranesp
    Dosage: unk
    Indication: Nephrogenic Anaemia
    Start date: 2003-01-01

Other drugs received by patient: Pratsiol; Metoprolol Succinate; Zemplar; Venotrix; Renvela; Disperin / 00002701 /; Blood and Related Products; Disperin / 00002701 /; Isotretinoin; Calcium Carbonate; Ramipril; Amlodipine Besylate; Renalvite; Gammaglobulin / 00025201 /; Cardace / 00574902 /; Metoprolol Succinate; Fragmin



Possible Aranesp side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 65 year old male, weighing 75.3 kg (165.6 pounds)

Reactions: Hypocalcaemia, Pancytopenia, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-03

Neulasta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-30
    End date: 2011-07-20

Xgeva
    Dosage: 120 mg, one time dose
    Indication: Metastases To Bone
    Start date: 2011-07-20
    End date: 2011-07-20

Other drugs received by patient: Kytril; Alimta; Avastin; Vitamin B12 / 00056201 /; Decadron



Possible Aranesp side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-09

Patient: 85 year old male

Reactions: Fall

Adverse event resulted in: death

Drug(s) suspected as cause:
Aranesp

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