DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Epogen (Epoetin Alfa) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Epogen (Epoetin Alfa) 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 (343)
Death (13)
Life Threatening Events (8)

Reports by Reaction Type

Haemoglobin Decreased (63)Drug Ineffective (59)Therapeutic Response Decreased (55)Aplasia Pure RED Cell (40)Anaemia (36)Medication Error (34)Dyspnoea (20)Fatigue (19)Hospitalisation (16)Anti-Erythropoietin Antibody Positive (15)Vomiting (12)Hypotension (12)

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

Possible Epogen 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 Epogen 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 Epogen side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 52 year old male

Reactions: Renal Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Menstruation Irregular, Abortion Induced, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen 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 Epogen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient:

Reactions: Haemoglobin Decreased, Aplasia Pure RED Cell

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Hypersensitivity, Urticaria, Blood Pressure Decreased

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in male

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

Patient: male

Reactions: Hypersensitivity, Urticaria, Blood Pressure Decreased

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 60 year old female

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

Patient: 60 year old female, weighing 72.6 kg (159.6 pounds)

Reactions: Therapeutic Response Decreased, Anaemia

Drug(s) suspected as cause:
Epogen
    Dosage: 20000 iu, qwk
    Start date: 2012-05-11

Epogen
    Dosage: 20000 iu/ml, unk

Epogen
    Dosage: 10000 iu/kg, qwk
    Start date: 2011-07-01

Epogen
    Dosage: 4000 iu, qwk
    Indication: Renal Failure Chronic
    Start date: 2010-05-17

Other drugs received by patient: Klonopin; Dialyvite with Zinc; Zemplar; Sensipar; Lyrica; Ultram; Coreg; Zyloprim; Renvela; Capoten; Pravachol; Renvela



Possible Epogen side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Menstruation Irregular, Abortion Induced, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen 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 Epogen side effects in male

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

Patient: male

Reactions: Blood Iron Decreased, Haemoglobin Decreased, Meningioma Benign, Myasthenia Gravis, Depressed Mood, Mobility Decreased

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in female

Reported by a physician from United States on 2012-08-09

Patient: female

Reactions: Drug Ineffective, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen
    Indication: Renal Failure Chronic

Epogen
    Dosage: 25000 iu, 3 times/wk
    Indication: Anaemia
    Start date: 2006-01-01



Possible Epogen side effects in 47 year old male

Reported by a physician from United States on 2012-08-09

Patient: 47 year old male

Reactions: Haemoglobin Decreased, Hospitalisation, Aplasia Pure RED Cell, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen
    Dosage: unk
    Indication: Anaemia

Epogen
    Indication: Haemodialysis

Epogen
    Indication: Renal Failure Chronic



Possible Epogen side effects in

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

Patient:

Reactions: Therapeutic Response Decreased, Renal Transplant

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Pancytopenia, Bone Marrow Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 59 year old male

Reported by a physician from United States on 2012-08-06

Patient: 59 year old male, weighing 106.0 kg (233.2 pounds)

Reactions: Haemoglobin Decreased, Localised Infection, Fatigue, Dyspnoea, Drug Ineffective, LEG Amputation, Transferrin Saturation Decreased, Serum Ferritin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Dosage: 200 mcg, qwk
    Indication: Renal Failure Chronic
    Start date: 2011-10-12
    End date: 2012-01-30

Epogen
    Dosage: 115000 units, qwk
    Start date: 2012-02-15
    End date: 2012-06-29

Epogen
    Dosage: unk unk, qwk
    Indication: Renal Failure Chronic
    Start date: 2010-03-15
    End date: 2011-01-13

Epogen
    Dosage: 20000 units, qd
    Start date: 2012-01-30
    End date: 2012-02-15



Possible Epogen side effects in 30 year old female

Reported by a physician from United States on 2012-08-02

Patient: 30 year old female

Reactions: Menstruation Irregular, Abortion Induced, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Blood Pressure Increased, Metamorphopsia, Intraocular Pressure Increased, Blindness Transient

Drug(s) suspected as cause:
Epogen

Other drugs received by patient: Toprol-XL; Lisinopril; Heparin



Possible Epogen side effects in male

Reported by a physician from United States on 2012-07-31

Patient: male

Reactions: Blood Iron Decreased, Haemoglobin Abnormal, Serum Ferritin Increased, Blister

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen

Other drugs received by patient: Iron; Prednisone



Possible Epogen side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Epogen
    Dosage: 11000 iu, 3 times/wk
    Indication: Dialysis
    Start date: 2011-01-01

Epogen
    Dosage: 23100 iu, 3 times/wk

Sensipar
    Dosage: 180 mg, qd
    Indication: Hyperparathyroidism Secondary

Other drugs received by patient: Atenolol; Renvela; Hectorol; Venofer; Sertraline Hydrochloride



Possible Epogen side effects in male

Reported by a physician from United States on 2012-07-26

Patient: male

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Epogen

Other drugs received by patient: Renvela; Hectorol; Cardizem; Sertraline Hydrochloride; Coreg; Clonidine; Docusate Sodium; Miralax / 00754501 /; Venofer; Minoxidil



Possible Epogen side effects in 53 year old female

Reported by a physician from United States on 2012-07-26

Patient: 53 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Drug Ineffective, Aplasia Pure RED Cell, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen
    Dosage: 20000 iu, qwk
    Indication: Peritoneal Dialysis
    Start date: 2012-05-01

Epogen
    Dosage: 20000 iu, 2 times/wk
    Indication: Anaemia
    Start date: 2012-06-01
    End date: 2012-06-27

Procrit
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-09-01

Other drugs received by patient: Renvela; Prednisone; Cephalosporin C; Diltiazem; Hectorol



Possible Epogen side effects in 3 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 3 year old male

Reactions: Haemoglobin Decreased, Haematocrit Decreased, Anti-Erythropoietin Antibody Positive, Blood Erythropoietin Decreased, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Reticulocyte Count Abnormal

Drug(s) suspected as cause:
Epogen
    Dosage: 10000 iu, 5 times/wk
    Indication: Dialysis
    Start date: 2011-10-18

Epogen
    Start date: 2011-10-01

Epogen
    Dosage: 3000 iu, 3 times/wk
    Start date: 2011-08-12

Epogen
    Dosage: 2400 iu, 2 times/wk
    Start date: 2010-10-01

Other drugs received by patient: Calcitriol; Nephrovite; Clonidine; Norvasc; Calcium Carbonate; Ferrous Sulfate TAB; Ergocalciferol; Prilosec; Enalapril Maleate; Prilosec



Possible Epogen side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Vomiting, Nausea, Hypotension, Unresponsive To Stimuli, Drug Hypersensitivity, Pallor, Hyperhidrosis, Blood Glucose Decreased, Incontinence, Malaise, Feeling Hot, Pulse Absent, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Vomiting, Nausea, Drug Hypersensitivity, Hypotension, Unresponsive To Stimuli, Pallor, Hyperhidrosis, Blood Glucose Decreased, Malaise, Incontinence, Feeling Hot, Pulse Absent, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 32 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: 32 year old male

Reactions: Haemoglobin Decreased, Blood Iron Decreased, Device Related Infection, Arteriovenous Fistula Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen



Possible Epogen side effects in 53 year old female

Reported by a physician from United States on 2012-07-19

Patient: 53 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Drug Ineffective, Aplasia Pure RED Cell, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epogen
    Dosage: 20000 iu, qwk
    Indication: Peritoneal Dialysis
    Start date: 2012-05-01

Epogen
    Dosage: 20000 iu, 2 times/wk
    Indication: Anaemia
    Start date: 2012-06-01
    End date: 2012-06-27

Epogen

Procrit
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-09-01

Other drugs received by patient: Hectorol; Diltiazem; Prednisone; Renvela; Cephalosporin C



Possible Epogen side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female

Reactions: Drug Ineffective, Urticaria, Anaemia, Bacterial Sepsis

Drug(s) suspected as cause:
Epogen

Other drugs received by patient: Antibiotics

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017