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Procrit (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 Procrit (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 (405)
Death (43)
Life Threatening Events (5)
Disability (3)

Reports by Reaction Type

Haemoglobin Decreased (69)Therapeutic Response Decreased (50)Aplasia Pure RED Cell (48)Anaemia (46)Fatigue (31)Drug Ineffective (29)Hospitalisation (22)Asthenia (22)Anti-Erythropoietin Antibody Positive (20)Dyspnoea (19)Injection Site Pain (17)Pain (16)

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

Possible Procrit side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 72 year old male

Reactions: Death, Heart Rate Increased, Lung Neoplasm Malignant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-16
    End date: 2009-01-01

Procrit
    Dosage: unk



Possible Procrit side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 66 year old female, weighing 76.6 kg (168.6 pounds)

Reactions: Diabetes Mellitus, Anaemia, Coronary Artery Occlusion, Alopecia, Blood Count Abnormal, Iron Overload

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit



Possible Procrit side effects in female

Reported by a pharmacist from United States on 2012-08-24

Patient: female

Reactions: Vomiting

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit



Possible Procrit side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 72 year old male

Reactions: Heart Rate Increased, Lung Carcinoma Cell Type Unspecified Stage IV

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk unk, 2 times/wk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-16

Procrit
    Dosage: unk

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Procrit side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 72 year old male

Reactions: Death, Heart Rate Increased, Lung Neoplasm Malignant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-16
    End date: 2009-01-01

Procrit
    Dosage: unk



Possible Procrit side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Glaucoma, Dyspnoea

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 120 microgram, unknown
    End date: 2012-07-13

Procrit
    Dosage: 1 ml, qw
    End date: 2012-07-13

Rebetol
    Dosage: 200 mg, unknown
    Administration route: Oral
    End date: 2012-07-13



Possible Procrit side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 84 year old female, weighing 48.1 kg (105.8 pounds)

Reactions: Pelvic Fracture, Dyspnoea, Abasia, Fall, Injection Site Pruritus, Tremor, Haemoglobin Decreased, Injection Site Erythema, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit
    Dosage: 10 iu, q2wk
    Indication: Anaemia
    Start date: 2010-01-01

Procrit
    Dosage: 20 iu, q2wk



Possible Procrit side effects in female

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

Patient: female

Reactions: Squamous Cell Carcinoma, Anaemia

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Aranesp



Possible Procrit side effects in 78 year old male

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

Patient: 78 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Emphysema, Pneumonia, Drug Ineffective, Arteriosclerosis Coronary Artery, Myocardial Infarction, Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit
    Dosage: 30000 iu, unk

Procrit
    Dosage: 20000 iu, unk
    Indication: Myelodysplastic Syndrome
    Start date: 2011-01-01
    End date: 2012-07-01



Possible Procrit side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Haemoglobin Decreased, Incorrect Route of Drug Administration, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit



Possible Procrit side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 82 year old female

Reactions: Pneumonia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Albumin
    Dosage: unk
    Start date: 2010-01-01

Lasix
    Dosage: unk
    Start date: 2010-01-01

Levaquin
    Dosage: unk
    Start date: 2008-01-01

Procrit
    Dosage: 20000 iu, one time dose
    Indication: Anaemia
    Start date: 2010-05-22
    End date: 2010-05-22



Possible Procrit side effects in 60 year old female

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

Patient: 60 year old female, weighing 51.7 kg (113.7 pounds)

Reactions: Migraine, Haemoglobin Abnormal, Abnormal Loss of Weight, Rash

Drug(s) suspected as cause:
Neupogen
    Dosage: 300 mug, qwk
    Indication: Anaemia
    Start date: 2011-12-01

Procrit
    Dosage: 40000 iu, qwk
    Indication: Anaemia
    Start date: 2012-01-01

Other drugs received by patient: Ribavirin; Imitrex; Ritalin



Possible Procrit side effects in female

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

Patient: female

Reactions: Thrombosis, RED Blood Cell Count Decreased

Adverse event resulted in: hospitalization

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

Rituxan
    Indication: Rheumatoid Arthritis



Possible Procrit 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 Procrit side effects in female

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

Patient: female

Reactions: Procedural Haemorrhage, Anaemia

Drug(s) suspected as cause:
Procrit
    Dosage: 22000 iu, unk
    Start date: 2012-08-02
    End date: 2012-08-02

Procrit
    Dosage: unk
    Indication: Preoperative Care
    Start date: 2012-07-25
    End date: 2012-07-25



Possible Procrit side effects in 61 year old female

Reported by a physician from United States on 2012-08-10

Patient: 61 year old female, weighing 70.3 kg (154.6 pounds)

Reactions: Fatigue, Palpitations, Anaemia, Gait Disturbance, Venous Thrombosis Limb, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Metformin Hydrochloride



Possible Procrit side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Pneumonia, Tendon Rupture, Anaemia, Rotator Cuff Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Albumin (Human)
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Lasix
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Procrit
    Dosage: 20,000 units/ solution
    Indication: Anaemia
    Start date: 2010-05-22
    End date: 2010-05-22



Possible Procrit side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Anti-Erythropoietin Antibody Positive, Neutralising Antibodies Positive, Aplasia Pure RED Cell, Varices Oesophageal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Interferon; Cyanocobalamin; Ribavirin



Possible Procrit side effects in 62 year old female

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

Patient: 62 year old female

Reactions: Drug Eruption, White Blood Cell Count Decreased, Contusion, Dyspnoea, Anaemia, Oral Discomfort, Face Oedema, Fatigue, Blood Potassium Decreased, Alopecia, Platelet Count Decreased, Depression, Asthenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Incivek
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-13
    End date: 2012-04-03

Procrit
    Indication: Anaemia

Other drugs received by patient: Ribavirin; Pegasys; Ribavirin; Ribavirin



Possible Procrit side effects in 72 year old male

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

Patient: 72 year old male

Reactions: Death, Heart Rate Increased, Lung Neoplasm Malignant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-16
    End date: 2009-01-01

Procrit
    Dosage: unk



Possible Procrit side effects in 90 year old female

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

Patient: 90 year old female, weighing 78.5 kg (172.6 pounds)

Reactions: Hypersensitivity, Angioedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aranesp
    Indication: Myelodysplastic Syndrome

Procrit
    Dosage: 60000 unit, q2wk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-24
    End date: 2012-05-08



Possible Procrit side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: female

Reactions: Squamous Cell Carcinoma, Anaemia

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Aranesp



Possible Procrit side effects in 86 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 86 year old male, weighing 82.7 kg (181.9 pounds)

Reactions: Pneumonia, Abasia, Myocardial Ischaemia, Hypotension, Iron Deficiency, Blood Product Transfusion Dependent, Pyrexia, Osteoarthritis, Therapeutic Response Decreased, Haematocrit Decreased, Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit
    Dosage: 20000 iu, qwk
    Indication: Nephrogenic Anaemia
    Start date: 2011-07-01
    End date: 2012-04-01

Procrit
    Dosage: unk
    Start date: 2011-10-24

Other drugs received by patient: Iron



Possible Procrit side effects in female

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

Patient: female

Reactions: Malaise, Fatigue, Nausea, Incorrect Dose Administered, Anaemia, Tremor

Drug(s) suspected as cause:
Procrit



Possible Procrit side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male

Reactions: Blood Count Abnormal, Dizziness, Headache, Fall, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit
    Dosage: unk

Procrit
    Dosage: unk
    Indication: Anaemia
    Start date: 2011-11-01



Possible Procrit side effects in 91 year old female

Reported by a physician from United States on 2012-08-01

Patient: 91 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: HIP Fracture, Injection Site Pain, Fall, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Diuretic / 00022001 /; Hydralazine HCL; Amlodipine; Calcium; Antihypertensives; Potassium; Lasix; Plavix; Isosorbide Mononitrate



Possible Procrit side effects in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 53 year old male, weighing 68.6 kg (150.9 pounds)

Reactions: Lung Neoplasm Malignant, Metastases To Bone

Adverse event resulted in: death

Drug(s) suspected as cause:
Aranesp
    Dosage: 200 mug, q2wk
    Indication: Anaemia of Malignant Disease
    Start date: 2007-04-10
    End date: 2007-11-06

Neulasta
    Dosage: 6 mg, unk
    Start date: 2007-04-11
    End date: 2007-07-26

Procrit
    Dosage: unk unk, unk
    Start date: 2008-01-11
    End date: 2008-01-11

Other drugs received by patient: Unspecified Antineoplastic Agent



Possible Procrit side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Malignant Melanoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Procrit

Other drugs received by patient: Chemotherapeutics



Possible Procrit 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 Procrit side effects in 53 year old male

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

Patient: 53 year old male, weighing 68.6 kg (150.9 pounds)

Reactions: Lung Neoplasm Malignant, Metastases To Bone

Adverse event resulted in: death

Drug(s) suspected as cause:
Aranesp
    Dosage: 200 mug, q2wk
    Indication: Anaemia of Malignant Disease
    Start date: 2007-04-10
    End date: 2007-11-06

Neulasta
    Dosage: 6 mg, unk
    Start date: 2007-04-11
    End date: 2007-07-26

Procrit
    Dosage: unk unk, unk
    Start date: 2008-01-11
    End date: 2008-01-11

Other drugs received by patient: Unspecified Antineoplastic Agent

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