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Benefix (Coagulation Factor IX) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Benefix (Coagulation Factor IX) 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 (112)
Death (6)
Life Threatening Events (6)

Reports by Reaction Type

Haemorrhage (12)Factor IX Inhibition (11)Hypersensitivity (10)Drug Ineffective (8)Anaphylactic Reaction (8)Epistaxis (8)Fall (7)Haemarthrosis (7)Headache (5)Rash Pruritic (5)Respiratory Arrest (5)Contusion (4)

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

Possible Benefix side effects in 14 year old male

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

Patient: 14 year old male, weighing 67.6 kg (148.7 pounds)

Reactions: Pain, Appendiceal Abscess, Appendicitis Perforated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix
    Dosage: 4000 iu, daily
    Start date: 2012-07-19

Benefix
    Dosage: 4000 iu, 2x/day
    Start date: 2012-07-16

Benefix
    Dosage: unk, as needed

Benefix
    Dosage: 6000 iu, as needed
    Indication: Factor IX Deficiency



Possible Benefix side effects in 66 year old male

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

Patient: 66 year old male, weighing 134.0 kg (294.8 pounds)

Reactions: Weight Decreased, Haemorrhage, Epistaxis

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, 2x/day

Benefix
    Dosage: 3000 iu, unk
    Indication: Factor IX Deficiency

Benefix
    Dosage: 3000 iu, 2x/day

Benefix
    Dosage: 6000 iu, 2x/day (for 3 days)
    Start date: 2010-01-01
    End date: 2010-01-01

Other drugs received by patient: Loratadine



Possible Benefix side effects in 15 year old male

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

Patient: 15 year old male, weighing 53.1 kg (116.7 pounds)

Reactions: Haemarthrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 65 year old male

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

Patient: 65 year old male, weighing 133.0 kg (292.6 pounds)

Reactions: Epistaxis

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, 2x/day
    Indication: Factor IX Deficiency

Mononine
    Dosage: unk
    Indication: Factor IX Deficiency
    End date: 2010-01-01

Benefix
    Dosage: 6000 iu, 2x/day (3 days)
    Start date: 2010-01-01

Benefix
    Dosage: 3000 iu, 2x/day
    Start date: 2010-01-01



Possible Benefix side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-14

Patient: 62 year old male, weighing 62.0 kg (136.4 pounds)

Reactions: Drug Ineffective, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 3 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 3 year old male

Reactions: Factor IX Inhibition

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 37 year old male

Reactions: Bronchitis

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

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

Patient: male

Reactions: Bronchitis

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 3 year old male

Reported by a physician from Japan on 2012-07-31

Patient: 3 year old male

Reactions: Factor IX Inhibition

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: male, weighing 68.9 kg (151.7 pounds)

Reactions: Pain, Abscess, Appendicitis Perforated

Drug(s) suspected as cause:
Benefix
    Dosage: 4000 iu, 2x/day
    Start date: 2012-07-16

Benefix
    Dosage: 4000 iu, daily
    Start date: 2012-07-19

Benefix
    Dosage: 6000 iu, unk
    Indication: Factor IX Deficiency



Possible Benefix side effects in 29 year old male

Reported by a physician from Belgium on 2012-07-31

Patient: 29 year old male, weighing 67.5 kg (148.5 pounds)

Reactions: Factor IX Inhibition

Drug(s) suspected as cause:
Benefix
    Dosage: unspecified dose increase
    Start date: 2007-10-24

Benefix
    Dosage: 3000 iu, 3x/wk
    Indication: Factor IX Deficiency
    Start date: 2005-01-13
    End date: 2007-10-23



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male

Reactions: Epistaxis

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, weekly

Benefix
    Dosage: unk
    Indication: Factor IX Deficiency
    Start date: 2007-01-01



Possible Benefix side effects in 10 month old male

Reported by a physician from Germany on 2012-07-16

Patient: 10 month old male, weighing 9.9 kg (21.8 pounds)

Reactions: Factor IX Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix
    Dosage: 250 iu/kg, 1x/day
    Indication: Factor IX Deficiency
    Start date: 2012-02-07

Benefix
    Dosage: 100 iu/kg, 1x/day



Possible Benefix side effects in 15 month old male

Reported by a physician from Germany on 2012-07-06

Patient: 15 month old male

Reactions: Factor IX Inhibition

Drug(s) suspected as cause:
Benefix
    Dosage: as needed
    Indication: Factor IX Deficiency
    Start date: 2012-01-01

Benefix
    Dosage: 1250 iu (750 iu and 500 iu), 1x/day
    Start date: 2012-06-01



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: male

Reactions: Arthropathy, Haemarthrosis, Haemorrhage

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: male

Reactions: Excoriation, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: female

Reactions: Haemorrhage

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: male, weighing 35.4 kg (77.8 pounds)

Reactions: Contusion, Headache, Fall, Groin Pain, Pituitary Cyst, Dizziness, Eye Allergy, Blood Pressure Abnormal, Sinusitis, Ultrasound Scan Abnormal, Clavicle Fracture, Self Injurious Behaviour, Migraine With Aura, Eye Pain, Anxiety, Syncope, Suicide Attempt, Cerebral Cyst

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: male, weighing 95.2 kg (209.5 pounds)

Reactions: Prostatic Specific Antigen Increased, Prostate Cancer, Haemarthrosis, Ulcer, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Benefix
    Dosage: 4000 iu, daily
    Indication: Factor IX Deficiency
    Start date: 1997-01-01

Benefix
    Dosage: 5000 iu, daily
    Start date: 2012-06-19

Benefix
    Dosage: 4000 iu, daily
    Start date: 2012-06-01



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: male, weighing 53.1 kg (116.7 pounds)

Reactions: Haemarthrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient:

Reactions: Haemorrhage

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male, weighing 133.8 kg (294.3 pounds)

Reactions: Weight Decreased, Haemorrhage, Epistaxis

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, unk
    Indication: Factor IX Deficiency

Benefix
    Dosage: 3000 iu, 2x/day

Benefix
    Dosage: 3000 iu, 2x/day

Benefix
    Dosage: 6000 iu, 2x/day (for 3 days)
    Start date: 2010-01-01
    End date: 2010-01-01



Possible Benefix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: male, weighing 133.8 kg (294.4 pounds)

Reactions: Epistaxis

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, 2x/day
    Indication: Factor IX Deficiency

Benefix
    Dosage: 3000 iu, 2x/day
    Start date: 2010-01-01

Mononine
    Dosage: unk
    Indication: Factor IX Deficiency
    End date: 2010-01-01

Benefix
    Dosage: 6000 iu, 2x/day (3 days)
    Start date: 2010-01-01



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-06

Patient: male

Reactions: Arthropathy

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06

Patient: male

Reactions: Scratch, Contusion, Haemorrhage

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: male

Reactions: Back Pain, Arthralgia

Drug(s) suspected as cause:
Opana
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Back Pain
    End date: 2012-04-01

Benefix
    Dosage: 3000 iu, 3 times a week
    Indication: Factor IX Deficiency

Opana
    Indication: Arthralgia

Other drugs received by patient: Allopurinol; Metformin; Colchicine; Imitrex; Trental; Celex; Neurontin; Ambien; Simvastatin; Lasix; Insulin; Naprosyn; Bactrim



Possible Benefix side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29

Patient: male, weighing 127.0 kg (279.4 pounds)

Reactions: Arthritis Infective, Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: male, weighing 10.0 kg (21.9 pounds)

Reactions: Malaise, Vomiting, Haemorrhage, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: male

Reactions: Contusion, Ultrasound Scan Abnormal, Clavicle Fracture, Self Injurious Behaviour, Headache, Fall, Groin Pain, Eye Pain, Migraine With Aura, Pituitary Cyst, Suicide Attempt, Dizziness, Eye Allergy, Cerebral Cyst, Sinusitis

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: male

Reactions: Intervertebral Disc Protrusion, Aphagia, Weight Decreased, Muscular Weakness, Nerve Compression, Small Cell Lung Cancer Stage Unspecified, Intervertebral Disc Calcification, Gait Disturbance

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Benefix

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