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Benefix (Coagulation Factor IX) - Hypersensitivity - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Hypersensitivity (10)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Benefix (Coagulation Factor IX) where reactions include hypersensitivity. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Benefix side effects in 16 year old female

Reported by a physician from Australia on 2012-04-27

Patient: 16 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Pruritus, Hypersensitivity, Paraesthesia Oral, Urticaria, Rash, Eye Pruritus, Rash Pruritic

Drug(s) suspected as cause:
Benefix
    Dosage: total cumulative dose of 28,500 units;9 exposure days and an estimated number of exposure days {20
    Indication: Factor IX Deficiency
    Start date: 2004-02-12

Benefix
    Dosage: 3000 iu, single
    Start date: 2011-11-01
    End date: 2011-11-01

Benefix
    Dosage: 3000 iu, single
    Indication: Dental Care
    Start date: 2011-11-15
    End date: 2011-11-15



Possible Benefix side effects in

Reported by a physician from United States on 2012-04-09

Patient:

Reactions: Viral Infection, Hypersensitivity

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in

Reported by a physician from United States on 2012-03-09

Patient:

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 16 year old female

Reported by a physician from Australia on 2012-01-30

Patient: 16 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Pruritus, Hypersensitivity, Paraesthesia Oral, Urticaria, Rash, Rash Pruritic, Eye Pruritus

Drug(s) suspected as cause:
Benefix
    Dosage: 3000 iu, single
    Indication: Dental Care
    Start date: 2011-11-15
    End date: 2011-11-15

Benefix
    Dosage: 3000 iu, single
    Start date: 2011-11-01
    End date: 2011-11-01

Benefix
    Dosage: total cumulative dose of 28,500 units;9 exposure days and an estimated number of exposure days {20
    Indication: Factor IX Deficiency
    Start date: 2004-02-12



Possible Benefix side effects in male

Reported by a physician from United States on 2012-01-30

Patient: male

Reactions: Hypersensitivity, Urticaria, Anaphylactic Reaction, Erythema

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in 5 year old male

Reported by a physician from France on 2012-01-24

Patient: 5 year old male, weighing 20.0 kg (44.0 pounds)

Reactions: Hypersensitivity, Chills, Feeling Cold

Drug(s) suspected as cause:
Benefix
    Dosage: 1000 iu, 1x/day, as needed
    Indication: Haematoma
    Start date: 2011-09-28
    End date: 2011-09-29

Benefix
    Dosage: 1000 iu, alternate day, as needed
    Start date: 2011-10-01
    End date: 2011-10-07



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Hypersensitivity, Rash Pruritic

Drug(s) suspected as cause:
Benefix
    Dosage: unk
    Indication: Factor IX Deficiency
    Start date: 2000-01-01

Benefix
    Dosage: 2000 iu, daily



Possible Benefix side effects in male

Reported by a physician from France on 2011-12-09

Patient: male

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Benefix



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-04

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Hypersensitivity, Rash Pruritic

Drug(s) suspected as cause:
Benefix
    Dosage: unk
    Indication: Factor IX Deficiency
    Start date: 2000-01-01

Benefix
    Dosage: 2000 iu, daily



Possible Benefix side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-01

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Hypersensitivity, Rash Pruritic

Drug(s) suspected as cause:
Benefix
    Dosage: 2000 iu, daily

Benefix
    Dosage: unk
    Indication: Factor IX Deficiency
    Start date: 2000-01-01

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