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Refacto (Antihemophilic Factor) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Refacto (Antihemophilic Factor) 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 (48)
Life Threatening Events (4)

Reports by Reaction Type

Factor Viii Inhibition (25)Anti Factor Viii Antibody Positive (13)Post Procedural Haemorrhage (9)Drug Ineffective (7)Haemorrhage (5)Hypersensitivity (4)Colitis Ulcerative (3)Somnolence (3)Abdominal Pain Upper (3)Fatigue (3)Intestinal Perforation (3)Intestinal Haemorrhage (3)

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

Possible Refacto side effects in 42 year old male

Reported by a physician from Germany on 2012-08-24

Patient: 42 year old male

Reactions: Inguinal Hernia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-08-13

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Ecchymosis, Post Procedural Haemorrhage, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-05
    End date: 2010-10-08

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-14
    End date: 2011-03-18

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-03-28
    End date: 2012-03-28

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-05
    End date: 2010-10-08

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-05



Possible Refacto side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-11

Patient: 5 year old male, weighing 17.5 kg (38.5 pounds)

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 25 year old male

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

Patient: 25 year old male

Reactions: Colitis Ulcerative, Drug Ineffective, Pain, Somnolence, Abdominal Pain Upper, Intestinal Haemorrhage, Intestinal Perforation, Fatigue, Arthralgia

Drug(s) suspected as cause:
Refacto

Other drugs received by patient: Acetaminophen W / Codeine; Morphine; Nexium



Possible Refacto side effects in 25 year old male

Reported by a consumer/non-health professional from Sweden on 2012-06-14

Patient: 25 year old male

Reactions: Intestinal Haemorrhage, Fatigue, Intestinal Perforation, Arthralgia, Drug Ineffective, Colitis Ulcerative, Somnolence, Abdominal Pain Upper

Drug(s) suspected as cause:
Refacto

Other drugs received by patient: Morphine



Possible Refacto side effects in 4 year old male

Reported by a consumer/non-health professional from Sweden on 2012-06-08

Patient: 4 year old male

Reactions: Mouth Haemorrhage, Anti Factor Viii Antibody Positive

Drug(s) suspected as cause:
Refacto
    Dosage: 2000 iu, 1x/day
    Start date: 2011-12-01

Refacto
    Dosage: 3000 iu, 1x/day
    Start date: 2010-05-01

Refacto
    Dosage: 500 iu, 1x/day
    Indication: Factor Viii Deficiency
    Start date: 2009-01-08



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-06-08

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Ecchymosis, Post Procedural Haemorrhage, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: unk
    Start date: 2010-10-01
    End date: 2010-11-10

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-05

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-05
    End date: 2010-10-08

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-05
    End date: 2010-10-08

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-03-28
    End date: 2012-03-28

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-14
    End date: 2011-03-18



Possible Refacto side effects in 26 year old male

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

Patient: 26 year old male

Reactions: Drug Ineffective, Colitis Ulcerative, Somnolence, Abdominal Pain Upper, Intestinal Haemorrhage, Intestinal Perforation, Fatigue, Arthralgia

Drug(s) suspected as cause:
Refacto

Other drugs received by patient: Morphine



Possible Refacto side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-05

Patient: 5 year old male, weighing 17.5 kg (38.5 pounds)

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 4 year old male

Reported by a consumer/non-health professional from Sweden on 2012-05-31

Patient: 4 year old male

Reactions: Anti Factor Viii Antibody Positive

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-05-23

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-07



Possible Refacto side effects in 13 month old male

Reported by a physician from France on 2012-05-17

Patient: 13 month old male, weighing 11.5 kg (25.3 pounds)

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-08

Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)

Reactions: Haemorrhage, Injury, Factor Viii Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 500 iu once weekly
    Indication: Factor Viii Deficiency
    Start date: 2011-04-01
    End date: 2011-11-09

Refacto
    Indication: Prophylaxis



Possible Refacto side effects in 4 year old male

Reported by a consumer/non-health professional from Sweden on 2012-05-03

Patient: 4 year old male

Reactions: Anti Factor Viii Antibody Positive

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 20 year old male

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

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-07

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-04-20

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-07

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01



Possible Refacto side effects in 20 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-16

Patient: 20 year old male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto
    Indication: Surgery

Refacto
    Dosage: as needed
    Indication: Haemorrhage

Refacto
    Indication: Haemophilia



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-03-29

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-07

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-03-23

Patient: 20 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 30 iu/kg, unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2012-02-03
    End date: 2012-02-07

Refacto
    Dosage: 30 iu/kg, single
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: 30 iu/kg, unk
    Start date: 2011-03-01
    End date: 2011-03-01



Possible Refacto side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-19

Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)

Reactions: Haemorrhage, Injury, Factor Viii Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Refacto
    Dosage: 500 iu once weekly
    Indication: Factor Viii Deficiency
    Start date: 2011-04-01
    End date: 2011-11-09

Refacto
    Indication: Prophylaxis



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-03-13

Patient: 20 year old male

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Drug(s) suspected as cause:
Refacto
    Dosage: unk
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: unk
    Start date: 2012-02-03
    End date: 2012-02-07

Refacto
    Dosage: unk
    Start date: 2012-02-15
    End date: 2012-02-16



Possible Refacto side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-13

Patient: 5 year old male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-07

Patient:

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 20 year old male

Reported by a physician from Portugal on 2012-03-07

Patient: 20 year old male

Reactions: Anti Factor Viii Antibody Positive, Post Procedural Haemorrhage

Drug(s) suspected as cause:
Refacto
    Dosage: unk
    Start date: 2011-03-01
    End date: 2011-03-01

Refacto
    Dosage: unk
    Indication: Haemorrhage Prophylaxis
    Start date: 2010-10-01
    End date: 2010-10-01

Refacto
    Dosage: unk
    Start date: 2012-02-15
    End date: 2012-02-16

Refacto
    Dosage: unk
    Start date: 2012-02-03
    End date: 2012-02-07



Possible Refacto side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06

Patient: male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06

Patient: male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06

Patient: male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-16

Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)

Reactions: Haemorrhage, Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto
    Dosage: 500 iu once weekly
    Indication: Factor Viii Deficiency
    Start date: 2011-04-01
    End date: 2011-11-09

Refacto
    Dosage: 750-1000 iu, 2x/week
    Indication: Prophylaxis
    Start date: 2011-11-09



Possible Refacto side effects in 9 year old male

Reported by a physician from United Kingdom on 2012-02-06

Patient: 9 year old male, weighing 45.0 kg (99.0 pounds)

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto



Possible Refacto side effects in 14 month old male

Reported by a physician from United Kingdom on 2012-02-01

Patient: 14 month old male

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Refacto
    Dosage: 3 doses (unknown units and frequency)
    Start date: 2011-06-01

Refacto
    Dosage: recurrent treatments (unknown units and frequencies)

Refacto
    Dosage: 1 dose (unknown units and frequency)
    Indication: Factor Viii Deficiency
    Start date: 2011-05-01

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