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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