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Advate (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 Advate (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 (77)
Death (15)

Reports by Reaction Type

Factor Viii Inhibition (33)Device Related Infection (8)Headache (5)Pyrexia (5)Death (4)Malaise (4)Cyanosis (4)Gingival Bleeding (4)Condition Aggravated (4)Movement Disorder (3)Cerebral Haemorrhage (3)Muscle Haemorrhage (3)

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

Possible Advate side effects in 79 year old male

Reported by a physician from Japan on 2012-08-22

Patient: 79 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Advate

Other drugs received by patient: NEO-Minophagen C



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-18

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Humerus Fracture, Haemarthrosis, Post Procedural Complication, Gynaecomastia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Start date: 1999-04-01

Recombinate
    Start date: 1999-04-01



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: male, weighing 20.9 kg (46.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Indication: Factor Viii Inhibition
    Start date: 2010-06-01

Advate
    Start date: 2009-10-01
    End date: 2012-01-01

Advate
    Indication: Immune Tolerance Induction
    Start date: 2012-05-01

Advate
    Start date: 2012-06-01

Advate
    Start date: 2011-09-01

Recombinate
    Indication: Factor Viii Inhibition

Other drugs received by patient: Novoseven



Possible Advate side effects in male

Reported by a consumer/non-health professional from Colombia on 2012-08-14

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Gingival Bleeding, Vomiting, Diarrhoea, Faeces Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-13

Patient: male

Reactions: Malaise, Vomiting, Neck Pain, Nausea, Device Related Infection, Pyrexia

Drug(s) suspected as cause:
Advate
    Start date: 2010-01-01

Advate
    Start date: 2010-01-01



Possible Advate side effects in male

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

Patient: male, weighing 20.9 kg (46.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Indication: Immune Tolerance Induction
    Start date: 2012-05-01

Advate
    Start date: 2009-10-01
    End date: 2012-01-01

Advate
    Indication: Factor Viii Inhibition

Recombinate
    Indication: Factor Viii Inhibition

Other drugs received by patient: Novoseven



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Dosage: 1639 units
    Start date: 2004-01-01

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01

Novoseven



Possible Advate side effects in male

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

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Osteochondrosis, Factor Viii Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Start date: 2011-06-01
    End date: 2012-07-04

Advate
    Start date: 2006-10-01



Possible Advate side effects in 19 year old male

Reported by a physician from Germany on 2012-07-23

Patient: 19 year old male

Reactions: Renal Haemorrhage

Drug(s) suspected as cause:
Advate
    Start date: 2012-02-06

Advate
    Start date: 2012-02-03

Advate
    Indication: Prophylaxis
    Start date: 2012-02-01

Advate
    Start date: 2012-02-08

Other drugs received by patient: Advate



Possible Advate side effects in male

Reported by a physician from Japan on 2012-07-23

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Abdominal Pain, Headache, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Indication: Haemostasis
    Start date: 2010-05-26
    End date: 2012-06-03

Advate
    Start date: 2012-06-04
    End date: 2012-06-04

Advate
    Indication: Haemostasis
    Start date: 2010-05-26
    End date: 2012-06-03

Advate
    Dosage: unknown
    Start date: 2007-05-18
    End date: 2010-05-25

Advate
    Dosage: unknown
    Start date: 2007-05-18
    End date: 2010-05-25



Possible Advate side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-20

Patient: 5 year old male

Reactions: Staphylococcal Infection, Chills, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: male, weighing 20.9 kg (46.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Indication: Immune Tolerance Induction
    Start date: 2012-05-01

Advate
    Start date: 2009-10-01
    End date: 2012-01-01

Advate
    Indication: Factor Viii Inhibition

Recombinate
    Indication: Factor Viii Inhibition

Other drugs received by patient: Novoseven



Possible Advate side effects in male

Reported by a physician from Germany on 2012-07-18

Patient: male

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Advate
    Dosage: 1639 units
    Start date: 2004-01-01

Novoseven



Possible Advate side effects in male

Reported by a physician from Japan on 2012-07-12

Patient: male, weighing 10.3 kg (22.7 pounds)

Reactions: Fatigue, Hypophagia, Pyrexia, Factor Viii Inhibition, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Start date: 2012-04-24
    End date: 2012-04-24

Advate
    Start date: 2012-05-15
    End date: 2012-05-15

Advate
    Start date: 2012-04-27
    End date: 2012-05-03

Advate
    Start date: 2012-03-19
    End date: 2012-04-23

Advate
    Start date: 2012-05-17
    End date: 2012-05-18

Advate
    Start date: 2012-05-07
    End date: 2012-05-07

Other drugs received by patient: Diphtheria, Tetanu and Pertussis Adsorbed VA; Diphtheria, Tetanu and Pertussis Adsorbed VA; Live Poliomyelitis Vaccine



Possible Advate side effects in

Reported by a physician from Germany on 2012-07-12

Patient: , weighing 92.0 kg (202.4 pounds)

Reactions: Pelvic Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a physician from Colombia on 2012-07-12

Patient: male

Reactions: Movement Disorder, Back Pain, Gingival Bleeding, Headache, Pyrexia, Muscle Haemorrhage, Malaise, Cyanosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a physician from Japan on 2012-07-10

Patient: male, weighing 54.0 kg (118.8 pounds)

Reactions: Abdominal Pain, Headache, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Dosage: unknown
    Start date: 2007-05-18
    End date: 2010-05-25

Advate
    Dosage: unknown
    Start date: 2007-05-18
    End date: 2010-05-25

Advate
    Start date: 2012-06-04
    End date: 2012-06-04

Advate
    Indication: Haemostasis
    Start date: 2010-05-26
    End date: 2012-06-03

Advate
    Indication: Haemostasis
    Start date: 2010-05-26
    End date: 2012-06-03



Possible Advate side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection, Factor Viii Inhibition

Drug(s) suspected as cause:
Advate
    Dosage: 1639 units
    Start date: 2004-01-01

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01

Novoseven



Possible Advate side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male, weighing 20.9 kg (46.0 pounds)

Reactions: Device Related Infection, Factor Viii Inhibition

Drug(s) suspected as cause:
Advate

Advate
    Indication: Immune Tolerance Induction

Recombinate
    Indication: Factor Viii Inhibition

Other drugs received by patient: Novoseven



Possible Advate side effects in male

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

Patient: male

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Advate



Possible Advate side effects in

Reported by a pharmacist from United States on 2012-06-11

Patient:

Reactions: Post Procedural Infection

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-05-31

Patient: male

Reactions: Movement Disorder, Back Pain, Gingival Bleeding, Pyrexia, Headache, Muscle Haemorrhage, Malaise, Cyanosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in 57 year old

Reported by a physician from Germany on 2012-05-22

Patient: 57 year old , weighing 92.0 kg (202.4 pounds)

Reactions: Spinal Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

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

Patient: male

Reactions: Movement Disorder, Back Pain, Gingival Bleeding, Headache, Pyrexia, Muscle Haemorrhage, Malaise, Cyanosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate



Possible Advate side effects in male

Reported by a physician from France on 2012-05-14

Patient: male

Reactions: Haemarthrosis, Factor Viii Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate
    Start date: 2012-03-14
    End date: 2012-03-15

Advate
    Start date: 2011-12-05
    End date: 2011-12-05



Possible Advate side effects in male

Reported by a individual with unspecified qualification from Japan on 2012-05-10

Patient: male, weighing 16.0 kg (35.2 pounds)

Reactions: Condition Aggravated, Factor Viii Inhibition

Drug(s) suspected as cause:
Advate
    Start date: 2008-10-01
    End date: 2008-10-01

Advate
    Dosage: 8.3 iu/kg/hour
    Start date: 2008-10-01
    End date: 2008-10-06

Advate
    Start date: 2008-10-07
    End date: 2008-10-10

Other drugs received by patient: Cefazolin



Possible Advate side effects in male

Reported by a physician from Spain on 2012-05-03

Patient: male

Reactions: Drug Ineffective, Factor Viii Inhibition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advate

Advate



Possible Advate side effects in male

Reported by a physician from Korea, Republic of on 2012-04-23

Patient: male, weighing 30.0 kg (66.0 pounds)

Reactions: Factor Viii Inhibition

Drug(s) suspected as cause:
Advate
    Start date: 2011-04-03
    End date: 2011-04-11

Advate
    Start date: 2011-05-18

Advate
    Start date: 2011-03-22
    End date: 2011-03-22

Advate
    Start date: 2011-01-12

Advate
    Start date: 2011-04-13
    End date: 2011-04-13

Advate
    Start date: 2011-03-31
    End date: 2011-03-31

Advate
    Start date: 2011-04-18
    End date: 2011-05-17



Possible Advate side effects in male

Reported by a physician from Japan on 2012-04-19

Patient: male

Reactions: Hepatic Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Advate

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