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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