This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Benefix (Coagulation Factor IX) 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 (112)
Death (6)
Life Threatening Events (6)
Reports by Reaction Type
Haemorrhage (12),
Factor IX Inhibition (11),
Hypersensitivity (10),
Drug Ineffective (8),
Anaphylactic Reaction (8),
Epistaxis (8),
Fall (7),
Haemarthrosis (7),
Headache (5),
Rash Pruritic (5),
Respiratory Arrest (5),
Contusion (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Benefix (Coagulation Factor IX). For a complete list or a specific selection of reports, please use the links above.
Possible Benefix side effects in 14 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 14 year old male, weighing 67.6 kg (148.7 pounds)
Reactions: Pain, Appendiceal Abscess, Appendicitis Perforated
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Dosage: 4000 iu, daily
Start date: 2012-07-19
Benefix
Dosage: 4000 iu, 2x/day
Start date: 2012-07-16
Benefix
Dosage: unk, as needed
Benefix
Dosage: 6000 iu, as needed
Indication: Factor IX Deficiency
Possible Benefix side effects in 66 year old male
Reported by a physician from United States on 2012-08-27
Patient: 66 year old male, weighing 134.0 kg (294.8 pounds)
Reactions: Weight Decreased, Haemorrhage, Epistaxis
Drug(s) suspected as cause:
Benefix
Dosage: 3000 iu, 2x/day
Benefix
Dosage: 3000 iu, unk
Indication: Factor IX Deficiency
Benefix
Dosage: 3000 iu, 2x/day
Benefix
Dosage: 6000 iu, 2x/day (for 3 days)
Start date: 2010-01-01
End date: 2010-01-01
Other drugs received by patient: Loratadine
Possible Benefix side effects in 15 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 15 year old male, weighing 53.1 kg (116.7 pounds)
Reactions: Haemarthrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in 65 year old male
Reported by a physician from United States on 2012-08-24
Patient: 65 year old male, weighing 133.0 kg (292.6 pounds)
Reactions: Epistaxis
Drug(s) suspected as cause:
Benefix
Dosage: 3000 iu, 2x/day
Indication: Factor IX Deficiency
Mononine
Dosage: unk
Indication: Factor IX Deficiency
End date: 2010-01-01
Benefix
Dosage: 6000 iu, 2x/day (3 days)
Start date: 2010-01-01
Benefix
Dosage: 3000 iu, 2x/day
Start date: 2010-01-01
Possible Benefix side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-14
Patient: 62 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Drug Ineffective, Cerebral Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in 3 year old male
Reported by a physician from Japan on 2012-08-14
Patient: 3 year old male
Reactions: Factor IX Inhibition
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in 37 year old male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 37 year old male
Reactions: Bronchitis
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: male
Reactions: Bronchitis
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in 3 year old male
Reported by a physician from Japan on 2012-07-31
Patient: 3 year old male
Reactions: Factor IX Inhibition
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient: male, weighing 68.9 kg (151.7 pounds)
Reactions: Pain, Abscess, Appendicitis Perforated
Drug(s) suspected as cause:
Benefix
Dosage: 4000 iu, 2x/day
Start date: 2012-07-16
Benefix
Dosage: 4000 iu, daily
Start date: 2012-07-19
Benefix
Dosage: 6000 iu, unk
Indication: Factor IX Deficiency
Possible Benefix side effects in 29 year old male
Reported by a physician from Belgium on 2012-07-31
Patient: 29 year old male, weighing 67.5 kg (148.5 pounds)
Reactions: Factor IX Inhibition
Drug(s) suspected as cause:
Benefix
Dosage: unspecified dose increase
Start date: 2007-10-24
Benefix
Dosage: 3000 iu, 3x/wk
Indication: Factor IX Deficiency
Start date: 2005-01-13
End date: 2007-10-23
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: male
Reactions: Epistaxis
Drug(s) suspected as cause:
Benefix
Dosage: 3000 iu, weekly
Benefix
Dosage: unk
Indication: Factor IX Deficiency
Start date: 2007-01-01
Possible Benefix side effects in 10 month old male
Reported by a physician from Germany on 2012-07-16
Patient: 10 month old male, weighing 9.9 kg (21.8 pounds)
Reactions: Factor IX Inhibition
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Dosage: 250 iu/kg, 1x/day
Indication: Factor IX Deficiency
Start date: 2012-02-07
Benefix
Dosage: 100 iu/kg, 1x/day
Possible Benefix side effects in 15 month old male
Reported by a physician from Germany on 2012-07-06
Patient: 15 month old male
Reactions: Factor IX Inhibition
Drug(s) suspected as cause:
Benefix
Dosage: as needed
Indication: Factor IX Deficiency
Start date: 2012-01-01
Benefix
Dosage: 1250 iu (750 iu and 500 iu), 1x/day
Start date: 2012-06-01
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male
Reactions: Arthropathy, Haemarthrosis, Haemorrhage
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male
Reactions: Excoriation, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: female
Reactions: Haemorrhage
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: male, weighing 35.4 kg (77.8 pounds)
Reactions: Contusion, Headache, Fall, Groin Pain, Pituitary Cyst, Dizziness, Eye Allergy, Blood Pressure Abnormal, Sinusitis, Ultrasound Scan Abnormal, Clavicle Fracture, Self Injurious Behaviour, Migraine With Aura, Eye Pain, Anxiety, Syncope, Suicide Attempt, Cerebral Cyst
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: male, weighing 95.2 kg (209.5 pounds)
Reactions: Prostatic Specific Antigen Increased, Prostate Cancer, Haemarthrosis, Ulcer, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Benefix
Dosage: 4000 iu, daily
Indication: Factor IX Deficiency
Start date: 1997-01-01
Benefix
Dosage: 5000 iu, daily
Start date: 2012-06-19
Benefix
Dosage: 4000 iu, daily
Start date: 2012-06-01
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: male, weighing 53.1 kg (116.7 pounds)
Reactions: Haemarthrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient:
Reactions: Haemorrhage
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: male, weighing 133.8 kg (294.3 pounds)
Reactions: Weight Decreased, Haemorrhage, Epistaxis
Drug(s) suspected as cause:
Benefix
Dosage: 3000 iu, unk
Indication: Factor IX Deficiency
Benefix
Dosage: 3000 iu, 2x/day
Benefix
Dosage: 3000 iu, 2x/day
Benefix
Dosage: 6000 iu, 2x/day (for 3 days)
Start date: 2010-01-01
End date: 2010-01-01
Possible Benefix side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: male, weighing 133.8 kg (294.4 pounds)
Reactions: Epistaxis
Drug(s) suspected as cause:
Benefix
Dosage: 3000 iu, 2x/day
Indication: Factor IX Deficiency
Benefix
Dosage: 3000 iu, 2x/day
Start date: 2010-01-01
Mononine
Dosage: unk
Indication: Factor IX Deficiency
End date: 2010-01-01
Benefix
Dosage: 6000 iu, 2x/day (3 days)
Start date: 2010-01-01
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: male
Reactions: Arthropathy
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06
Patient: male
Reactions: Scratch, Contusion, Haemorrhage
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: male
Reactions: Back Pain, Arthralgia
Drug(s) suspected as cause:
Opana
Dosage: 20 mg, 3x/day
Administration route: Oral
Indication: Back Pain
End date: 2012-04-01
Benefix
Dosage: 3000 iu, 3 times a week
Indication: Factor IX Deficiency
Opana
Indication: Arthralgia
Other drugs received by patient: Allopurinol; Metformin; Colchicine; Imitrex; Trental; Celex; Neurontin; Ambien; Simvastatin; Lasix; Insulin; Naprosyn; Bactrim
Possible Benefix side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29
Patient: male, weighing 127.0 kg (279.4 pounds)
Reactions: Arthritis Infective, Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: male, weighing 10.0 kg (21.9 pounds)
Reactions: Malaise, Vomiting, Haemorrhage, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-21
Patient: male
Reactions: Contusion, Ultrasound Scan Abnormal, Clavicle Fracture, Self Injurious Behaviour, Headache, Fall, Groin Pain, Eye Pain, Migraine With Aura, Pituitary Cyst, Suicide Attempt, Dizziness, Eye Allergy, Cerebral Cyst, Sinusitis
Drug(s) suspected as cause:
Benefix
Possible Benefix side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: male
Reactions: Intervertebral Disc Protrusion, Aphagia, Weight Decreased, Muscular Weakness, Nerve Compression, Small Cell Lung Cancer Stage Unspecified, Intervertebral Disc Calcification, Gait Disturbance
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Benefix
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