This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Novoseven (Coagulation Factor VIIA) 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 (66)
Death (28)
Life Threatening Events (7)
Reports by Reaction Type
Haemorrhage (8),
Death (8),
Deep Vein Thrombosis (8),
Troponin I Increased (6),
Multi-Organ Failure (5),
Cerebral Infarction (5),
Abdominal Pain (4),
Drug Ineffective (4),
Disseminated Intravascular Coagulation (3),
Device Related Infection (3),
Bone Pain (2),
Foetal Exposure During Pregnancy (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Novoseven (Coagulation Factor VIIA). For a complete list or a specific selection of reports, please use the links above.
Possible Novoseven side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20
Patient: 77 year old male
Reactions: Ischaemic Stroke, Sensorimotor Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 5 mg, qd
Novoseven
Dosage: 2 mg/iv
Novoseven
Dosage: 5 mg, qd
Indication: Product Used FOR Unknown Indication
Novoseven
Dosage: 1 mg, qd
Other drugs received by patient: Nexium; Wilfactin; Prednisone TAB; Metformin HCL; Nicardipine HCL; Chondrosulf; Lovenox; Crestor; Fenofibrate Biogaran; Aspirin
Possible Novoseven side effects in 13 year old male
Reported by a physician from Germany on 2012-08-14
Patient: 13 year old male, weighing 47.3 kg (104.1 pounds)
Reactions: Back Pain, Abdominal Pain, Vomiting, Haematuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 8+5mg every second day
Indication: Factor Viii Deficiency
Start date: 2008-01-01
Novoseven
Dosage: 8+5mg every second day
Other drugs received by patient: Ibuprofen
Possible Novoseven side effects in female
Reported by a physician from United States on 2012-08-10
Patient: female, weighing 72.8 kg (160.2 pounds)
Reactions: Mitral Valve Disease, Mass, Tricuspid Valve Disease, Embolic Stroke, Bradycardia, Cardiac Arrest, Pulseless Electrical Activity
Adverse event resulted in: death
Drug(s) suspected as cause:
Novoseven
Possible Novoseven 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
Novoseven
Advate
Start date: 2004-02-01
End date: 2004-02-01
Advate
Indication: Factor Viii Inhibition
Start date: 2004-02-01
Possible Novoseven side effects in male
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-07-20
Patient: male
Reactions: Abdominal Pain, Haemorrhage, Pallor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
Start date: 2012-06-01
End date: 2012-06-27
Feiba
Dosage: 3000 ue per day
Start date: 2012-06-01
Feiba
Dosage: 3000 ue per day
Start date: 2012-07-04
Feiba
Dosage: 3000 ue per day
Start date: 2012-07-03
Possible Novoseven 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
Novoseven
Advate
Dosage: 1639 units
Start date: 2004-01-01
Possible Novoseven side effects in male
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-07-13
Patient: male
Reactions: Abdominal Pain, Haemorrhage, Pallor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Feiba 1000 U, Poudre ET Solvant Pour Solution Injectable
Dosage: 3000 ue per day
Start date: 2012-07-03
Novoseven
Possible Novoseven side effects in 13 year old male
Reported by a physician from Germany on 2012-07-09
Patient: 13 year old male, weighing 47.3 kg (104.1 pounds)
Reactions: Abdominal Pain, Back Pain, Vomiting, Haematuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 13 mg, unk
Novoseven
Dosage: 13 mg, unk
Indication: Factor Viii Deficiency
Start date: 2008-01-01
Other drugs received by patient: Ibuprofen
Possible Novoseven side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-09
Patient: 60 year old male
Reactions: Multi-Organ Failure, Left Ventricular Dysfunction, Haemorrhage, Disseminated Intravascular Coagulation, Aortic Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 90 ug
Indication: Product Used FOR Unknown Indication
Clopidogrel
Indication: Arterial Stenosis
Possible Novoseven 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:
Novoseven
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
Possible Novoseven side effects in 70 year old male
Reported by a physician from Switzerland on 2012-06-26
Patient: 70 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Cerebral Ischaemia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 31 mg, qd
Indication: Factor Viii Deficiency
Start date: 2012-05-23
Cyklokapron
Dosage: 2.5 g, qd
Administration route: Oral
Start date: 2012-05-27
Cyklokapron
Dosage: 1.5 g, qd
Administration route: Oral
Start date: 2012-05-28
End date: 2012-06-01
Novoseven
Dosage: 40 mg, qd
Start date: 2012-05-24
Cyklokapron
Dosage: 1 g, tid
Administration route: Oral
Indication: Haemorrhage
Start date: 2012-05-22
End date: 2012-05-26
Novoseven
Dosage: 19 mg, qd
Indication: Gastrointestinal Haemorrhage
Start date: 2012-05-22
Novoseven
Dosage: 21 mg, qd
Start date: 2012-05-25
Possible Novoseven side effects in 68 year old male
Reported by a physician from Italy on 2012-06-22
Patient: 68 year old male, weighing 100.0 kg (220.0 pounds)
Reactions: Cerebral Infarction, Troponin I Increased, Deep Vein Thrombosis
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 48 year old male
Reported by a physician from Italy on 2012-06-22
Patient: 48 year old male, weighing 150.0 kg (330.0 pounds)
Reactions: Troponin I Increased
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 74 year old female
Reported by a physician from Italy on 2012-06-22
Patient: 74 year old female
Reactions: Troponin I Increased, Deep Vein Thrombosis
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-19
Patient: 31 year old female
Reactions: Dialysis, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Bupivacaine Aguettant
Dosage: 10 mg, qd
Indication: Spinal Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Cefazolin
Dosage: once daily
Indication: Antibiotic Prophylaxis
Start date: 2012-01-08
End date: 2012-01-08
Clottafact
Dosage: 6 g, qd
Indication: Third Stage Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Sevoflurane
Dosage: unk
Indication: Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Novoseven
Dosage: 4 mg, qd
Indication: Third Stage Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Ephedrine
Dosage: 60 mg, qd
Indication: Spinal Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Tagamet
Dosage: 400 mg, qd
Indication: Spinal Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Pabal
Dosage: 100 a?g, qd
Indication: Uterine Atony
Start date: 2012-01-08
End date: 2012-01-08
Nalador
Dosage: 1000 a?g, qd
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-08
End date: 2012-01-08
Omeprazole
Dosage: 4 g, qd
Indication: Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Other drugs received by patient: Platelets, Concentrated; RED Blood Cells; Celocurine / 00057702 /; Diprivan; Phenylephrine HCL; Voluven; Fresh Frozen Plasma; Tracrium
Possible Novoseven side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-07
Patient: 31 year old female
Reactions: Dialysis, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 4 mg, qd
Indication: Third Stage Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Cefazolin
Dosage: once daily
Indication: Antibiotic Prophylaxis
Start date: 2012-01-08
End date: 2012-01-08
Ephedrine
Dosage: 60 mg, qd
Indication: Spinal Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Omeprazole
Dosage: 4 g, qd
Indication: Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Tagamet
Dosage: 400 mg, qd
Indication: Spinal Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Marcaine HCL
Dosage: 10 mg, qd
Indication: Spinal Anaesthesia
Sevoflurane
Dosage: unk
Indication: Anaesthesia
Start date: 2012-01-08
End date: 2012-01-08
Clottafact
Dosage: 6 g, qd
Indication: Third Stage Postpartum Haemorrhage
Start date: 2012-01-08
End date: 2012-01-08
Nalador
Dosage: 1000 a?g, qd
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-08
End date: 2012-01-08
Pabal
Dosage: 100 a?g, qd
Indication: Uterine Atony
Start date: 2012-01-08
End date: 2012-01-08
Other drugs received by patient: Celocurine / 00057702 /; Tracrium; Phenylephrine HCL; Fresh Frozen Plasma; Diprivan; RED Blood Cells; Voluven; Platelets, Concentrated
Possible Novoseven side effects in 60 year old male
Reported by a individual with unspecified qualification from France on 2012-05-31
Patient: 60 year old male
Reactions: Multi-Organ Failure, Left Ventricular Dysfunction, Postoperative Thrombosis, Haemorrhage, Disseminated Intravascular Coagulation, Aortic Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Novoseven
Dosage: 90 ug/kg
Indication: Product Used FOR Unknown Indication
Clopidegrel
Indication: Arterial Stenosis
Possible Novoseven side effects in 67 year old female
Reported by a physician from United States on 2012-05-02
Patient: 67 year old female, weighing 53.1 kg (116.8 pounds)
Reactions: Brain Death, Platelet Aggregation, Brain Herniation, Tachycardia, Unresponsive To Stimuli, Cerebellar Infarction, Cerebral Infarction, Cerebral Thrombosis, Hypertension
Adverse event resulted in: death
Drug(s) suspected as cause:
Novoseven
Other drugs received by patient: Vasopressin; Aminocaproic Acid; Epsilon
Possible Novoseven side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-01
Patient: male
Reactions: Post Procedural Haemorrhage
Drug(s) suspected as cause:
Feiba
Novoseven
Feiba
Possible Novoseven side effects in
Reported by a physician from United States on 2012-04-26
Patient:
Reactions: Post Procedural Haemorrhage
Drug(s) suspected as cause:
Feiba
Novoseven
Possible Novoseven side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-26
Patient: 46 year old male
Reactions: Deep Vein Thrombosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Novoseven
Dosage: 4 mg, qid
Start date: 2011-09-04
End date: 2011-09-04
Novoseven
Dosage: 5 mg, tid
Start date: 2011-08-31
End date: 2011-08-31
Novoseven
Dosage: 5 mg, qid
Start date: 2011-09-02
End date: 2011-09-02
Novoseven
Dosage: 2 mg, tid
Start date: 2011-08-30
End date: 2011-08-30
Novoseven
Dosage: 5 mg qd then 4 mg tid
Start date: 2011-09-03
End date: 2011-09-03
Novoseven
Dosage: 4 mg qid and 5 mg qd
Start date: 2011-09-05
End date: 2011-09-05
Novoseven
Dosage: 5 mg,qd
Indication: Shock Haemorrhagic
Start date: 2011-08-29
End date: 2011-08-29
Novoseven
Dosage: 5 mg, tid
Start date: 2011-09-01
End date: 2011-09-01
Novoseven
Dosage: 5 mg, qid
Start date: 2011-09-06
End date: 2011-09-06
Other drugs received by patient: Omeprazole
Possible Novoseven side effects in 48 year old male
Reported by a physician from Italy on 2012-04-26
Patient: 48 year old male, weighing 150.0 kg (330.0 pounds)
Reactions: Troponin I Increased
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 68 year old male
Reported by a physician from Italy on 2012-04-19
Patient: 68 year old male, weighing 100.0 kg (220.0 pounds)
Reactions: Cerebral Infarction, Troponin I Increased, Deep Vein Thrombosis
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 74 year old female
Reported by a physician from Italy on 2012-04-19
Patient: 74 year old female
Reactions: Troponin I Increased, Deep Vein Thrombosis
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-16
Patient: 54 year old male
Reactions: Atrioventricular Block Complete, Myocardial Ischaemia, Bradycardia, Cardiogenic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Novoseven
Other drugs received by patient: Dobutamine HCL
Possible Novoseven side effects in 64 year old male
Reported by a physician from Israel on 2012-04-16
Patient: 64 year old male
Reactions: Multi-Organ Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-05
Patient: 46 year old male
Reactions: Deep Vein Thrombosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Novoseven
Other drugs received by patient: Omeprazole
Possible Novoseven side effects in male
Reported by a physician from Germany on 2012-04-04
Patient: male
Reactions: Renal Haemorrhage, Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
Possible Novoseven side effects in 90 year old female
Reported by a physician from Japan on 2012-04-02
Patient: 90 year old female, weighing 43.0 kg (94.6 pounds)
Reactions: Death, Drug Ineffective
Adverse event resulted in: death
Drug(s) suspected as cause:
Novoseven
Other drugs received by patient: Fresh Frozen Plasma
Possible Novoseven side effects in 30 year old female
Reported by a physician from France on 2012-03-22
Patient: 30 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: Overdose, Maternal Exposure During Pregnancy, Pulmonary Embolism, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novoseven
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