This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Phytonadione 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 (7)
Reports by Reaction Type
Deep Vein Thrombosis (3),
Needle Issue (2),
Haemorrhage (1),
Injection Site Haematoma (1),
Injection Site Haemorrhage (1),
Anaphylactic Reaction (1),
Hepatic Failure (1),
Renal Impairment (1)
Possible Phytonadione side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14
Patient: , weighing 2.1 kg (4.6 pounds)
Reactions: Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Phytonadione
Dosage: injection
Indication: Vitamin K Deficiency
Start date: 2012-04-24
Phytonadione
Dosage: injection
Indication: Prophylaxis
Start date: 2012-04-24
Possible Phytonadione side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-21
Patient: male
Reactions: Needle Issue
Drug(s) suspected as cause:
Phytonadione
Other drugs received by patient: Erythromycin
Possible Phytonadione side effects in 60 year old male
Reported by a pharmacist from United States on 2012-02-15
Patient: 60 year old male, weighing 77.6 kg (170.7 pounds)
Reactions: Deep Vein Thrombosis
Drug(s) suspected as cause:
Factor VIIA
Dosage: 1 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2011-05-27
End date: 2011-05-27
Factor VIIA
Dosage: 1 mg; total; iv
Indication: Extradural Haematoma
Start date: 2011-05-27
End date: 2011-05-27
Phytonadione
Dosage: 5 mg; total; iv
Indication: Extradural Haematoma
Start date: 2011-05-27
End date: 2011-05-27
Phytonadione
Dosage: 5 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2011-05-27
End date: 2011-05-27
Profilnine SD
Dosage: 3530 iu; total; iv
Indication: International Normalised Ratio Increased
Start date: 2011-05-27
End date: 2011-05-27
Profilnine SD
Dosage: 3530 iu; total; iv
Indication: Extradural Haematoma
Start date: 2011-05-27
End date: 2011-05-27
Other drugs received by patient: Warfarin Sodium
Possible Phytonadione side effects in 62 year old male
Reported by a pharmacist from United States on 2012-02-15
Patient: 62 year old male, weighing 66.0 kg (145.2 pounds)
Reactions: Deep Vein Thrombosis
Drug(s) suspected as cause:
Factor VIIA
Dosage: 1 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-10-24
End date: 2010-10-24
Factor VIIA
Dosage: 1 mg; total; iv
Indication: Subdural Haematoma
Start date: 2010-10-24
End date: 2010-10-24
Phytonadione
Dosage: 5 mg; total; iv
Indication: Subdural Haematoma
Start date: 2010-10-25
End date: 2010-10-25
Phytonadione
Dosage: 5 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-10-25
End date: 2010-10-25
Profilnine SD
Dosage: 2250 iu; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-10-24
End date: 2010-10-24
Profilnine SD
Dosage: 2250 iu; total; iv
Indication: Subdural Haematoma
Start date: 2010-10-24
End date: 2010-10-24
Other drugs received by patient: Warfarin Sodium
Possible Phytonadione side effects in 85 year old male
Reported by a pharmacist from United States on 2012-02-15
Patient: 85 year old male, weighing 65.9 kg (145.0 pounds)
Reactions: Deep Vein Thrombosis
Drug(s) suspected as cause:
Factor VIIA
Dosage: 1 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-06-16
End date: 2010-06-16
Factor VIIA
Dosage: 1 mg; total; iv
Indication: Haemorrhagic Stroke
Start date: 2010-06-16
End date: 2010-06-16
Phytonadione
Dosage: 10 mg; total; iv
Indication: Haemorrhagic Stroke
Start date: 2010-06-16
End date: 2010-06-16
Phytonadione
Dosage: 10 mg; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-06-16
End date: 2010-06-16
Profilnine SD
Dosage: 2500 iu; total; iv
Indication: International Normalised Ratio Increased
Start date: 2010-06-16
End date: 2010-06-16
Profilnine SD
Dosage: 2500 iu; total; iv
Indication: Haemorrhagic Stroke
Start date: 2010-06-16
End date: 2010-06-16
Possible Phytonadione side effects in female
Reported by a pharmacist from United States on 2011-12-30
Patient: female, weighing 2.6 kg (5.7 pounds)
Reactions: Injection Site Haemorrhage, Injection Site Haematoma, Needle Issue
Drug(s) suspected as cause:
Phytonadione
Possible Phytonadione side effects in 79 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-29
Patient: 79 year old male, weighing 73.6 kg (161.9 pounds)
Reactions: Renal Impairment, Anaphylactic Reaction, Hepatic Failure
Drug(s) suspected as cause:
Phytonadione
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