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Phytonadione (Phytonadione) - Side Effect Reports to FDA

 
 



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 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 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 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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