Vitamin K1 (Phytonadione) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Deaths have occurred after intravenous and intramuscular administration. (See Box Warning.)

Transient “flushing sensations” and “peculiar” sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

Pain, swelling, and tenderness at the injection site may occur.

The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind.

Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans.

Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended. (See PRECAUTIONS, Pediatric Use.)

REPORTS OF SUSPECTED VITAMIN K1 SIDE EFFECTS / ADVERSE REACTIONS

Possible Vitamin K1 side effects / adverse reactions in 56 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-07

Patient: 56 year old male

Reactions: Anaphylactoid Shock

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Acupan
    Dosage: 4 df total daily (1df, 1 in 6 hours)

Piperacillin and Tazobactam
    Dosage: 12 g total daily (4 g, 1 in 8 hours)
    Indication: Lung Infection
    Start date: 2011-09-08

Primperan TAB
    Dosage: 3 df total daily (1 df (10 mg/2 ml), 1 in 8 hours)

Vitamin K1
    Dosage: 10 mg, 1x/day

Proglycem
    Dosage: unk; increased dose
    Start date: 2010-09-01

Vancomycin
    Dosage: 2 g, 1x/day
    Start date: 2011-09-08

Ciprofloxacin
    Dosage: 800 mg total daily (400 mg, 1 in 12 hours)
    Indication: Lung Infection
    Start date: 2011-09-08

Proglycem
    Dosage: 200 mg, 4x/day
    Administration route: Oral
    Indication: Hypoglycaemia
    Start date: 2011-02-01
    End date: 2011-09-01

Other drugs received by patient: Lovenox

Possible Vitamin K1 side effects / adverse reactions in 34 year old female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 34 year old female weighing 176.9 kg (389.2 pounds)

Reactions: Rash Pustular, Contusion, Rash Erythematous, Injection Site Rash

Suspect drug(s):
Vitamin K1
    Dosage: 1 shot
    Indication: International Normalised Ratio Increased
    Start date: 2011-11-29
    End date: 2011-11-29

Vitamin K1
    Dosage: 1 shot
    Indication: Blood Thromboplastin Increased
    Start date: 2011-11-29
    End date: 2011-11-29