Applies to phytonadione: oral capsule, oral tablet. Other dosage forms:

• injection emulsion, injection solution

Serious side effects of Phytonadione

Along with its needed effects, phytonadione may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking phytonadione:

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chest tightness
• confusion
• cough
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid and weak pulse
• sweating
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Other side effects of Phytonadione

Some side effects of phytonadione may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Change in taste
• feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest

For Healthcare Professionals

Applies to phytonadione: compounding powder, injectable solution, oral tablet.

Local

Rare (less than 0.1%): Injection site reactions (inflammation, atrophy, necrosis)

Very rare (less than 0.01%): Venous irritation or phlebitis (IV route)

Frequency not reported: Pain, swelling, and tenderness at the injection site^[Ref]

Cardiovascular

Rare (less than 0.1%): Rapid and weak pulse, hypotension, cyanosis

Very rare (less than 0.01%): Facial flushing

Postmarketing reports: Tachycardia, flushing^[Ref]

Hypersensitivity

Fatalities and other severe reactions have occurred during or immediately after the parenteral administration of phytonadione. The majority of these reactions have occurred with intravenous administration. These reactions resemble hypersensitivity or anaphylaxis and include shock and cardiac or respiratory arrest. Feelings of uneasiness, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea may precede the cardiopulmonary event. These severe reactions are more likely with, but are not limited to, rapid infusions of undiluted drug.^[Ref]

Very rare (less than 0.01%): Anaphylactoid reactions (IV route)

Frequency not reported: Allergic sensitivity, anaphylaxis

Postmarketing reports: Fatal hypersensitivity reaction^[Ref]

Gastrointestinal

Gastrointestinal side effects have rarely included 'peculiar' sensations of taste.

Respiratory

Rare (less than 0.1%): Dyspnea^[Ref]

Other

Frequency not reported: Death (IV and IM routes)^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythematous, indurated, pruritic plaques

Rare (less than 0.1%): Profuse sweating, scleroderma-like lesions,

Very rare (less than 0.01%): Sweating

Frequency not reported: Erythema perstans-like lesions^[Ref]

Nervous system

Rare (less than 0.1%): Dizziness

Very rare (less than 0.01%): Unusual taste

Postmarketing reports: Dysgeusia^[Ref]

Hepatic

Hyperbilirubinemia occurred primarily with doses above those recommended.^[Ref]

Rare (less than 0.1%): Hyperbilirubinemia

Frequency not reported: Jaundice in newborns^[Ref]

Hematologic

Frequency not reported: Hemolysis in newborns^[Ref]

General

The most common adverse events were dermatologic and injection site reactions.^[Ref]