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Phytonadione Pregnancy and Breastfeeding Warnings

Brand names: Aquamephyton, Konakion, Mephyton, Vitamin K, Vitamin K1

Medically reviewed by Drugs.com. Last updated on Jul 25, 2025.

Phytonadione Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: Not assigned
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Certain formulations of this drug contain benzyl alcohol.
-Preservative-free formulations are recommended if this drug is needed during pregnancy.

Animal studies have not been reported. There are no controlled data in human pregnancy; however, the administration of vitamin K1 to pregnant women shortly before delivery showed an increase in both maternal and cord blood concentrations.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Phytonadione Breastfeeding Warnings

Caution is recommended; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comments:
-Certain formulations of this drug contain benzyl alcohol. Preservative-free formulations are recommended if this drug is needed during lactation.
-Not recommended for nursing mothers as prophylaxis of newborn hemorrhagic disease.

The American Academy of Pediatrics classifies vitamin K1 as compatible with breastfeeding; they also caution that administration to the mother prenatally should not be substituted for newborn prophylaxis.

See references

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See also

References for pregnancy information

  1. (2022) "Product Information. Vitamin K (phytonadione)." Apothecon Inc
  2. (2001) "Product Information. Mephyton (phytonadione)." Merck & Co., Inc
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2022) "Product Information. Vitamin K (phytonadione)." Apothecon Inc
  2. (2001) "Product Information. Mephyton (phytonadione)." Merck & Co., Inc
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. Briggs GG, Yaffe SJ., Freeman RK (2011) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Llippincott Williams & Wilkins

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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