Norepinephrine Pregnancy and Breastfeeding Warnings
Brand names: Levophed, Levophed Bitartrate
Medically reviewed by Drugs.com. Last updated on Apr 25, 2025.
Norepinephrine Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk summary: Limited data available on the use of this drug in pregnant women to inform a drug-related risk.
Animal studies indicate the potential for placental perfusion and induction of fetal bradycardia. This drug may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Norepinephrine Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
Animal studies suggest this drug can decrease serum prolactin and reduce milk production, as well as inhibit the release of oxytocin which inhibits milk ejection. High IV doses may reduce milk production or milk letdown.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2017) "Product Information. Levophed (norepinephrine)." Hospira Inc
- (2020) "Product Information. Levophed (norepinephrine)." Hospira Inc
- (2024) "Product Information. Norepinephrine Bitartrate (norepinephrine)." Hikma USA (formerly West-Ward Pharmaceutical Corporation)
- (2022) "Product Information. Norepinephrine Bitartrate (norepinephrine)." Fresenius Kabi USA, LLC
- (2023) "Product Information. Norepinephrine Bitartrate (norepinephrine)." Baxter Healthcare Corporation
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- (2017) "Product Information. Levophed (norepinephrine)." Hospira Inc
Further information
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