Drug Levels and Effects
Summary of Use during Lactation
Bitter orange (Citrus aurantium) fruit contains several adrenergic agonists, primarily p-synephrine, but also octopamine and tyramine, as well as numerous flavonoids. Bitter orange has no specific lactation-related uses, but high dosages are often used in weight-loss agents. No data exist on the excretion of any components of bitter orange into breastmilk or on the safety and efficacy of bitter orange in nursing mothers or infants. Bitter orange is "generally recognized as safe" (GRAS) as a food and flavoring by the U.S. Food and Drug Administration. High dosages of bitter orange are often combined with caffeine and other stimulants in weight loss products, and the combinations may cause cardiac stimulation. Because of the lack of information on high dosages used in supplements and because animal data indicate that the adrenergic agents in bitter orange might decrease milk production, it should probably be avoided by nursing mothers, especially while nursing a newborn or preterm infant.
Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.
Drug Levels
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information in humans was not found as of the revision date. However, animal data indicate that octopamine decreases prolactin and might decrease milk production.[1] Pseudoephedrine, a pharmacologically similar vasoconstrictor, decreases milk production in nursing mothers after oral use.[2]
References
- 1.
- Becú-Villalobos D, Thyssen SM, Rey EB, et al. Octopamine and phenylethylamine inhibit prolactin secretion both in vivo and in vitro. Proc Soc Exp Biol Med. 1992;199:230–5. [PubMed: 1741415]
- 2.
- Aljazaf K, Hale TW, Ilett KF, et al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003;56:18–24. [PMC free article: PMC1884328] [PubMed: 12848771]
Substance Identification
Substance Name
Bitter Orange
Scientific Name
Citrus aurantium
Drug Class
Breast Feeding
Lactation
Complementary Therapies
Food
Phytotherapy
Plants, Medicinal
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
Publication Details
Publication History
Last Revision: June 21, 2021.
Copyright
Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Publisher
National Institute of Child Health and Human Development, Bethesda (MD)
NLM Citation
Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Bitter Orange. [Updated 2021 Jun 21].