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Caffeine Pregnancy and Breastfeeding Warnings

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Medically reviewed by Last updated on Jun 11, 2019.

Caffeine Pregnancy Warnings

Use in moderation is generally considered acceptable; moderate amounts of caffeine consumption during pregnancy have not demonstrated a measurable risk to the fetus.

AU TGA pregnancy category: A
US FDA pregnancy category: C

Although studies in adult animals have revealed caffeine citrate caused embryotoxicity and teratogenicity, decreased male reproductive performance, and spermatogenic cell degeneration, these effects are not relevant to the use of this drug in infants as caffeine citrate is not indicated for use in adult patients.

No evidence of a relationship between the use of caffeine and congenital defects was found by the Collaborative Perinatal Project (CPP), which monitored more than 50,282 mother-child pairs (5378 of whom had first trimester exposure to caffeine). Additionally, a follow-up analysis by the CPP on maternal use of caffeine-containing beverages did not support caffeine as a teratogen. Other reports also have found no association between the use of caffeine during pregnancy and congenital malformations.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Caffeine Breastfeeding Warnings

Caffeine appears in breastmilk rapidly after maternal ingestion as it readily crosses the placenta into the fetal circulation. Studies in mothers taking 5 cups of coffee daily found no stimulatory effects in infants 3 weeks of age and older; however, a lower intake level may be preferable in the mothers of preterm and younger newborn infants who metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers' levels. Coffee intake of more than 450 mL daily may increase breastmilk iron concentrations and result in mild iron deficiency anemia in some breastfed infants.

Caffeine use is generally considered acceptable; the American Academy of Pediatrics classifies usual amounts of caffeinated beverages as compatible with breastfeeding.

Excreted into human milk: Yes

-Caffeine citrate is not indicated for use in adult patients.
-Advise breastfeeding mothers of infants receiving caffeine citrate to not ingest caffeine-containing foods, beverages, and medicinal products.

-Fussiness, jitteriness, and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes (equivalent to about 10 or more cups of coffee daily).

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL:" ([1999]):
  2. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 9th ed." Philadelphia, PA: Llippincott Williams & Wilkins (2011):
  3. "Product Information. Cafcit (caffeine)" Roxane Laboratories Inc, Columbus, OH.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Cafcit (caffeine)" Roxane Laboratories Inc, Columbus, OH.
  3. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 9th ed." Philadelphia, PA: Llippincott Williams & Wilkins (2011):

Further information

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