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.

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Caffeine appears in breastmilk rapidly after maternal ingestion as it readily crosses the placenta into the fetal circulation. 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 per day). Studies in mothers taking 5 cups of coffee per day found no stimulatory effects in infants 3 weeks of age or older. Preterm and younger newborn infants metabolize caffeine very slowly and therefore a lower maternal intake is preferable. Coffee intake of more than 450 mL daily may decrease breastmilk iron concentrations and result in mild iron deficiency anemia in some breastfed infants.

Caution is recommended

Excreted into human milk: Yes

Comments:
-Breastfeeding mothers of infants receiving caffeine citrate should not ingest caffeine-containing foods, beverages, and medicinal products; preterm infants metabolize caffeine very slowly.
-There is insufficient high-quality data to make good evidence-based recommendations on safe maternal caffeine consumption; however, a maternal intake limit of 300 to 500 mg daily appears well tolerated in most infants 3 weeks of age or older.

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