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.

This drug should be used by pregnant women only if clearly needed.

US FDA pregnancy category: C

Comments: It is unknown whether this drug can cause fetal harm or can affect reproduction capacity. Animal reproduction studies have not been conducted.

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The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-The average caffeine levels in the milk of 5 postpartum women given a 150 mg oral dose of this drug were 1.6, 1.5, and 0.9 mg/L at 30, 60, and 120 minutes after the dose, respectively.
-The milk caffeine levels of one woman who also received a 300 mg dose were about double those after her 150 mg dose.

-Fussiness, jitteriness, and poor sleep patterns have been reported in infants of mothers with caffeine intakes equivalent to about 10 or more cups of coffee daily.
-No stimulatory effects were observed in infants 3 weeks of age and older of mothers who drank 5 cups of coffee daily.
-Caffeine clearance is very low in preterm and newborn infants, but reaches adult levels by 3 to 5 months of age.

See references