Animal studies showed teratogenicity when administered during organogenesis; cleft palate and digital abnormalities were seen with a single intraperitoneal dose, approximately equal to the maximum recommended adult oral dose, given during organogenesis; at doses approximately twice the maximum recommended adult oral dose, micromelia, micrognathia, digital abnormalities, clubfoot, cleft palate, subcutaneous hematoma, open eyelids, and embryolethality occurred. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-This drug may cause irritability or other mild toxicities in nursing infants.
-The breastmilk theophylline concentration is about equal to the mother's serum concentration.
-Serious adverse effects are unlikely unless maternal serum concentrations are toxic.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-This drug may cause irritability or other mild toxicities in nursing infants.
-The breastmilk theophylline concentration is about equal to the mother's serum concentration.
-Serious adverse effects are unlikely unless maternal serum concentrations are toxic.

See references