The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned

Comments:
-Aminophylline pharmacokinetics may be altered by pregnancy; consider measuring serum theophylline concentrations more frequently.

Rodent studies did not show teratogenicity at doses up to 3 times the recommended human dose, but embryotoxicity without maternal toxicity was seen at 220 mg/kg. Animal studies in non-rodent species have not been performed. Theophylline passes freely across the placenta. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-Aminophylline is approximately 79% anhydrous theophylline by weight.
-Theophylline is excreted in breast milk and may cause irritability or other mild toxicities in nursing infants; serious toxicity is only expected at toxic serum concentrations.
-The concentration of theophylline is about the same in breast milk as in serum.

See references