Skip to Content

Theophylline Pregnancy and Breastfeeding Warnings

Theophylline is also known as: Aerolate III, Aerolate JR, Aerolate SR, Bronkodyl, Constant-T, Elixophyllin, Quibron-T/SR, Respbid, Slo-Bid Gyrocaps, Slo-Phyllin, Slo-Phyllin 125, T-Phyl, Theo-24, Theo-Dur, Theo-Dur Sprinkles, Theo-Time, Theo-X, Theobid, Theoclear LA-130, Theoclear LA-260, Theolair, Theolair-SR, Theovent, Uni-Dur, Uniphyl

Medically reviewed on Nov 13, 2018

Theophylline Pregnancy Warnings

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

Theophylline Breastfeeding Warnings

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

References for pregnancy information

  1. "Product Information. Theophylline ER (theophylline)." Mylan Pharmaceuticals Inc, Morgantown, WV.
  2. "Product Information. Theophylline (theophylline)." B. Braun Medical, Irvine, CA.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

References for breastfeeding information

  1. "Product Information. Theophylline (theophylline)." B. Braun Medical, Irvine, CA.
  2. "Product Information. Theophylline ER (theophylline)." Mylan Pharmaceuticals Inc, Morgantown, WV.
  3. "Product Information. Elixophyllin (theophylline)." Nostrum Laboratories Inc, Kansas City , MO.

Further information

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

Hide