Acetaminophen / butalbital Pregnancy and Breastfeeding Warnings
Brand names: Allzital, Axocet, Bucet, Bupap, Butex Forte, Cephadyn, Dolgic, Marten-Tab, Orbivan CF, Phrenilin, Phrenilin Forte (old formulation), Promacet, Prominol, Sedapap, Tencon, Triaprin
Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.
Acetaminophen / butalbital Pregnancy Warnings
Use is not recommended unless clearly needed.
US FDA pregnancy category: C
Comment: Monitor for barbiturate withdrawal in neonates
Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. There are no controlled studies with this combination product in pregnant patients.
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.
Acetaminophen / butalbital Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes (barbiturates); Yes (acetaminophen)
Both acetaminophen and butalbital are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.
See also
References for pregnancy information
- U.S. Food and Drug Administration U.S. Food and Drug Administration U.S. Food and Drug Administration U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm 2015.
- Product Information. Allzital (acetaminophen-butalbital). Skylar Laboratories. 2016.
References for breastfeeding information
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- Product Information. Allzital (acetaminophen-butalbital). Skylar Laboratories. 2016.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
