Skip to main content

Butalbital Pregnancy and Breastfeeding Warnings

Butalbital Pregnancy Warnings

Butalbital has been assigned to pregnancy category C by the FDA. Barbiturates in general have been reported to readily cross the placental barrier. Withdrawal seizures have been reported in a two day old infant whose mother had taken a butalbital containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. Animal reproduction studies have not been conducted. There are no controlled data in human pregnancy. Butalbital should be used during pregnancy only if the potential benefit justifies the potential risk to the infant.

See references

Butalbital Breastfeeding Warnings

Barbiturates are excreted in breast milk in small amounts. The significance of the effects on nursing infants has not been reported. Because of the potential for serious adverse reactions in nursing infants from butalbital, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Product Information. Fioricet (acetaminophen/butalbital/caffeine). Novartis Pharmaceuticals. 2022.
  2. Product Information. Fioricet with Codeine (acetaminophen/butalbital/caffeine/codeine). Novartis Pharmaceuticals. 2022.
  3. Product Information. Fiorinal with Codeine (aspirin/butalbital/caffeine/codeine). Novartis Pharmaceuticals. 2022.
  4. Product Information. Fiorinal (aspirin/butalbital/caffeine). Actavis (formerly Abrika Pharmaceuticals LLP). 2022.
  5. Product Information. Sedapap (acetaminophen-butalbital). Merz Pharmaceuticals. 2001;PROD.
  6. Product Information. Esgic-Plus (acetaminophen/butalbital/caffeine). Forest Pharmaceuticals. 2022.

References for breastfeeding information

  1. Product Information. Fioricet (acetaminophen/butalbital/caffeine). Novartis Pharmaceuticals. 2022.
  2. Product Information. Fioricet with Codeine (acetaminophen/butalbital/caffeine/codeine). Novartis Pharmaceuticals. 2022.
  3. Product Information. Fiorinal with Codeine (aspirin/butalbital/caffeine/codeine). Novartis Pharmaceuticals. 2022.
  4. Product Information. Fiorinal (aspirin/butalbital/caffeine). Actavis (formerly Abrika Pharmaceuticals LLP). 2022.
  5. Product Information. Sedapap (acetaminophen-butalbital). Merz Pharmaceuticals. 2001;PROD.
  6. Product Information. Esgic-Plus (acetaminophen/butalbital/caffeine). Forest Pharmaceuticals. 2022.

Further information

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