Acetaminophen, butalbital, and caffeine 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.
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 (acetaminophen); Yes (barbiturates); Yes (caffeine)
Effects in Breastfed Infants
The mother of a newborn took a product containing acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg every 6 hours for 24 hours for a spinal headache, with the last dose a day prior to presentation at the emergency department. Her 7-day-old infant had a history of 1 to 2 days of poor feeding, lethargy and vomiting. The infant was somnolent, lethargic, and demonstrating diminished reflexes. The urine was qualitatively positive for barbiturate and had also had 1 mg/L of caffeine 15 hours after hospital admission. The infant’s symptoms resolved within 24 hours. The symptoms were probably caused by butalbital.
If you are PREGNANT
- No Known Fetal/Neonatal Risk:
- FDA C (unknown human fetal risk; assess risk/benefit):
- FDA C (unknown human fetal risk; assess risk/benefit):
If you are NURSING
- Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
- Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
- No Known Risk: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT
If you are an adult over 60
- management or monitoring precaution: General-Not recommended in the elderly due to sedation which may predispose to falls. May exacerbate depression. Renal-Renal excretion may increase adverse events with renal impairment. Monitor renal function.
- management or monitoring precaution: Hepatic-Elderly may be more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose is recommended, and the maximum dose recommendation varies between 3000-3800 mg depending on strength used and source of the recommendation.
Giving Fioricet to a child under 12
- management or monitoring precaution: Use weight based dosing in children less than 12 years.
- management or monitoring precaution: Adverse CNS effects (e.g. insomnia, restlessness, nervousness, and mild delirium) may be more severe in children.
- Severe Precaution: Safety and effectiveness not established age < 12 years.
- management or monitoring precaution: Caution in infants with seizure disorder, cardiovascular disease, renal impairment, or hepatic impairment.