FIORICET
Combination product
Pronunciation: byoo-TAL-bi-tal and a-set-a-MEE-noe-fen and KAF-een
Combination of Butalbital, Acetaminophen and Caffeine.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Components (3)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Hepatotoxicity — acetaminophen associated with acute liver failure, transplant, and death, usually at doses >4000 mg/day or with multiple acetaminophen-containing products.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Tension (muscle contraction) headache | Adults | 1–2 tablets q4h PRN | 1–2 tablets q4h PRN | 6 tablets/day |
Renal Prescribe with caution in severe renal impairment; monitor with serial renal function tests
Hepatic Prescribe with caution in severe hepatic impairment; monitor with serial liver function tests (acetaminophen hepatotoxicity risk)
Total daily dosage should not exceed 6 tablets
Instructions
- Do not exceed 4000 mg acetaminophen per day
- Do not exceed 6 tablets per day
- Extended/repeated use not recommended (butalbital is habit-forming)
- Avoid alcohol and other CNS depressants
Available strengths
- tab 50/325/40 mg
- cap 50/300/40, 50/325/40 mg
- sol 50/325/40 mg/15 mL
Contraindications
- Porphyria
Cautions
- Hepatotoxicity (acetaminophen)
- Serious skin reactions (AGEP, SJS, TEN)
- Hypersensitivity/anaphylaxis
- Habit-forming/potential for abuse (butalbital)
- Additive CNS depression with alcohol/CNS depressants
Adverse reactions
- Drowsiness
- Lightheadedness
- Dizziness
- Sedation
- Nausea/vomiting
- Abdominal pain
- Intoxicated feeling
Pregnancy Pregnancy Category C; no adequate studies; neonatal withdrawal seizures reported after maternal butalbital use late in pregnancy.
Lactation Undefined
Cost
FIORICET
What pharmacies pay · NADAC 9/30/26
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 50/325/40 mg | tab | per unit | $0.12/ea | not offered |
Part D rank #385.