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)

Butalbital ballicule — decagon mechanism diagram — Butalbital

Acetaminophen ballicule — decagon mechanism diagram — Acetaminophen

Caffeine ballicule — decagon mechanism diagram — Caffeine

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

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability2 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Defining liabilityBarbiturate dependence, respiratory depression and hepatic injury

Part D rank #386.

Self-check

Which component carries the combination’s boxed hepatotoxicity risk?
Acetaminophen.
What headache indication is listed for butalbital/acetaminophen/caffeine?
Tension headache.

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