Fiorinal

Barbiturate (butalbital), NSAID (aspirin), Methylxanthine (caffeine), Fixed-dose combination, Schedule III controlled substance

Butalbital / Aspirin / Caffeine

Fiorinal; with codeine as Fiorinal with Codeine (Schedule III)

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Summary

Classes

Barbiturate (butalbital), NSAID (aspirin), Methylxanthine (caffeine), Fixed-dose combination, Schedule III controlled substance

Common uses

Tension-type headache (limited evidence; falling out of favor due to medicine-overuse headache and barbiturate dependence risk)▲0▼

Pharmacy

Starting dose

1-2 capsules (50 mg butalbital / 325 mg aspirin / 40 mg caffeine each) PO every 4 hours as needed; maximum 6 capsules/d

Preparations

50/325/40 mg capsules

US FDA Max

6 capsules/d (300 mg butalbital, 1950 mg aspirin, 240 mg caffeine)

Pharmacology

Routes

Oral

Onset

30-60 minutes

Duration

4-6 hours

Half-life

Butalbital ~35 hours; aspirin (acetyl group) ~15 minutes, salicylate 2-3 hours; caffeine 3-7 hours

Bioavailability

Butalbital well-absorbed; aspirin 50-75%; caffeine ~100%

Pregnancy

Avoided; barbiturate + aspirin teratogenicity and bleeding concerns.^{[citation needed]}

Legal status

Schedule III controlled substance in US (Fiorinal is scheduled federally; Fioricet with acetaminophen is unscheduled federally despite identical butalbital content, a regulatory quirk)

Purported mechanism

Same as Fioricet but with aspirin substituted for acetaminophen as the non-opioid analgesic component. Butalbital positively modulates GABA-A; aspirin provides non-selective COX inhibition with anti-inflammatory effect; caffeine provides vasoconstriction and analgesic-absorption enhancement.▲0▼ Same concerns as Fioricet plus aspirin GI/bleeding risk; the only practical difference favoring Fiorinal is potential anti-inflammatory benefit in headaches with inflammatory component, though clinical guidance does not differentiate strongly between them.