NDAORALCAPSULE
Approved
Jul 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
FIORICET W/ CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) by Teva is butalbital, a barbiturate, is a gaba a receptor agonist and may inhibit excitatory ampa receptors. Approved for the symptom complex of tension (or muscle contraction) headache, alternative treatments are inadequate, other non-opioid analgesic. First approved in 1992.
Drug data last refreshed 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fioricet with Codeine is a fixed-dose oral capsule combining butalbital (barbiturate), acetaminophen, caffeine, and codeine phosphate (opioid) for tension headache management. Butalbital acts as a GABA-A receptor agonist and CNS depressant, acetaminophen provides analgesic effects through central mechanisms, caffeine acts as a CNS stimulant via adenosine receptor antagonism, and codeine provides opioid analgesia primarily through mu-receptor agonism and conversion to morphine. It is indicated for tension headaches when alternative non-opioid treatments are inadequate.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand teams should focus on managed decline and generic transition strategies.
Mechanism of Action
Butalbital, a barbiturate, is a GABA A receptor agonist and may inhibit excitatory AMPA receptors. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Caffeine is a methylxanthine and CNS stimulant. The exact mechanism…
Pharmacologic Class:
Barbiturate
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.