Butalbital: uses, side effects and safety
Butalbital (Fioricet) is a barbiturate (butalbital) combination analgesic. It is a US Schedule III controlled substance. It is prescription only (rx) and remains on the US market.
What is Butalbital?
Butalbital is the generic name for Fioricet, and belongs to the Barbiturate (butalbital) combination analgesic class.
| Generic name | butalbital, acetaminophen, and caffeine |
|---|---|
| Brand name(s) | Fioricet |
| Drug class | Barbiturate (butalbital) combination analgesic |
| US legal status | US Schedule III ยท Prescription only (Rx) |
| Route | Oral |
| Prescription required | Yes |
| Elimination half-life | Butalbital plasma half-life about 35 hours; acetaminophen plasma half-life 1.25 to 3 hours; caffeine plasma half-life about 3 hours |
| Metabolism | Butalbital elimination is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites; acetaminophen elimination is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites; caffeine is cleared through hepatic metabolism and excretion in the urine |
What is Butalbital used for?
Butalbital is approved by the FDA for the following uses. Approval is granted per indication, and a specific product may not be approved for all of them.
- Relief of the symptom complex of tension (or muscle contraction) headache
Common side effects of Butalbital
These are the side effects people report most often. Many diminish after the body adjusts, usually within one to two weeks.
- Drowsiness
- Lightheadedness
- Dizziness
- Sedation
- Shortness of breath
- Nausea
- Vomiting
- Abdominal pain
- Intoxicated feeling
What does Butalbital interact with?
Interactions matter because two safe medicines can become dangerous together. The entries below are the ones most likely to cause harm.
- Alcohol and other CNS depressants: additive sedation and impairment of mental and/or physical performance
- Acetaminophen-containing products: total acetaminophen dose must be accounted for to avoid hepatotoxicity
- Other hepatotoxic drugs
- Concomitant use with drugs that impair mental and/or physical abilities required for hazardous tasks
Use our drug interaction checker before combining any two prescriptions.
Serious side effects and warning signs
Seek emergency care for any of these
- Boxed warning: acetaminophen overdose can cause serious liver damage, which can lead to acute liver failure and death
- Seizure
- Toxic epidermal necrolysis and erythema multiforme (postmarketing)
- Hepatic failure with overdose
- Allergic reactions
- Mental confusion, excitement, or depression due to intolerance, particularly in elderly or debilitated patients
Suspected overdose or a bad reaction should be reported to Poison Control on 1-800-222-1222. That is staffed around the clock and is free.
Legal status of Butalbital
Butalbital is a Schedule III controlled substance in the United States. That placement is set out in Title 21 of the Code of Federal Regulations, Part 1308, and enforced by the Drug Enforcement Administration. It carries restrictions on prescribing, storage, record-keeping and transfer.
Statutory reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a68de112-f5af-49ba-a8a8-3adbaa7df36e.
Can you get Butalbital without a prescription?
Short answer: no. Butalbital is a prescription medication. Sites advertising it without one are either operating illegally or selling something other than what they claim. We explain the legal routes, the counterfeit problem and how to check a source in detail.
Read the full answer: Butalbital without a prescription →
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Read more →Frequently asked questions
What is Butalbital used for?
Relief of the symptom complex of tension (or muscle contraction) headache
What schedule is Butalbital in the United States?
Butalbital is a Schedule III controlled substance in the US, listed at 21 CFR Part 1308. Schedule III means the drug has a defined potential for abuse and is subject to federal record-keeping, storage and prescribing restrictions.
What are the common side effects of Butalbital?
The most frequently reported side effects are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea. Many lessen over the first week or two of treatment.
What should not be combined with Butalbital?
The most clinically important interactions are with alcohol and other cns depressants: additive sedation and impairment of mental and/or physical performance, acetaminophen-containing products: total acetaminophen dose must be accounted for to avoid hepatotoxicity, other hepatotoxic drugs, concomitant use with drugs that impair mental and/or physical abilities required for hazardous tasks. Always give a pharmacist or prescriber a complete list of everything you take, including over-the-counter drugs and supplements.
Sources & references
Important
This site provides educational information only and does not sell, prescribe or dispense medications. Always consult a licensed healthcare provider. This page is not medical advice.