Short answer: Butalbital is a barbiturate sedative sold only in combinations, such as Fioricet (with acetaminophen and caffeine) and Fiorinal (with aspirin and caffeine), for tension headaches. Fiorinal is Schedule III; most acetaminophen versions are exempt from federal scheduling. Frequent use causes rebound headaches and dependence, and stopping suddenly can cause seizures.
Key takeaways
- What it is: Butalbital is a short-to-intermediate-acting barbiturate (in combinations) and a Schedule III controlled substance in the US.
- Main uses: Tension-type headache.
- Timing: effects start in 30 to 60 minutes and last 4 to 6 hours.
- Most dangerous mix: Opioids, which can cause profound sedation and slowed breathing.
- Naloxone: it does not reverse this drug, but give it whenever opioids could be involved.
- Dependence risk: Moderate to high.
- Legal route: only with a prescription from a DEA-registered clinician, filled by a licensed pharmacy.
What is butalbital?
Butalbital combinations relieve tension-type headache. Butalbital relaxes muscles and causes sedation; the other ingredients relieve pain.
The American Headache Society advises against butalbital for migraine and limits its use because of rebound headaches, dependence, and withdrawal risks. Most countries do not sell it.
Quick facts
| Fact | Butalbital |
|---|---|
| Generic name | Butalbital (with acetaminophen, aspirin, caffeine, or codeine) |
| Brand names | Fioricet, Esgic, Fiorinal, Fioricet with Codeine |
| Drug class | Barbiturate |
| US legal status | Fiorinal and codeine combinations: Schedule III; most butalbital, acetaminophen, and caffeine products: exempt, though some states control them |
| Approved uses | Tension-type headache |
| Forms | Capsules, tablets |
| Onset | 30 to 60 minutes |
| Half-life | About 35 hours |
How long does butalbital last?
- Starts working: 30 to 60 minutes
- Effects last: 4 to 6 hours
- Half-life: About 35 hours
Timing varies with the dose, the form, how it is taken, liver and kidney function, age, and other drugs taken at the same time.
What are the biggest risks of butalbital?
The FDA requires boxed warnings, its strongest, on butalbital products, including:
- Acetaminophen-containing products: liver failure, sometimes requiring transplant or causing death, from doses above 4,000 mg of acetaminophen a day.
- Codeine-containing products carry the opioid boxed warnings, including addiction, slowed breathing, and danger with benzodiazepines.
Common side effects include drowsiness, dizziness, lightheadedness, and nausea.
Medication overuse headache: taking butalbital on more than a few days a month makes headaches more frequent.
Dependence: regular use leads to barbiturate dependence; daily high doses can cause life-threatening withdrawal.
What should you never mix with butalbital?
| Combined with | What happens | Label guidance |
|---|---|---|
| Opioids | Profound sedation and slowed breathing | Avoid |
| Alcohol | Deep sedation; liver damage with acetaminophen products | Avoid |
| Benzodiazepines and other sedatives | Additive sedation | Avoid |
| Hormonal birth control, warfarin, and other drugs | Barbiturates speed their breakdown and reduce effect | Check with a pharmacist |
| Other acetaminophen products | Liver toxicity | Count total acetaminophen |
Check any combination with the DoseUses combination checker or ask a pharmacist.
What are the signs of a butalbital overdose, and what should you do?
Overdose causes drowsiness, confusion, slowed breathing, low blood pressure, and coma. Acetaminophen overdose may cause no early symptoms but can destroy the liver over 1 to 3 days, so seek care immediately.
If someone may have overdosed
- Call 911 if the person is unresponsive, hard to wake, or breathing slowly.
- For advice when the person is awake and stable, call Poison Help at 1-800-222-1222 (US, free, 24 hours).
- If opioids could be involved, including pills not from a pharmacy, give naloxone if you have it. Naloxone does not reverse butalbital, but it will not harm the person.
- Stay with the person and place them on their side if they are drowsy or vomiting.
What is butalbital withdrawal like, and how long does it last?
People who take butalbital daily, especially at high doses, can become physically dependent. Barbiturate withdrawal can be dangerous.
- Day 1 to 2Symptoms beginAnxiety, rebound headache, tremor, weakness, nausea, and insomnia.
- Days 2 to 5Peak riskSeizures and delirium can occur after heavy use.
- 1 to 2 weeksResolvesSymptoms ease with a supervised taper.
See the withdrawal timelines and the full butalbital withdrawal guide.
Is butalbital legal?
In the United States, butalbital is a Schedule III controlled substance. The only legal way to get it is with a prescription from a clinician registered with the Drug Enforcement Administration (DEA), filled by a licensed pharmacy. Depending on state law, that can be a physician, nurse practitioner, or physician assistant.
- Refills: a Schedule III prescription can be refilled up to five times within six months of the date it was written. After that, a new prescription is needed.
- Telehealth: federal flexibilities let DEA-registered clinicians prescribe Schedule II to V medicines after a telemedicine visit, without a prior in-person exam, through December 31, 2026. A permanent DEA rule was under final review in late 2026. State rules can be stricter.
- Monitoring: prescribers and pharmacists in most states check a prescription drug monitoring program, a database of controlled-substance prescriptions, before prescribing or dispensing.
Outside the United States
| Country | Status |
|---|---|
| United Kingdom | Not licensed; barbiturates are Class B |
| International | Butalbital is in Schedule III of the 1971 Convention on Psychotropic Substances |
Frequently asked questions about butalbital
Is Fioricet a controlled substance?
Most Fioricet products are exempt from federal scheduling, but Fiorinal and codeine versions are Schedule III, and some states control all of them.
Is butalbital good for migraine?
No. Headache specialists advise against it for migraine; triptans and other treatments work better.
Can butalbital cause rebound headaches?
Yes. Frequent use is a common cause of medication overuse headache.
Is butalbital a barbiturate?
Yes. It is a short-to-intermediate acting barbiturate.
Can you stop butalbital suddenly?
Occasional users can, but people taking it daily should taper with a clinician because of seizure risk.
Sources
- Fioricet (butalbital, acetaminophen, and caffeine) prescription information, DailyMed, US National Library of Medicine.
- Controlled Substance Schedules, DEA Diversion Control Division.
- 21 CFR 1306.22, Refilling of prescriptions (Schedules III and IV), Electronic Code of Federal Regulations.
- Prescribing controlled substances via telehealth, US Department of Health and Human Services.
- BeSafeRx: Your Source for Online Pharmacy Information, US Food and Drug Administration.
- Safe Pharmacy, National Association of Boards of Pharmacy.
- One Pill Can Kill, US Drug Enforcement Administration.
- International drug control conventions, United Nations Office on Drugs and Crime.
This guide summarizes the sourced DoseUses Butalbital profile, written from FDA labels, DEA rules, and federal health agencies. It is educational and is not medical advice. Last updated October 5, 2026.
