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Fioricet (Acetaminophen, Butalbital, and Caffeine)
Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration.
Each capsule contains:
Butalbital ……………….. 50 mg
Warning: May be habit-forming.
Acetaminophen ………. 325 mg
Caffeine …………………. 40 mg
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate.Acetaminophen (4′-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic.Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant.
Fioricet is a barbiturate sedative mixed with a non-aspirin pain medication and caffeine. This non-narcotic pain medication and relaxant is often prescribed for tension headaches caused by contractions of the muscles in the neck and shoulder area, and migraine.
Why is this medication prescribed?
This combination of drugs is used to relieve tension headaches. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.
This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.
What special precautions should I follow?
Before taking acetaminophen, Butalbital, Caffeine,
- tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants (‘blood thinners’) such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
- tell your doctor if you have or have ever had liver disease, porphyria, or depression.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.
What special dietary instructions should I follow?
Acetaminophen, Butalbital, Caffeine may cause an upset stomach. Take this medicine with food or milk.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
An overdose of Fioricet, or combining this medication with alcohol or other central nervous system depressant, may lead to unconsciousness or perhaps death. Fioricet overdose is indicated by severe drowsiness, confusion, extreme weakness, hallucination, shortness of breath, too slow or troubled breathing, slurred speech, lack of coordination, vomiting with blood, unusually slow heartbeat.
The treatment of Fioricet overdose is complicated by the presence of two substances which are highly toxic when taken in excessive amounts. Fioricet overdoses generally result in toxic amounts of both acetaminophen and butalbital being consumed at once, requiring both overdoses to be treated at once. Fioricet overdose by anyone and/or any consumption by persons to whom it is not prescribed (particularly children) is always a medical emergency and medical attention must be sought immediately if an overdose or consumption by other persons is suspected. Fioricet overdose is often fatal and symptoms may not present for hours following consumption; once initial overdose symptoms present they can progress rapidly and there may not be time to reach appropriate medical care after this point.
Acetaminophen exerts its toxicity through the production of a toxic metabolite which can sometimes produce liver damage with doses as low as 4,000 mg, although normally requiring doses that are much higher. Acute liver failure may result in doses greatly exceeding this, and death has been known to occur with ingestion of 10,000-15,000 mg (10-15 grams of pure acetaminophen). The specific antidote to acetaminophen overdose is N-acetylcysteine. Acute renal failure and upper gastrointestinal bleeding may also occur.
Butalbital exerts its toxicity through excessive sedation resulting in respiratory depression and ultimately death via hypoxia. Nonlethal overdoses may also result in coma and death. There is no specific antidote to barbiturate overdose and treatment is supportive. Common treatment regimens generally include the administration of intravenous administration of saline, naloxone, thiamine, glucose, sodium bicarbonate to alkalize the urine to increase rate of excretion, and activated charcoal via nasogastric tube. It is not uncommon for a doctor to recommend observation of the patient in the emergency department for a number of hours or admission to the hospital for several days of observation if symptoms are severe and to counsel the patient on drug abuse or refer them for psychiatric evaluation.
Is Generic Fioricet the same as the Brand?
Generic drugs, including generic Fioricet and alternately branded versions of Fioricet are not exactly the same as the original branded drug, although they are very similar and are widely viewed to be as effective as their branded counterparts. To learn more about the difference between branded prescription medications and generics, visit the Generic versus brand name section of our drug basics section.
Is Fioricet available as a generic?
Yes. Several manufacturers produce generic versions of Fioricet. Additionally, ,medications with the same ingredients (sometimes at different strengths) as Fioricet have been available for many years from multiple manufacturers.
Currently available formulations of Fioricet (or other brands) include:
- Acetaminophen 300 mg /Butalbital 50mg /Caffeine 40 mg Capsule: Oral
- Acetaminophen 325 mg /Butalbital 50mg /Caffeine 40 mg Capsule: Oral
- Acetaminophen 500 mg /Butalbital 50mg /Caffeine 40 mg Capsule: Oral
- Acetaminophen 750 mg /Butalbital 50mg /Caffeine 40 mg Capsule: Oral
- Acetaminophen 325mg /Butalbital 50mg /Caffeine 40 mg Capsule: Oral Solution /15 ml
Fioricet side effects
Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop using this medicine and call your doctor at once if you have:
- confusion, seizure (convulsions);
- shortness of breath;
- a light-headed feeling, like you might pass out; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Fioricet side effects may include:
- drowsiness, dizziness;
- feeling anxious or restless;
- drunk feeling; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Acetaminophen, Butalbital, Caffeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- stomach pain
If you experience any of the following symptoms, call your doctor immediately:
- skin rash
- difficulty breathing
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand names of combination products
- Alagesic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Americet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Anolor® (containing Acetaminophen, Butalbital, Caffeine)¶
- Anoquan® (containing Acetaminophen, Butalbital, Caffeine)¶
- Arcet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Dolgic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Dolmar® (containing Acetaminophen, Butalbital, Caffeine)¶
- Endolor® (containing Acetaminophen, Butalbital, Caffeine)¶
- Esgic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Esgic® Plus (containing Acetaminophen, Butalbital, Caffeine)
- Ezol® (containing Acetaminophen, Butalbital, Caffeine)¶
- Femcet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Fioricet® (containing Acetaminophen, Butalbital, Caffeine)
- Fiorpap® (containing Acetaminophen, Butalbital, Caffeine)¶
- G-1® (containing Acetaminophen, Butalbital, Caffeine)¶
- Geone® (containing Acetaminophen, Butalbital, Caffeine)¶
- Ide-cet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Isocet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Margesic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Medigesic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Minotal® (containing Acetaminophen, Butalbital, Caffeine)¶
- Mygracet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Nonbac® (containing Acetaminophen, Butalbital, Caffeine)¶
- Orbivan® (containing Acetaminophen, Butalbital, Caffeine)¶
- Pacaps® (containing Acetaminophen, Butalbital, Caffeine)¶
- Pharmagesic® (containing Acetaminophen, Butalbital, Caffeine)¶
- Quala Cet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Repan® (containing Acetaminophen, Butalbital, Caffeine)¶
- Tenake® (containing Acetaminophen, Butalbital, Caffeine)¶
- Tencet® (containing Acetaminophen, Butalbital, Caffeine)¶
- Triad® (containing Acetaminophen, Butalbital, Caffeine)¶
- Two-Dyne® (containing Acetaminophen, Butalbital, Caffeine)¶
- Zebutal® (containing Acetaminophen, Butalbital, Caffeine)¶
- Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
- Phrenilin® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
¶This branded product is no longer on the market. Generic alternatives may be available.
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