butalbital / acetaminophen / caffeine
Fioricet is a combination medication containing butalbital, acetaminophen, and caffeine. It's taken by mouth as needed, typically every 4 hours, to treat tension headaches. But it's not a first-choice option because it can become habit-forming and can worsen headaches if taken too frequently. In addition, Fioricet can cause side effects, such as sleepiness and dizziness. It's available as pills and an oral syrup.
What is Fioricet?
What is Fioricet used for?
- Tension headaches
How Fioricet works
Fioricet is a combination of three medications that work together to help relieve headache pain.
- Butalbital is a barbiturate that works by raising the levels of chemicals that cause your brain to relax.
- Acetaminophen is an analgesic. It stops the production of certain chemicals in your brain, which can help relieve pain.
- Caffeine is an adenosine antagonist. It blocks a natural chemical in your body called adenosine. It's unclear exactly how caffeine works to treat headaches, but it's thought to boost the pain-relieving activity of acetaminophen.
Drug facts
Risks and warnings for Fioricet
Fioricet can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
- Risk factors: Drinking alcohol | Taking other medications containing acetaminophen | Taking too much Fioricet | History of liver problems
Taking too much acetaminophen can cause liver damage that can be permanent and life-threatening. For adults, the maximum amount of acetaminophen is 3 or 4 grams in a 24-hour period, depending on your provider's instructions.
Speak to your provider before using Fioricet if you have liver problems since it can cause further damage to your liver. Also, avoid drinking alcohol while taking Fioricet because this combination can harm your liver too.
Signs of liver problems include dark urine, feeling tired, upset stomach or stomach pain, or yellowing of the skin or whites of the eyes. If you notice any of these symptoms, call your provider right away.
Difficulty concentrating and extreme sleepiness
- Risk factors: Taking high doses of Fioricet | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness
Fioricet can cause extreme sleepiness and lower your ability to think, react, and focus. Don't drink alcohol or take other medications that can cause sleepiness or "brain fog", such as pain medications or antidepressants, with Fioricet. Doing so can worsen these side effects. Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider right away if you feel too sleepy from taking Fioricet.
Serious skin or allergic reactions
- Risk factors: History of serious skin reactions | Allergy to acetaminophen (Tylenol)
Fioricet contains acetaminophen (Tylenol), which can rarely cause life-threatening skin reactions and allergic reactions. If you're allergic to acetaminophen, don't take Fioricet. If you develop symptoms of an allergic reaction, such as swelling of the face, mouth, or throat, trouble breathing, itchy red rash (hives), or vomiting, stop taking Fioricet and call for emergency medical help right away. If you develop symptoms of a skin reaction, such as a reddening or peeling of the skin, painful rash, or fluid-filled blisters, stop taking Fioricet and go to the emergency room right away.
Misuse, dependence, and withdrawal
- Risk factors: Taking Fioricet longer than prescribed | Taking higher doses of Fioricet than prescribed | Taking Fioricet more often than prescribed
Fioricet contains butalbital, which can be habit-forming. Misuse of Fioricet can lead to dependence, accidental overdose, and even death. Doing so can also cause withdrawal symptoms, like seizures, restlessness, trouble sleeping, and shakiness, if you lower your dose or stop taking the medication suddenly. To lower the risk of physical dependence, don't take Fioricet longer than prescribed, at higher doses than prescribed, or more often than prescribed.
Call for emergency medical help if you have any symptoms of taking too much butalbital, including sleepiness, trouble breathing, dizziness, confusion, or loss of consciousness. If you no longer want to take Fioricet, talk to your healthcare provider so they can instruct you on how to stop taking the medication safely. Speak to your healthcare provider about alternative treatments if you have concerns about taking Fioricet.
Side effects of Fioricet
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Drowsiness
- Lightheadedness
- Dizziness
- Loss of awareness (sedation)
- Trouble breathing
- Nausea
- Vomiting
- Stomach pain
- Feeling "high" (intoxicated)
Less Common Side Effects
- Headache
- Shaking
- Feeling agitated
- Excessive sweating
- Difficulty swallowing
- Muscle weakness
- Fast heart rate
- Seizures
- Confusion
Fioricet serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Signs of overdose: not responding to sound or touch, extreme sleepiness, slowed breathing, nausea, vomiting, sweating, tiredness, restlessness, shaking, confusion, stomach pain, dark urine, yellowing of your skin or eyes, loss of consciousness
- Withdrawal: seizures, delusions, restlessness, trouble sleeping, shakiness
- Serious allergic reaction: trouble breathing, hives, swelling of the face, mouth, tongue, or throat
- Serious skin reaction: painful skin rash, blisters, skin itching or peeling
The following Fioricet side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Lightheadedness
shortness of breath
Incidence not known
Abdominal or stomach pain
black, tarry stools
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
blurred vision
change in the frequency of urination or amount of urine
chills
difficulty with breathing
difficulty with swallowing
dizziness
drowsiness
fainting
fast, pounding, or irregular heartbeat or pulse
flushed or dry skin
fruit-like breath odor
increased hunger
increased thirst
increased urination
joint or muscle pain
loss of appetite
nausea or vomiting
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
seizures
shakiness in the legs, arms, hands, or feet
sores, ulcers, or white spots in the mouth or on the lips
sweating
swelling of the feet or lower legs
tightness in the chest
trembling or shaking of the hands or feet
troubled breathing
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Confusion as to time, place, or person
dark urine
difficult or painful urination
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
general feeling of discomfort or illness
hallucinations
headache
holding false beliefs that cannot be changed by fact
increased sweating
irregular, fast or slow, or shallow breathing
light-colored stools
loss of appetite
pale or blue lips, fingernails, or skin
restlessness
sudden decrease in the amount of urine
sweating
trouble sleeping
unpleasant breath odor
unusual excitement, nervousness, or restlessness
vomiting of blood
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Relaxed and calm
sleepiness
Incidence not known
bloated
continuing ringing or buzzing or other unexplained noise in the ears
excess air or gas in the stomach or intestines
false or unusual sense of well-being
full feeling
hearing loss
heavy eyelids
high energy
hot spells
hyperventilation
irritability
numbness
pain in the leg
passing gas
sluggishness
tingling sensation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Fioricet
Pros
- Available as a lower-cost, generic medication
- Combination of three medications in a single dosage form (e.g., pill, liquid), which is more convenient
- Available in a liquid form as a fruit punch-flavored syrup
- Can be used in people as young as 12 years old
Cons
- Can cause misuse and physical dependence, so it's a controlled substance in some states
- Not a first-choice medication for treating tension headaches
- Might cause liver damage because of the acetaminophen
- More difficult to customize the dose since it's a combination of three medications
Pharmacist tips for Fioricet
- Fioricet can make you sleepy, dizzy, and lightheaded. Don't drive or use any heavy machinery until you know how the medication affects you.
- Avoid alcohol while taking Fioricet because it can make you more drowsy and dizzy, raise your risk of accidental injuries and liver damage, and worsen headaches
- Take Fioricet exactly as your provider instructed you to. Don't change your dose or stop taking Fioricet without talking to your provider first. To stop the medication, they might need to lower your dose slowly before stopping it completely. This lowers your risk of getting withdrawal symptoms, such as seizures, hallucinations, and worsening of headaches.
- Make sure to tell your provider about all of the medications you're taking before starting Fioricet. Don't start any new medications while taking Fioricet without talking to your provider first to make sure the combination is safe to take.
- Many over-the-counter and prescription medications contain acetaminophen. Don't use other medications containing acetaminophen unless your provider specifically said it was okay for you to do so. Ask your provider or pharmacist if you aren't sure if a certain medication contains acetaminophen.
- Store Fioricet at room temperature in a place out of reach from children due to the life-threatening risk of accidental overdose and misuse. If you don't need to take Fioricet anymore, choose a medication take-back option to get rid of it safely.
- If you or someone you know accidentally overdoses on Fioricet, get emergency medical help or call your local poison control center at 1-800-222-1222 right away.
- For the liquid form: Make sure to only use a medication dose cup or oral syringe from the pharmacy to measure out your dose. Don't use household spoons because they aren't accurate and might cause you to take the wrong dose.
Common questions about Fioricet
Fioricet and Fiorinal are both used to treat tension headaches. Both medications contain butalbital and caffeine, but Fioricet also has acetaminophen whereas Fiorinal contains aspirin. Unlike acetaminophen, aspirin also treats inflammation and swelling. Neither medication is considered a first-choice option for treating tension headaches. Another difference is that while Fiorinal is a schedule III controlled substance, Fioricet might or might not be classified as a controlled substance in your state. This is because Fioricet is currently on the DEA list of exempted prescription products, meaning it's up to the individual states how they regulate it.
Fioricet is a controlled substance in some states. Because it contains butalbital, a medication that can be misused and cause dependence, some state governments place strict regulations on Fioricet. But it's not classified as a controlled substance in all states because it contains acetaminophen. Initially, regulators believed that the acetaminophen in Fioricet discourages people from misusing Fioricet. This is because taking too much acetaminophen can cause harm, such as liver damage. So regulators left it up to the states to decide on how to classify Fioricet. But recent data shows that the acetaminophen in Fioricet might not be enough to stop people from misusing this medication. There's a possibility that the classification of Fioricet might change in the future.
It's recommended to limit caffeine because Fioricet already contains caffeine. The maximum dose of Fioricet is 6 doses per day, which equates to 240 mg of caffeine. For comparison, an 8-ounce cup of coffee contains 95 mg to 165 mg of caffeine. According to the FDA, 400 mg of caffeine is considered a safe amount for adults that won't cause dangerous side effects. Too much caffeine can lead to nervousness, shakiness, restlessness, trouble sleeping, and a fast heart rate. If you experience these symptoms, avoid other sources of caffeine and use the lowest possible amount of Fioricet.
You might be able to take other pain medications, like ibuprofen (Advil, Motrin) or naproxen (Aleve), with Fioricet if you need more relief for your headache. These medications work differently to ease pain and they can help lower the amount of Fioricet you need to relieve your symptoms. Taking less Fioricet means you're not as likely to experience the dangers or side effects of taking this medication. But don't take other medications containing acetaminophen (Tylenol). Fioricet already contains acetaminophen, and you might accidentally take too much acetaminophen if you take these other medications and Fioricet together. This can lead to serious liver damage. Before using other pain medications with Fioricet, speak with your healthcare provider to make sure it's safe for you to do so. Other pain medications still carry risks that shouldn't be ignored (e.g., heart risks, kidney problems).
There haven't been enough strong clinical studies looking at Fioricet and its effects on pregnancy, so it's not completely known how safe it is during pregnancy. A study found that Fioricet could potentially raise the risk of heart problems in unborn babies. In addition, there has been a report of a newborn experiencing withdrawal seizures at birth. This is likely related to the fact the mother took a medication with butalbital during the last two months of pregnancy. If you're pregnant or planning on becoming pregnant, discuss the risks and benefits of using Fioricet with your provider.
It's not known how safe Fioricet is during breastfeeding because it hasn't been well-studied. All three medications in Fioricet can pass into breastmilk in small amounts, but it's unclear how they affect the nursing baby. There has been a report of poor feeding and vomiting in a breastfed baby whose mother who took Fioricet every 6 hours for 24 hours. If you're breastfeeding, let your provider know because it's likely that they'll switch you to a different medication for your headaches.
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Fioricet dosage
Typical dosage for Fioricet
There are several manufacturers and brand names of this medication. The dose might differ slightly and each pill might contain different amounts of acetaminophen depending on which manufacturer and formulation of the medication you're using.
Be sure to check your prescription for specific instructions. In general:
Fioricet and its generic: Each pill contains 50 mg of butalbital, 300 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 1 to 2 capsules by mouth every 4 hours as needed for pain. The maximum dose is 6 capsules in a 24-hour period.
Zebutal, Esgic, and generic tablets: Each pill contains 50 mg of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 1 to 2 capsules or tablets by mouth every 4 hours as needed for pain. Don't take more than 6 pills in a 24-hour period.
Vtol LQ oral solution: Each tablespoonful (15 mL) contains 50 mg of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 15 mL (1 tablespoon) to 30 mL (2 tablespoons) by mouth every 4 hours. Don't take more than 90 mL (6 tablespoons) in a 24-hour period.
Interactions between Fioricet and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Riociguat
- Viloxazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Amobarbital
- Anisindione
- Aprobarbital
- Butabarbital
- Calcium Oxybate
- Capmatinib
- Carisoprodol
- Chloral Hydrate
- Chlordiazepoxide
- Chlorzoxazone
- Clarithromycin
- Clonazepam
- Clorazepate
- Dantrolene
- Darunavir
- Diazepam
- Dicumarol
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Esketamine
- Estazolam
- Ethchlorvynol
- Etonogestrel
- Flunitrazepam
- Flurazepam
- Givosiran
- Halazepam
- Imatinib
- Iobenguane I 131
- Isoniazid
- Ketazolam
- Lorazepam
- Lormetazepam
- Magnesium Oxybate
- Medazepam
- Mephenesin
- Mephobarbital
- Meprobamate
- Metaxalone
- Methocarbamol
- Methohexital
- Midazolam
- Nifedipine
- Nitrazepam
- Oxazepam
- Peginterferon Alfa-2b
- Pentobarbital
- Phenindione
- Phenobarbital
- Phenprocoumon
- Piperaquine
- Pixantrone
- Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
- Potassium Oxybate
- Prazepam
- Primidone
- Quazepam
- Secobarbital
- Sodium Oxybate
- Temazepam
- Thiopental
- Trazodone
- Triazolam
- Ulipristal
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Cannabis
- Carbamazepine
- Fosphenytoin
- Lixisenatide
- Ospemifene
- Phenytoin
- Prednisone
- Warfarin
- Zidovudine
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Fioricet contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Fioricet will not be safe for you to take.
- Porphyria (a condition that affects your skin and nerves)
What are alternatives to Fioricet?
News about Fioricet
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