Butalbital, acetaminophen, and caffeine

Fioricet® is a prescribed medicine that is used to treat severe tension headaches.

This medication is made up of butalbital, acetaminophen, and caffeine.

How do I take this medicine?

Take with a glass of water or other liquid. You can take this medicine with or without food. If you notice that this medicine causes you an upset stomach, take with food.

To take Fioricet, follow the instructions on your prescription bottle.

What are the side effects?

Fioricet often causes sleepiness, dizziness, and feeling drunk. Other less common side effects include abdominal pain, confusion, shakiness, and constipation. Fioricet can also be addictive.

While side effects can be tough, there are ways to manage them. Talk to your care team if any of these side effects are interfering with your life.

How can I be safe when taking this medicine?

Butalbital, acetaminophen, and caffeine Warning

One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.

Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.

Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.

Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.

How to Use ?

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

Fioricet Side Effects

Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • mental/mood changes
  • fainting
  • seizures
  • fast/irregular heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Fioricet Precaution

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • severe breathing problems (such as bronchopneumonia)
  • a certain enzyme disorder (porphyria)
  • liver disease
  • kidney disease
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
  • mental/mood disorders
  • abdominal/stomach problems (such as stomach ulcer)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/nonstop crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Fioricet Interaction

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include:

  • darunavir
  • sodium oxybate
  • isoniazid
  • ketoconazole
  • levoketoconazole
  • lithium
  • phenothiazines (such as chlorpromazine)

This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include doxycycline, estrogen, felodipine, lonafarnib, quinidine, rilpivirine, tamoxifen, theophylline, voriconazole, “blood thinners” (such as warfarin), certain beta blockers (such as metoprolol), corticosteroids (such as prednisone), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain caffeine or ingredients that cause drowsiness. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Fioricet Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine.


Should You Take Fioricet For Migraine?

If you suffer from migraine, then episodes can be completely incapacitating and last several days. This can impact work, school, personal relationships, and recreation activities.

Mikart Fioricet
Mikart Fioricet

Most people with migraine take medication to manage these symptoms, along with making lifestyle changes to avoid migraine triggers (which often include certain foods, stress, flashing lights, etc.). Even with proper care, however, migraine can remain disruptive in a person’s life, resulting in time away from work and difficulty scheduling and attending planned events.

Some people treat their migraine with a medication called Fioricet, which is typically prescribed for tension headaches caused by muscle contractions. However, Fioricet is sometimes given as an off-label treatment for migraine or obtained directly over the internet.

What is Fioricet?

Fioricet is known as a combination medicine in that it contains more than one medication. Specifically, Fioricet contains acetaminophen, butalbital, and caffeine.

Caffeine and acetaminophen work for pain relief, while butalbital induces relaxation, thus relaxing the muscle contractions that cause tension headaches. The drug is quite effective for occasional use to treat severe tension headaches that might be disrupting a person’s life.

There are a number of other brands that have the same active ingredients, including:

  • Alagesic

  • Americet

  • Anolor

  • Anoquan

  • Arcet

  • Dolgic

  • Dolmar

  • Endolor

  • Esgic

  • Ezol

  • Femcet

  • Fiorpap

  • G-1

  • Ide-cet

  • Isocet

  • Margesic

  • Medigesic

  • Minotal

  • Mygracet

  • Nonbac

  • Pacaps

  • Pharmagesic

  • Quala Cet

  • Repan

  • Tenake

  • Tencet

  • Triad

  • Two-Dyne

  • Zebutal

These other brands may contain different inactive ingredients, however, which can potentially help avoid allergies or migraine triggers that might be included in the medication.

Why is Fioricet used to treat migraines?

Fioricet is prescribed to treat both migraine and tension-type headaches, although it has not been approved to treat migraines specifically. Fioricet is not often used as an initial medication, but it can be prescribed off-label for migraine in some cases.

Only a  subset of people¹ report benefits, and those people are typically non-responders to more mainstream medication. Butalbital can also reduce anxiety and thus help with migraines that are caused by stress. However, it can also present other issues, including physical addiction.

Because of this, some doctors prescribe Fioricet or similar medication only to people who do not respond to triptans, although it can have a solid benefit for those who need it. However, doctors have to be careful to avoid dependency. The approved use for tension headaches is typically far more occasional and thus less likely to lead to overuse of the medication.

How do you take Fioricet?

Fioricet is taken orally, as a capsule or tablet, as a treatment for acute migraine. It plays no role in preventing migraine. You should take it only if you feel an attack or episode coming on. Typically, you take one tablet or capsule as needed every four hours, and no more than six tablets in a 24-hour period.

Never take more Fioricet than your doctor recommends, and do not take it because you are afraid you might be exposed to a trigger. It is very easy to overdose on this medication, and the overdose risks are high, including potentially fatal reactions.

Side effects of taking Fioricet

Known side effects of Fioricet include:

  • Drowsiness

  • Nausea and vomiting

  • Lightheadedness

  • Depression

  • Stomach pain

  • Confusion

  • Fatigue

  • Dizziness

People can also be allergic to one or more ingredients in Fioricet. Needless to say, you should not take Fioricet if you know you are allergic to caffeine. It should be taken with food or milk, which can be challenging for those whose migraine is accompanied by nausea.

Can Fioricet interact with other medications?

Fioricet can interact with a number of medications.

It is contraindicated with doravirine, fostemsavir, isavuconazonium sulfate, isocarboxazid, linezolid, lonafarnib, lorlatinib, mavacamten, and phenelzine.

It interacts with several other medications, including ergotamine, fentanyl, heparin, statins, clonazepam, cortisone, conjugated estrogens, birth control, hydrocortisone, etc. You should not drink caffeine-containing beverages or alcohol when taking Fioricet.

The list of interactions is extremely long, which is another reason why Fioricet is not a first-line medication for migraine treatment.

Risks from taking fioricet for migraine

In addition to hundreds of potential drug interactions, taking Fioricet does carry some other risks that you need to discuss with your doctor.

What should I do if I overdose?

It is relatively easy to overdose on Fioricet. An overdose can cause caffeine toxicity, which seldom happens due to the normal consumption of food and caffeinated beverages. Overdosing can cause seizures, weakness, confusion, trouble breathing, and severe liver damage.

Other symptoms might include ringing in the ears, unusual heartbeat, trouble walking or sleeping, and slurred speech.

If you have taken too much of this medicine, call the poison control center at 800-222-1222. You may need to go to the emergency room. Fioricet overdose can be serious, and there have been instances of people intentionally overdosing.

Fioricet should be stored out of the reach of children and pets.

What if I have an allergic reaction?

Allergy symptoms include itching, skin rash, and difficulty breathing. You should call your doctor immediately if you experience these symptoms. Rarely, acetaminophen can cause Stevens-Johnson Syndrome,² a serious allergic reaction that causes inflammation of the skin and detachment of the upper surface.

Because of this, any skin reaction to Fioricet needs to be taken seriously. Do not take any more of the medication and call your doctor right away. This reaction can happen even if you have taken acetaminophen before.

Barbiturates can also cause potentially fatal skin reactions so, again, make sure that you get any kind of skin reaction checked by a healthcare professional immediately. Conditions such as Stevens-Johnson Syndrome and similar toxic epidermal necrolysis are associated with significant morbidity and mortality.

These conditions require early detection and care, so check your skin regularly if you are taking this medication and pay attention to any rash or lesions.

Other allergic symptoms should also warrant a call to your doctor. Most likely, you will have to discontinue the medication and switch to an alternative. You should not take Fioricet if you have previously had any reaction to acetaminophen or to caffeine.

Is Fioricet safe for pregnant women?

You should not take Fioricet if you are pregnant. Butalbital is potentially associated with certain congenital heart defects, namely:

  1. Tetralogy of Fallot: This is a complex of four cardiac and pulmonary defects. Many infants with this condition require surgery soon after birth as it increases the risk of arrhythmia and endocarditis and causes developmental delays.

  2. Pulmonary valve stenosis: This is a narrowing of the valve that controls blood flow to the lungs, causing the right ventricle to have to pump harder, which can cause damage to the heart over time.

  3. Secundum-type atrial septal defect (ASD): This is a hole in the wall between the two atriums of the heart, allowing blood to flow between the two atriums, which can affect blood oxygen levels. Small defects generally go untreated and often close on their own, but larger ones may need a procedure to lower the risk of abnormal heart rhythms, heart failure, heart infection, stroke, and pulmonary hypertension.

The connection has not been formally proven due to the small sample sizes in available studies. However, given it is statistically significant, Fioricet should be avoided while pregnant and breastfeeding, as it does pass into breast milk.

If you get migraines and become pregnant, you should talk to your doctor. Other migraine medications can also carry risks during pregnancy and you may need your medications adjusted.

Is Fioricet addictive?

Both butalbital and caffeine can be physically addictive. It is very possible to become addicted to Fioricet, which is another reason it is not a front-line treatment. Because people with migraine get headaches fairly regularly, they have a higher risk of becoming addicted to Fioricet and/or its ingredients.

Barbiturates, in particular, can be a drug of abuse. This is important to note as Fioricet is sometimes taken to help people sleep, reduce stress, or self-medicate anxiety or depression.

People with mental health issues or a history of substance use disorder are more likely to abuse Fioricet. In fact, these factors are considered potential contraindications for prescribing Fioricet. This includes alcoholism, especially as mixing alcohol and Fioricet can cause extreme drowsiness and impaired judgment.

Withdrawal Symptoms

Regular use can cause rebound headaches, which are highly unpleasant and may not always respond to normal treatments. You should not use Fioricet on a daily basis in order to avoid this. Rebound headaches are caused by physical dependence on the drug to control pain and/or by physical addiction to caffeine, which results in headaches as a withdrawal symptom.

Caffeine withdrawal can also cause fatigue, low energy, depression, drowsiness, concentration issues, brain fog, and irritability. If you are prone to caffeine addiction, you need to be aware that Fioricet can cause or aggravate it due to a large amount of caffeine in the drug.

Barbiturates can cause a withdrawal state similar to alcohol, including seizures and delirium. Usually, people get addicted to Fioricet after ordering it online to self-medicate for chronic headaches, without realizing that it should not be taken daily. There are substantiated cases of people taking Fioricet for migraine and becoming addicted.

Additionally, much like alcohol, the more of the drug you take, the more you need to get the same effect, which can cause an overdose. You should talk to your doctor if Fioricet is no longer working as well as when you first started taking it. This can be a sign of physical dependence and may mean you need to stop taking the drug before you become tempted to take excessively large doses.

Common withdrawal symptoms of Fioricet include:

  • Depression

  • Anxiety

  • Insomnia

  • Hallucinations

  • Increased heart rate

  • Increased sweating

  • Nausea

  • Seizures

People who have become addicted to Fioricet may require detox and rehab to help them get through the withdrawal symptoms. It is very important not to take this medication other than when you truly need it. As you can get a little bit high from Fioricet, the temptation for recreational abuse is present.

Fioricet vs. other migraine medications

The prescription of Fioricet for migraine is off-label. That is, it is not approved for treating migraine in the United States, but doctors may still prescribe it in some circumstances. Most doctors consider there to be better options.

Because of all the issues listed above, Fioricet is most often used as a medication of last resort to treat people who have not responded to other migraine medications. There is an array of other migraine medications available, and almost all of them are better and safer than Fioricet, although many are more expensive.

Fioricet should not be taken daily, so it is a poor choice for chronic migraine.

Mainstream medications used to treat migraines include:

  • Regular over-the-counter painkillers taken as needed

  • Caffeine

  • Triptans, specific to migraine

  • Antiemetics used to treat migraine that comes with nausea

  • Botox, for chronic migraine

A non-drug treatment sometimes used for migraine is transcranial magnetic stimulation³ (TMS). Studies show that TMS is significantly effective for acute migraine but has little to no effect on chronic migraine. More research is needed. However, TMS is generally safe and may be worth discussing with your doctor.

Combination drugs are also commonly used. These are called migraine cocktails and are prescribed especially for severe acute migraine.

Even better is to try and identify and avoid your migraine triggers so you don’t have to take medication as often. This can be easier for some people than for others.

Precautions when taking Fioricet

Consider the issues already mentioned. Never take more Fioricet than required, don’t take it every day, and keep it away from children and pets.

Additionally, Fioricet is contraindicated during pregnancy and for:

  1. People with porphyria

  2. People with a history of depression and suicidal thoughts

  3. People with a history of substance use disorder or alcoholism

  4. People with asthma, emphysema, or other lung diseases

  5. People with kidney, liver, or stomach problems

  6. Older adults in general

  7. People with sleep apne

  8. People with a significant cardiovascular impairment such as congestive heart failure

  9. People with high blood pressure

  10. People with phenylketonuria

You should not drink alcohol when taking Fioricet as the combination can be extremely sedating and may potentially knock you out. It can also increase the risk of liver damage and toxicity.

Do not drive or operate heavy machinery after taking Fioricet as it can impact your ability to stay focused and alert for several hours after taking a dose. Avoid doing any tasks that require mental focus, and don’t sign any binding legal documents due to the risk of impaired judgment.

When to visit a doctor

Don’t attempt to obtain Fioricet online without a prescription. Due to the large numbers of interactions, some severe, with other drugs as well as the potential for addiction, self-medicating with Fioricet is highly dangerous.

If you are taking Fioricet, you should seek medical help if:

  1. Your headaches are worsening in frequency or intensity

  2. You have any kind of skin reaction to the medication

  3. The medication is no longer working as it once did

  4. You have any kind of allergic reaction

You should call your doctor right away if you discover that you are pregnant, due to the potential risk of cardiac birth defects, to discuss whether you should continue taking Fioricet or switch to an alternative.

In general, your doctor will only prescribe Fioricet when other medications have not worked.

The lowdown

Fioricet is a medication approved for tension headaches that is sometimes prescribed for migraines. However, it is not an initial treatment migraine drug due to lower efficacy (except in people who don’t respond to other medications), the risks of overdose and addiction, and the large number of drug interactions.

Typically, your doctor will only prescribe Fioricet if absolutely necessary, and you should not seek it out on your own. There are many better medication options for people with migraine that you and your doctor can explore.

What is fioricet ?

Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Mikart Fioricet
Mikart Fioricet

Fioricet is used to treat tension headaches that are caused by muscle contractions.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts at cannabinoid receptors, contrary to popular belief it is not an antiinflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours

US Brand Name

      1. Anolor 300
      2. Dolgic LQ
      3. Esgic
      4. Esgic-Plus
      5. Ezol
      6. Fioricet
      7. Geone
      8. Margesic
      9. Medigesic
      10. Nonbac
      11. Pacaps
      12. Repan


Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

    • Tablet
    • Capsule
    • Solution