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Fioricet

Generic name: acetaminophen, butalbital, and caffeinea-SEET-a-MIN-oh-fen, bue-TAL-bi-tal, and-KAF-een ]
Drug class: Analgesic combinations

Medically reviewed by Sanjai Sinha, MD. Last updated on Mar 16, 2022.

What is Fioricet?

Fioricet capsules contain 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.

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

Extended and repeated use of Fioricet is not recommended because of the potential for physical dependence.

Warnings

You should not use Fioricet if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use Fioricet if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Fioricet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

Do not use Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use Fioricet if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other opioids.

To make sure Fioricet is safe for you, tell your doctor if you have ever had:

It is not known whether Fioricet will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Fioricet is not approved for use by anyone younger than 12 years old.

How should I take Fioricet?

Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Dosing information

Usual Adult Dose for Headache:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache:

12 years or older: Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, butalbital, and caffeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What should I avoid while taking Fioricet?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

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, a seizure;

  • 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 include:

  • drowsiness, dizziness;

  • feeling light-headed;

  • nausea, vomiting, stomach pain;

  • drunk feeling; or

  • shortness of breath.

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.

What other drugs will affect Fioricet?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fioricet with a sleeping pill, opioid pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Popular FAQ

Is Fioricet a controlled substance?

According to the Drug Enforcement Administration (DEA), Fioricet is not a controlled substance. However, butalbital belongs to a class of drugs known as barbiturates. These drugs are habit-forming and can be abused. For this reason, it’s not recommended to take Fioricet long-term.

Is Fioricet the same as Excedrin?

Fioricet is not the same as Excedrin. Fioricet contains butalbital, which is available by prescription only. Excedrin products are available over the counter and contain different combinations of aspirin, acetaminophen, caffeine and diphenhydramine:

  Excedrin Extra Strength Excedrin Migraine Excedrin Tension Headache Excedrin PM Headache
Acetaminophen 250 mg 250 mg 500 mg 250 mg
Aspirin 250 mg 250 mg   250 mg
Caffeine 65 mg 65 mg 65 mg  
Diphenhydramine       38 mg

 

Is it OK to take Fioricet every day?

Because butalbital is habit-forming, it is not recommended to take Fioricet every day. It’s possible to build up a tolerance to butalbital. Over time, higher doses may be needed to have the same effect, leading to drug dependence. Taking higher doses of Fioricet can also increase the chance of an overdose.

Fioricet is intended for occasional use every 4 hours when symptoms occur.

Does Fioricet make you sleepy?

Butalbital affects the central nervous system and can make you sleepy. It can also cause lightheadedness, dizziness and mental confusion. Drowsiness is also one of the first signs of an overdose from barbiturates.

How long does Fioricet stay in your system?

Fioricet contains three different drugs. Each drug is estimated to stay in your body for a different amount of time.

  • Acetaminophen is eliminated after about 6 to 15 hours
  • Caffeine is eliminated after about 15 hours
  • Butalbital is eliminated after about 7 days

How much caffeine is in Fioricet?

Fioricet contains 40 mg of caffeine, similar to a cup of tea. The following shows the average amount of caffeine in some common beverages:

  • 8 oz of coffee: 80 to 100 mg of caffeine
  • 8 oz green or black tea: 30 to 50 mg of caffeine
  • 12 oz caffeinated soda: 30 to 40 mg of caffeine

Does Fioricet cause weight loss?

In clinical studies, weight loss was not a reported side effect from Fioricet. However, it can cause nausea, vomiting and stomach pain. Having those side effects may lead to a decreased appetite and lead to weight loss.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fioricet only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.