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Overview: Butalbital/acetaminophen/caffeine is used for tension headaches. It slows down your nervous system, blocks pain signals, and reduces excess blood flow to help with tension headaches. Common side effects include dizziness and drowsiness. Do not drive or do other activities that require alertness or coordination until you know how this medicine affects you.

Uses

What is butalbital/acetaminophen/caffeine used for?

Butalbital/acetaminophen/caffeine is commonly used to help relieve tension headaches, which can be caused by tight or tense muscles.

Butalbital/acetaminophen/caffeine may also be used for other conditions as determined by your health care provider.

How does butalbital/acetaminophen/caffeine work (mechanism of action)?

Butalbital, acetaminophen, and caffeine work in different ways to relieve a tension headache. Butalbital is a barbiturate that works by slowing down your brain and nervous system. Acetaminophen may work by blocking pain signals. Caffeine helps decrease the size of blood vessels in the head, which reduces excess blood flow.

How is butalbital/acetaminophen/caffeine supplied (dosage forms)?

Dosage forms and strengths

  • 50 mg/300 mg/40 mg oral capsules
  • 50 mg/325 mg/40 mg oral capsules
  • 50 mg/325 mg/40 mg oral tablets

How should I store butalbital/acetaminophen/caffeine?

Butalbital/acetaminophen/caffeine should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store it in a cool, dry place.

Side Effects

What are the most common side effects of butalbital/acetaminophen/caffeine?

The most common side effects of butalbital/acetaminophen/caffeine are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Drowsiness
  • Dizziness or lightheadedness
  • Shortness of breath
  • Nausea or vomiting
  • Stomach pain
  • Intoxicated feeling

There may be other side effects of butalbital/acetaminophen/caffeine that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of butalbital/acetaminophen/caffeine?

While less common, the most serious side effects of butalbital/acetaminophen/caffeine are described below, along with what to do if they happen.

Severe Allergic Reactions. Butalbital/acetaminophen/caffeine may cause allergic reactions, which can be serious. Stop taking butalbital/acetaminophen/caffeine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when you take butalbital/acetaminophen/caffeine. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Butalbital/acetaminophen/caffeine can cause severe skin reactions, called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop butalbital/acetaminophen/caffeine and call your health care provider right away. Get emergency help if you have any of the following symptoms of a severe skin reaction.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Risk of Misuse and Addiction. Misusing butalbital/acetaminophen/caffeine can lead to serious side effects like a coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take butalbital/acetaminophen/caffeine exactly as prescribed. Tell your health care provider if you feel that butalbital/acetaminophen/caffeine is not working. Call your health care provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

  • Sudden confusion or feeling disoriented
  • Feeling paranoid
  • Suicidal thoughts or actions
  • Seizures
  • Trouble breathing

Warnings & Precautions

Who should not use butalbital/acetaminophen/caffeine?

Allergies to Ingredients. People who are allergic to any of the following should not take butalbital/acetaminophen/caffeine.

  • Butalbital
  • Acetaminophen
  • Caffeine
  • Fioricet
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific butalbital/acetaminophen/caffeine products they stock.

Porphyria. Butalbital/acetaminophen/caffeine should not be used if you have porphyria, which is a rare disorder that affects the body’s ability to make a substance called heme. Heme is important for carrying oxygen in the blood. When the body cannot make heme properly, certain chemicals build up and cause nerve or skin problems.

What should I know about butalbital/acetaminophen/caffeine before using it?

Do not take butalbital/acetaminophen/caffeine unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share butalbital/acetaminophen/caffeine with other people, even if they have the same condition as you. It may harm them.

Keep butalbital/acetaminophen/caffeine out of the reach of children. Butalbital/acetaminophen/caffeine is a controlled substance because it can be misused or lead to dependence. Store it in a safe place to protect it from theft. It is illegal to sell or give away this medicine.

If you take butalbital/acetaminophen/caffeine on a regular basis, do not stop taking the medicine without talking to your health care provider. Stopping too quickly may cause serious side effects. Call your health care provider right away if you have any of the following symptoms.

  • Seizures
  • Sudden confusion
  • Lack of awareness of your environment

Butalbital/acetaminophen/caffeine can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how butalbital/acetaminophen/caffeine affects you.

Do not take more than 4,000 mg of acetaminophen per day. Taking too much acetaminophen can cause serious liver problems that could lead to death. Talk to your pharmacist about which medicines contain acetaminophen. It can be found in Tylenol, some cough and cold medicines, some sleep medicines, and others. If you take too much acetaminophen, get emergency help right away, even if you do not feel sick.

People who are 65 years and older can be at greater risk of some side effects from butalbital/acetaminophen/caffeine. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using butalbital/acetaminophen/caffeine?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if butalbital/acetaminophen/caffeine is right for you.

In particular, make sure that you discuss any of the following.

Alcohol Use Disorder or Substance Use Disorder. Talk to your health care provider if you use or used to use street drugs, have or had a problem using alcohol or prescription medicines, or live with someone with this problem. 

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems 
  • Liver problems
  • Stomach problems

Other Medicines and Supplements. Butalbital/acetaminophen/caffeine may interact with other medicines and supplements. Before taking butalbital/acetaminophen/caffeine, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how butalbital/acetaminophen/caffeine could affect pregnancy or harm an unborn baby. Tell your health care provider if you are or plan to become pregnant. If you take butalbital/acetaminophen/caffeine on a regular basis during pregnancy, your baby may have withdrawal symptoms. Tell your health care provider if you took butalbital/acetaminophen/caffeine during your pregnancy, especially near the end of your pregnancy.

Breastfeeding. Butalbital/acetaminophen/caffeine passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop taking butalbital/acetaminophen/caffeine.

Interactions

Does butalbital/acetaminophen/caffeine interact with foods or drinks?

There are no known interactions between butalbital/acetaminophen/caffeine and foods or drinks.

Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol while taking butalbital/acetaminophen/caffeine. Drinking alcohol while taking butalbital/acetaminophen/caffeine can increase your risk of overdose and death.

Does butalbital/acetaminophen/caffeine interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking butalbital/acetaminophen/caffeine.

  • A monoamine oxidase inhibitor (MAOI), which is a medicine usually used for depression or Parkinson’s disease
  • An opioid, such as codeine, fentanyl, morphine, or oxycodone, which is a medicine used for certain types of pain
  • Chlordiazepoxide (Librium), which is a medicine used for anxiety 
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety

This may not be a complete list of medicines that can interact with butalbital/acetaminophen/caffeine. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much butalbital/acetaminophen/caffeine?

If you or someone else has used too much butalbital/acetaminophen/caffeine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of butalbital/acetaminophen/caffeine?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. Do not take more than your prescribed dose.