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Overview: Butalbital/aspirin/caffeine is used for tension headaches. It slows down your nervous system and reduces inflammation, swelling, and 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/aspirin/caffeine used for?

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

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

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

Butalbital, aspirin, 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. Aspirin works by reducing inflammation and swelling. Caffeine helps decrease the size of blood vessels in the head, which reduces excess blood flow.

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

Dosage forms and strengths

  • 50 mg/325 mg/40 mg oral capsules

How should I store butalbital/aspirin/caffeine?

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

Side Effects

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

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

  • Drowsiness
  • Dizziness or lightheadedness
  • Nausea, vomiting, or gas

There may be other side effects of butalbital/aspirin/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. 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/aspirin/caffeine?

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

Severe Allergic Reactions. Butalbital/aspirin/caffeine may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes 
  • Swelling of the face, lips, mouth, tongue, or throat 
  • Shortness of breath, trouble swallowing, or throat tightness 
  • Swelling in your feet, ankles, or legs 
  • Nausea or vomiting 
  • Dizziness, feeling lightheaded, or fainting 
  • Stomach cramps 
  • Joint pain 
  • Dark-colored pee 
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Butalbital/aspirin/caffeine can cause severe skin reactions called toxic epidermal necrolysis (TEN) and erythema multiforme that can lead to death if not treated. If you develop a rash, stop butalbital/aspirin/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
  • Painful, itchy rash that looks like a bull’s-eye or a target
  • Fever or general ill feeling 

Severe Bleeding. Butalbital/aspirin/caffeine can increase your risk of severe bleeding that can lead to death. Some patients with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking butalbital/aspirin/caffeine.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots

Stomach Bleeding. Butalbital/aspirin/caffeine can increase your risk of bleeding, ulcers, and tears (perforation) in your gut. The risk is higher if you have a history of stomach ulcers, bleeding problems, take higher doses of butalbital/aspirin/caffeine or take it for longer than directed, have poor health, are age 60 or older, have liver disease, smoke, drink alcohol, or take certain other medicines. Stop taking butalbital/aspirin/caffeine and get emergency help if you have any of the following symptoms.

  • Vomit blood
  • Black or tarry poop
  • Stomach pain that does not go away
  • Upset stomach
  • Feel faint

Risk of Misuse and Addiction. Misusing butalbital/aspirin/caffeine can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take this medicine exactly as prescribed. Tell your health care provider if you feel that butalbital/aspirin/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/aspirin/caffeine?

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

  • Butalbital
  • Aspirin
  • Caffeine
  • Fiorinal
  • Any of the ingredients in the specific product dispensed

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

Blood Clotting Problems. Butalbital/aspirin/caffeine should not be used if you have a condition in which your blood does not clot properly, such as hemophilia, low platelet levels (thrombocytopenia), von Willebrand disease, or severe vitamin K deficiency. 

Stomach or Intestinal Ulcers. Butalbital/aspirin/caffeine should not be used if you have ulcers, tears (perforation), or other lesions in your digestive system. 

Porphyria. Butalbital/aspirin/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 can not make heme properly, certain chemicals build up and cause nerve or skin problems.

Nasal Polyps, Angioedema, and Wheezing or Trouble Breathing After Aspirin or Medicines Like Ibuprofen or Naproxen (Nonsteroidal Anti-inflammatory Drugs). People with all of these things should not take butalbital/aspirin/caffeine.

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

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

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

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

If you take butalbital/aspirin/caffeine on a regular basis, do not stop taking the medicine without talking to your health care provider. Stopping too quickly can 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 to your environment

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

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

Tell your health care provider if you have the flu or chickenpox. Taking butalbital/aspirin/caffeine during certain viral infections may put you at risk for a rare but serious condition called Reye’s syndrome, especially if you are 18 years of age or younger.

What should I tell my health care provider before using butalbital/aspirin/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 determine if butalbital/aspirin/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 or 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.

Other Medicines and Supplements. Butalbital/aspirin/caffeine may interact with other medicines and supplements. Before taking butalbital/aspirin/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. Do not take butalbital/aspirin/caffeine at 20 weeks or later in pregnancy without talking to your health care provider. Taking butalbital/aspirin/caffeine during this time may cause harm to an unborn baby and complications during delivery. Tell your health care provider if you are or plan to become pregnant. Your health care provider will advise you if you should take butalbital/aspirin/caffeine while you are pregnant or trying to get pregnant.

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

Interactions

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

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

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

Does butalbital/aspirin/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/aspirin/caffeine.

  • A monoamine oxidase inhibitor (MAOI), which is a medicine usually used for depression or Parkinson’s disease
  • A corticosteroid, which is a medicine for certain inflammatory conditions
  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • A medicine for diabetes
  • 6-mercaptopurine, which is a medicine commonly used for certain types of cancer
  • Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
  • Probenecid, which is a medicine commonly used for gout
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • An opioid, such as codeine, fentanyl, oxycodone, or morphine, 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/aspirin/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/aspirin/caffeine?

If you or someone else has used too much butalbital/aspirin/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/aspirin/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.