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Overview: Butalbital/aspirin/caffeine/codeine is used for tension headaches. It slows down your nervous system, blocks pain signals, 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/codeine used for?

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

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

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

Butalbital, aspirin, caffeine, and codeine 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. Codeine works by attaching to specific receptors in the body to reduce the feeling of pain.

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

Dosage forms and strengths

  • 50 mg/325 mg/40 mg/30 mg oral capsules

How should I store butalbital/aspirin/caffeine/codeine?

Butalbital/aspirin/caffeine/codeine 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/codeine?

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

  • Nausea, vomiting, or constipation
  • Stomach pain
  • Drowsiness or tiredness
  • Dizziness

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

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

Severe Allergic Reactions. Butalbital/aspirin/caffeine/codeine 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)

Risk of Misuse and Addiction. Misusing butalbital/aspirin/caffeine/codeine 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 butalbital/aspirin/caffeine/codeine exactly as prescribed. Tell your health care provider if you feel that butalbital/aspirin/caffeine/codeine 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

Breathing Problems. Butalbital/aspirin/caffeine/codeine may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your health care provider if you develop severe sleepiness or trouble breathing, especially when you start butalbital/aspirin/caffeine/codeine or when your dose is increased. Get emergency help if you have any of the following symptoms.

  • Changes in the color of your skin, including bluish color to your lips and fingernails
  • Confusion
  • Shortness of breath
  • Feeling dizzy, lightheaded, or fainting
  • Changes in your heart rate or rhythm, such as a fast, slow, pounding, or skipping heartbeat 
  • Slow or shallow breathing
  • Excessive sleepiness or trouble staying awake

 

Increased Pain Sensitivity (Hyperalgesia). Butalbital/aspirin/caffeine/codeine can cause an increased sensitivity to pain. It can cause things that normally cause pain to feel more painful than usual. Butalbital/aspirin/caffeine/codeine can also cause allodynia. This happens when things that normally do not cause pain, such as wearing glasses or brushing your hair, become painful. If your pain increases, do not take extra doses of butalbital/aspirin/caffeine/codeine. This could cause you to overdose or develop other serious side effects. Call your health care provider right away if your pain increases, you feel more sensitive to pain, or if you develop pain in other areas of the body. 

Reduced Adrenal Function. Long-term use of butalbital/aspirin/caffeine/codeine can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

Low Blood Pressure (Hypotension). Butalbital/aspirin/caffeine/codeine may cause low blood pressure. If you feel faint or dizzy, lie down. Tell your health care provider right away if you have any of the following symptoms of low blood pressure.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Feeling weak or tired

Sphincter of Oddi Spasm. The sphincter of Oddi is a muscular valve in your body that controls the flow of bile and digestive juices from the pancreas into the small intestine. When this valve spasms, it may feel like getting a tight muscle cramp, causing pain and blocking the flow of these juices, which can lead to discomfort and digestive problems. This is more likely to happen if you do not have a gallbladder. Stop taking butalbital/aspirin/caffeine/codeine and get emergency medical help if you have new or worse stomach pain or pain in the upper right side of your stomach-area that travels to your back or shoulder, with or without nausea and vomiting.

Stomach Bleeding. Butalbital/aspirin/caffeine/codeine 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/codeine 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/codeine 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

Seizures. Some people who have taken butalbital/aspirin/caffeine/codeine have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking butalbital/aspirin/caffeine/codeine and call your health care provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Severe Bleeding. Butalbital/aspirin/caffeine/codeine 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/codeine.

  • 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

Severe Skin Reactions. Butalbital/aspirin/caffeine/codeine can cause severe skin reactions, such as toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop butalbital/aspirin/caffeine/codeine 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

Warnings & Precautions

Who should not use butalbital/aspirin/caffeine/codeine?

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

  • Butalbital
  • Aspirin
  • Caffeine
  • Codeine
  • Fiorinal with codeine
  • Any other medicine known as a nonsteroidal anti-inflammatory drug (NSAID)
  • Any of the ingredients in the specific product dispensed

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

Children. Butalbital/aspirin/caffeine/codeine should not be used in any child younger than 12 or in a child younger than 18 after a surgery to remove their tonsils or adenoids (tonsillectomy and/or adenoidectomy). Slow or shallow breathing that can lead to death may occur. 

Lung Problems. Butalbital/aspirin/caffeine/codeine should not be used if you have severe asthma, trouble breathing, or other lung problems.

Syndrome of Asthma, Rhinitis, and Nasal Polyps. People with all of these things should not take butalbital/aspirin/caffeine/codeine.

Drug Interactions. Butalbital/aspirin/caffeine/codeine should not be taken while you are using certain other medicines. Before taking butalbital/aspirin/caffeine/codeine, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have used recently. See the Interactions section for more details.

Gut Blockage. Butalbital/aspirin/caffeine/codeine should not be used if you have a blockage of your gut (bowel obstruction) or a narrowing of the stomach or intestines. 

Slowed Gut Movement. Paralytic ileus is a type of ileus where your intestines are unable to move food through them.

Blood Clotting Problems. Butalbital/aspirin/caffeine/codeine should not be used if you have a condition in which your blood does not clot properly, such as hemophilia.

Viral Infection. Butalbital/aspirin/caffeine/codeine should not be taken during a viral infection, such as the flu or chickenpox. This can 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 know about butalbital/aspirin/caffeine/codeine before using it?

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

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

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

If you have been taking butalbital/aspirin/caffeine/codeine 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.

  • Feeling restless
  • Watery eyes or runny nose
  • Yawning
  • Sweating or chills
  • Muscle, joint, or back pain
  • Dilated pupils 
  • Irritability, anxiety, or trouble sleeping
  • Nausea, vomiting, diarrhea, or loss of appetite
  • Increase in blood pressure, breathing rate, or heart rate

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

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

Dispose of expired, unwanted, or unused butalbital/aspirin/caffeine/codeine right away by taking your medicine to an authorized DEA-registered collector or drug take back program. If one is not available, you can mix medicine with dirt, coffee grounds, or cat litter, then place the mixture in a sealed plastic bag and throw the bag in the trash. 

Long-term use of butalbital/aspirin/caffeine/codeine may affect your ability to become pregnant or get a partner pregnant. Talk with your health care provider if you have any concerns.

Your health care provider may ask you to have naloxone, a medicine used to reverse the effects of codeine, on hand in case of an emergency. Make sure that you and a caregiver know how to use naloxone. If you have any questions, talk to your health care provider or pharmacist. 

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

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/codeine 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. 

  • Brain tumor or head injury
  • Seizures
  • Liver, kidney, or thyroid problems
  • Stomach, pancreas, or gallbladder problems
  • Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
  • Obstructive sleep apnea
  • Problems peeing 
  • Opioid overdose
  • Mental health problems
  • Recent or upcoming surgery to remove your tonsils or adenoids
  • Any genetic conditions that affect how your body metabolizes medicines

Pregnancy. Do not take butalbital/aspirin/caffeine/codeine at 20 weeks or later in pregnancy without talking to your health care provider. Taking butalbital/aspirin/caffeine/codeine 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 use butalbital/aspirin/caffeine/codeine while you are pregnant or trying to get pregnant.

Breastfeeding. Butalbital/aspirin/caffeine/codeine 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/codeine.

Interactions

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

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

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

Does butalbital/aspirin/caffeine/codeine 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/codeine.

  • A monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s disease
  • An opioid, such as codeine, fentanyl, oxycodone, or morphine, which is a medicine used for certain types of pain
  • A mixed agonist/antagonist or partial agonist opioid analgesic, such as buprenorphine (Butrans, Sublocade), butorphanol, and others, which is used to treat certain types of pain or opioid use disorder
  • A selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), or tricyclic antidepressant, which are medicines commonly used for anxiety and depression
  • A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A triptan, such as eletriptan (Relpax), sumatriptan (Imitrex and others), and others, which is a medicine commonly used to treat migraine
  • An antipsychotic, which is a medicine for certain mental health conditions
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, muscle relaxers, and medicines for anxiety
  • Amphotericin B, fluconazole (Diflucan), ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which are used for fungal infections
  • A protease inhibitor, such as nelfinavir (Viracept) or ritonavir (Norvir), which is a medicine commonly used to treat HIV
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • Probenecid, which is a medicine commonly used for gout
  • A carbonic anhydrase inhibitor, such as acetazolamide (Diamox) or methazolamide
  • Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • An angiotensin-converting enzyme (ACE) inhibitor, such as captopril or ramipril , which is a medicine for high blood pressure, heart failure, and certain kidney problems
  • A beta-blocker, such as metoprolol (Lopressor, Toprol XL, and others) or propranolol (Inderal LA, Innopran XL), which is a medicine used for certain heart conditions or to reduce blood pressure
  • Any medicine for diabetes
  • Any medicine for seizures, such as carbamazepine, phenytoin, or valproic acid
  • 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
  • A corticosteroid, which is a medicine for certain inflammatory conditions

Many other medicines may alter the blood levels of butalbital/aspirin/caffeine/codeine. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with butalbital/aspirin/caffeine/codeine. 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/codeine?

If you or someone else has used too much butalbital/aspirin/caffeine/codeine, 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/codeine?

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.