Butalbital and Aspirin Combination (oral)

The combination of butalbital and aspirin is a pain reliever and relaxant used for treating tension headaches and mild to moderate pain.

Overview

The aspirin and butalbital combination acts as a pain reliever and relaxant for relieving tension headaches. Aspirin helps to reduce headache pain, while butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation. Caffeine, which is usually added in the combination, helps to increase the effects of aspirin. Butalbital belongs to the category of drugs known as barbiturates, which act in CNS (central nervous system) to produce their effects.

If you use butalbital for a prolonged period, your system may get used to it, to the effect that larger amounts will be needed for the same effects. This is referred as tolerance to the medication. Butalbital may also become habit-forming, leading to psychological or physical dependence when used for long or in larger doses. A physical dependence could lead to withdrawal side effects when the patient stops taking the medication. The first symptom for patients who get headaches may be rebound (new) headaches.

Some of these combination medications may also contain caffeine, which plays a part in relieving headaches. You may, however, develop physical dependence with caffeine if you use it for a long time.

Butalbital and aspirin combination may sometimes be used for other types of headaches or relieving other kinds of pain, as your doctor determines. These medications are available only with the doctor's prescription.

Conditions treated:

  • Tension headaches
  • Pain (mild to moderate)

Type of medicine:

  • Barbiturate

Side Effects

Butalbital and aspirin may also bring about certain unwanted effects, besides the desired effects. Remember your doctor will prescribe this medication after weighing its potential benefits against the risks of using it. Stop taking this medicine and get emergency medical attention if you experience any of these side effects:

Less common or rare:

  • Severe dizziness or feeling of faintness
  • Stuffy nose (occurring together with other side effects listed here)
  • Coughing, tightness in chest, troubled breathing, shortness of breath, or wheezing
  • Large hive-like swellings on lips, tongue, eyelids, or face
  • Difficulty swallowing
  • Redness/flushing of skin or bluish discoloration or (appearing together with other side effects listed here)
  • Skin rash, hives or itching

Rare:

  • Tenderness, burning, or peeling of skin
  • Fever with or without chills
  • Bleeding or crusting sores on the lips
  • Sores, white spots or ulcers in mouth (painful)
  • Chest pain
  • Red, thickened, or scaly skin
  • Sore throat (unexplained)
  • Symptoms of overdosing:
  • Stomach pain (severe)
  • Unusual movements of the eyes
  • Fast, slow, irregular, or difficulty with breathing
  • Uncontrollable flapping hand movements, particularly in elderly patients
  • Muscle trembling/twitching (for products with caffeine)
  • Nausea or vomiting (severe or ongoing), sometimes with blood
  • Lightheadedness, dizziness, drowsiness, or weakness (severe)
  • Convulsions (seizures, with products that contain caffeine)
  • Hallucinations (hearing, seeing, or feeling things that are not there)
  • Fast, slow or irregular heartbeat
  • Vision problems
  • Frequent urination (for products that contain caffeine)
  • Staggering
  • Buzzing or ringing in ears (enduring) or hearing loss
  • Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, particularly with products that contain caffeine)
  • Diarrhea (severe or enduring)
  • Slurred speech
  • Seeing flashes of "zig-zag" lights (for products with caffeine)
  • Increased thirst
  • Increased sensitivity to pain or touch (for products with caffeine)
  • Call your doctor as soon as possible if any of these side effects occur:
  • Less common or rare:
  • Confusion or mental depression
  • Bloody or black, tarry stools
  • Swollen/ painful glands
  • Bloody urine
  • Unusual excitement (mild)
  • Pinpoint red spots on skin
  • Unusual bruising or bleeding
  • Muscle cramps or pain

Some side effects of butalbital and aspirin may not require medical attention. These side effects are likely to go away in the course of your treatment with the medication, as your system adjusts itself to the medicine. Ask for advice from your physician on the various ways you can reduce or prevent these side effects. Let your doctor know if the side effects below persist, or if you need some more information about them:

More common:

  • Nausea, vomiting, or abdominal pain (occurring without other overdosing symptoms)
  • Mild drowsiness
  • Bloated or gassy feeling
  • Mild dizziness or lightheadedness
  • Heartburn or indigestion

Very severe allergic reactions to this combination drug are rare. Seek medical help immediately if you notice any of these symptoms of an allergic reaction: itching, rash, swelling, dizziness and labored/troubled breathing.

Some patients may also experience some other side effects not listed here. It is advisable to check with your health caregiver as soon as possible if you experience any other side effects. You may also report your side effects to the FDA at 1-800-FDA-1088.

Dosage

To reduce stomach irritation, take this medication with a full glass of water or with food.

Do not use this medication if you smell a strong vinegar-like odor, which is an indication that the aspirin contained in it is breaking down. Check with your health caregiver if you have any questions about this.

Follow your doctor’s directions when using this medicine. Do not take larger doses, do not take it more frequently, and do not use it for longer than instructed by the doctor. Taking butalbital and aspirin combination regularly (for example, daily), may cause a physical or mental dependence because the drug is habit-forming. The caffeine contained in some combinations of butalbital and aspirin also increase the chances of dependence. Dependence is particularly likely to develop in patients using the drug to ease frequent headaches. Stomach problems and other medical conditions may also occur if you take too much of this medicine.

This medication is most effective if taken as soon as the headache starts. If you feel the signs of a migraine, take the medication once you’re sure a migraine is on its way. Doing this may stop the headache from occurring in the first place. Also try lying down in a dark, quiet room to relieve the headaches.

Patients who get headaches very frequently may need to use a different medication to prevent the headaches. Following your doctor’s instructions about using the other medication is important, even if the headaches keep occurring. These preventive medicines may take up to several weeks to start working. Your headaches, however, should come less often and should be less serious and easier to get rid of than before. Using such medications reduces the amount of headache relief medicines needed. If after several weeks you do not notice any improvements using headache-preventing medications, let your doctor know.

Dosing:

Dosage for medications in this category will vary from patient to patient. Follow your healthcare professional’s instructions or the directions provided on the label. The information provided below only indicates the average doses for this medicine. Do not change your dose if it is different unless instructed by your doctor.

The amount of medication you take will depend on the strength of the medicine. In addition, the number of doses to take each day, the intervals allowed between doses, and the prescription all depend on the medical condition for which you are taking the medicine.

  • For butalbital and aspirin combination tablets:
  • For relieving tension headaches:
  • Adults—one tablet every four hours as needed. Take no more than six tablets a day.
  • Children—the dose should be determined by the doctor.
  • For butalbital, aspirin, and caffeine combination (capsules or tablets):
  • For relieving tension headaches:
  • Adults—one or two tablets or capsules every four hours as needed. Take no more than tablets or capsules a day.
  • Children—the dose should be determined by the doctor.

Missed dose:

If you miss a dose, be sure take it the moment you remember. You can, however, resume your regular dosing schedule if it’s almost time to take your next dose. Do not try to make up for the missed dose by double dosing.

Overdose:

Call your local poison control center as soon as you suspect overdosing. If you are a US resident, contact the national poison hotline at 1-800-222-1222. If you are a Canadian resident, call your local poison center directly.

Major Drug Interactions

Although some medications should not be used together, there may be cases where they may be prescribed together even if an interaction could occur. In such cases, your doctor may need to change the dosage or give you certain precautions. When taking butalbital and aspirin combination, it is very important to let your doctor know whether you are also using any of the drugs listed below. The list of interactions provided is not necessarily all-inclusive—the medicines have been selected on the basis of their probable significance.

It is not recommended to use medications in this class with any of the following medications. Your physician may decide against prescribing this class of medications or they may change the dosing for the other drugs you are taking:

  • Defibrotide
  • Ketorolac
  • Riociguat
  • Influenza Virus Vaccine, Live
  • Dichlorphenamide

Using butalbital and aspirin combination with any of the medications highlighted below is usually not advised, but may in some cases be necessary. If your doctor prescribes both medicines together, they may decide to change the dosage or frequency of using one or both of the medications:

  • Piracetam
  • Ketazolam
  • Proglumetacin
  • Chlorzoxazone
  • Lornoxicam
  • Pranoprofen
  • Bufexamac
  • Etodolac
  • Bumetanide
  • Fepradinol
  • Dexibuprofen
  • Pemetrexed
  • Xipamide
  • Amobarbital
  • Celecoxib
  • Duloxetine
  • Carisoprodol
  • Phenylbutazone
  • Dibenzepin
  • Feverfew
  • Chlorthalidone
  • Lormetazepam
  • Proquazone
  • Dicumarol
  • Methocarbamol
  • Alteplase, Recombinant
  • Lumiracoxib
  • Salsalate
  • Flunitrazepam
  • Nepafenac
  • Meclofenamate
  • Fluoxetine
  • Cyclopenthiazide
  • Tolazamide
  • Nateglinide
  • Tirofiban
  • Clonazepam
  • Sulindac
  • Piperaquine
  • Propyphenazone
  • Oxaprozin
  • Prasugrel
  • Rivaroxaban
  • Acarbose
  • Methohexital
  • Nabumetone
  • Amitriptyline
  • Choline Salicylate
  • Argatroban
  • Mefenamic Acid
  • Clarithromycin
  • Clomipramine
  • Oxazepam
  • Milnacipran
  • Feprazone
  • Clonixin
  • Droxicam
  • Fluvoxamine
  • Glyburide
  • Flurbiprofen
  • Eplerenone
  • Lorazepam
  • Amineptine
  • Sertraline
  • Metformin
  • Flurazepam
  • Doxorubicin
  • Midazolam
  • Bendroflumethiazide
  • Tolmetin
  • Desvenlafaxine
  • Amiloride
  • Imipramine
  • Nimesulide
  • Ethchlorvynol
  • Tolbutamide
  • Chlordiazepoxide
  • Meloxicam
  • Ticlopidine
  • Aprobarbital
  • Triazolam
  • Venlafaxine
  • Bivalirudin
  • Phenobarbital
  • Lepirudin
  • Methotrexate
  • Anisindione
  • Doxorubicin Hydrochloride Liposome
  • Chloral Hydrate
  • Reteplase, Recombinant
  • Diazepam
  • Spironolactone
  • Flufenamic Acid
  • Ginkgo
  • Valdecoxib
  • Vilazodone
  • Ticagrelor
  • Paroxetine
  • Trichlormethiazide
  • Dothiepin
  • Diflunisal
  • Digoxin
  • Triamterene
  • Pralatrexate
  • Furosemide
  • Medazepam
  • Clopidogrel
  • Piroxicam
  • Varicella Virus Vaccine
  • Warfarin
  • Salicylic Acid
  • Meprobamate
  • Temazepam
  • Thiopental
  • Tolfenamic Acid
  • Niflumic Acid
  • Betrixaban
  • Sodium Oxybate
  • Estazolam
  • Nefazodone
  • Benzthiazide
  • Piketoprofen
  • Doxepin
  • Nitrazepam
  • Pentoxifylline
  • Tianeptine
  • Acemetacin
  • Dexketoprofen
  • Clobazam
  • Trimipramine
  • Clorazepate
  • Fenoprofen
  • Chlorpropamide
  • Oxyphenbutazone
  • Butabarbital
  • Edoxaban
  • Nortriptyline
  • Apixaban
  • Prazepam
  • Ketoprofen
  • Glimepiride
  • Nicorandil
  • Escitalopram
  • Loxoprofen
  • Alprazolam
  • Chlorothiazide
  • Primidone
  • Tiaprofenic Acid
  • Mephenesin
  • Metolazone
  • Desirudin
  • Butalbital
  • Cilostazol
  • Naproxen
  • Dabigatran Etexilate
  • Peginterferon Alfa-2b
  • Mephobarbital
  • Alipogene Tiparvovec
  • Diclofenac
  • Torsemide
  • Alfentanil
  • Morniflumate
  • Phenprocoumon
  • Clopamide
  • Lithium
  • Repaglinide
  • Cyclosporine
  • Pentobarbital
  • Tacrolimus
  • Treprostinil
  • Felbinac
  • Ulipristal
  • Darunavir
  • Ibuprofen
  • Desmopressin
  • Nimesulide Beta Cyclodextrin
  • Indomethacin
  • Etonogestrel
  • Rofecoxib
  • Phenindione
  • Fondaparinux
  • Hydrochlorothiazide
  • Protriptyline
  • Glipizide
  • Citalopram
  • Opipramol
  • Halazepam
  • Polythiazide
  • Sodium Salicylate
  • Eptifibatide
  • Bromfenac
  • Danaparoid
  • Metaxalone
  • Aceclofenac
  • Vortioxetine
  • Tenoxicam
  • Methyclothiazide
  • Protein C
  • Heparin
  • Etofenamate
  • Dantrolene
  • Dipyrone
  • Amitriptylinoxide
  • Gossypol
  • Etoricoxib
  • Secobarbital
  • Amtolmetin Guacil
  • Ethacrynic Acid
  • Amoxapine
  • Anagrelide
  • Hydroflumethiazide
  • Pixantrone
  • Floctafenine
  • Quazepam
  • Indapamide
  • Parecoxib
  • Diazoxide
  • Pentosan Polysulfate Sodium
  • Regadenoson
  • Nifedipine
  • Desipramine
  • Levomilnacipran
  • Lofepramine
  • Melitracen

This is not necessarily a complete list of all the possible drug interactions that can occur with butalbital and aspirin. Be sure to keep a list of all products you are using, including prescription and nonprescription medicines, herbal products and supplements. Show this list to your doctor or pharmacist at every appointment.

Food/alcohol/tobacco:

To avoid interactions from occurring, you may need to stop consuming certain foods. Using alcohol and tobacco could also cause interactions. Have a talk with your doctor about the use of alcohol or tobacco with your medicine.

Other medical conditions:

Having certain other medical problems could affect how this medication functions. Let your healthcare professional know if you have other medical conditions, particularly:

Mental depression

  • Severe heart disease —The caffeine in some drug combinations could make some kinds of heart conditions worse.
  • A history of Porphyria—taking butalbital may aggravate these conditions.

Kidney disease

  • Asthma, especially if it occurs together with other allergies and nasal polyps
  • Emphysema or any other chronic lung disease
  • Stomach ulcer, particularly with a history of bleeding, or other abdominal problems—use of aspirin may make the condition worse.
  • Hyperactivity (in children)
  • Diabetes mellitus
  • Alcohol abuse (or a history of)
  • Hemophilia or some other bleeding problem
  • Gout—Use of aspirin can worsen the condition and could also diminish the effects of some medications used to treat gout.
  • Hyperthyroidism (overactive thyroid)
  • Liver disease—chances of severe side effects may be increased.
  • A history of drug abuse or dependence (or history of)—patient could develop a dependence on butalbital.
  • Vitamin K deficiency—use of aspirin increases the chances of severe bleeding.

Warnings

Before you start using any medicine, it’s always important to weigh the potential risks of using it against the benefits it has to offer. Your doctor should help you make this decision. Take note of the following precautions before using butalbital and aspirin combination:

Allergies

Let your doctor know if you have ever had any allergic or unusual reaction to medications in this class or any other medications. You should also inform your healthcare giver if you have other types of allergies, such as to animals, preservatives or foods dyes, preservatives, or animals. Be sure to go through the package or label ingredients carefully when using non-prescription products.

Pediatric

Butalbital:

Though barbiturates like butalbital usually cause drowsiness, some children get excited after using them.

Aspirin:

Do not give a child with a fever or virus infection (especially chickenpox or flu) a medication that contains aspirin without first talking about its use with the child’s doctor. This is absolutely important since aspirin could cause a serious disease known as Reye’s syndrome in a child with fever resulting from a virus infection (especially chickenpox or flu). Children who have no virus infection could also be highly sensitive to aspirin’s effects, particularly if they have a fever or have been losing copious amounts of body fluids through diarrhea, vomiting or sweating. This might increase the chances of having side effects during their treatment.

Caffeine:

No specific information can be found that compares the use of caffeine in child patients up to age 12 with use in other age groups. Nevertheless, caffeine is not expected to bring about different problems or side effects in a child than it does in an adult.

Elderly patients

Butalbital:

Excitement, confusion or depression symptoms are especially likely to occur in geriatric patients, who usually happen to be more sensitive to the effects of butalbital than younger adults.

Aspirin:

Generally speaking, elderly patients are more sensitive to aspirin’s effects than younger adults. This could increase the chances of experiencing side effects during treatment.

Caffeine:

A significant number of medications have not been studied specifically in the elderly population. It has therefore not be established whether the medications work exactly the same way in young adults as they do in elderly adults or if they cause different problems or side effects in older people. No specific information is available comparing the use of caffeine in the geriatric population with use in other age groups.

Pregnancy

Butalbital:

In humans, butalbital and other barbiturates have been shown to increase the risk of birth defects. Additionally, another study in humans suggests that taking barbiturates during pregnancy could increase the risk of brain tumors in the fetus. Butalbital could cause breathing problems in the newborn child if taken just before or during birth.

Aspirin:

Though studies in humans have not established that aspirin can cause birth defects, it has been shown to cause birth defects in animal studies.

You are advised not to take aspirin within the last three months of your pregnancy, unless instructed by your doctor. According to various reports, using aspirin in the late stages of pregnancy could cause a decrease in the newborn baby’s weight, and possibly even death of the newborn or fetus. It should be noted, however, that the mothers in those reports had been taking larger doses of the drug than is typically recommended. Studies of women taking the usual recommended doses of aspirin did not show the same unwanted effects.

There is also a risk that regular aspirin use in the latter stages of pregnancy may bring about undesirable effects in blood flow or heart of the fetus or newborn baby. In addition, using aspirin in the final two weeks of pregnancy could lead to bleeding problems in the baby before or during delivery. Too much use of aspirin in the final three months of pregnancy may also increase the duration of your pregnancy, lengthen labor, cause other complications during delivery, or cause severe bleeding in the mother during, before, or after delivery.

Caffeine:

No studies in humans have shown that caffeine may cause birth effects. Using large amounts of caffeine while pregnant may however lead to problems with heart rhythm as well as the growth of the unborn baby. In addition, studies in animals show that caffeine can cause birth defects when administered in very big doses (amounts tested are the equivalent of 12 – 24 cups of coffee per day).

Breastfeeding

Though this combination medication has not been reported to cause any problems, there is always the chance, especially if the medication is taken in large quantities or for a long time.

Butalbital:

Butalbital and other barbiturates have been shown to pass into breast milk, and could cause drowsiness, uncharacteristically slow heartbeat, troubled breathing, or shortness of breath, in the nursing baby.

Aspirin:

Aspirin is known to pass into breast milk. However, use of aspirin in the amounts present in these drug combinations has not been shown to cause problems in the nursing babies.

Caffeine:

The caffeine contained in some of these combination medications passes into breast milk in tiny amounts. However taking caffeine in the quantities present in these medications has not been established to cause problems in babies. However, studies show that nursing babies might appear jittery and may have trouble sleeping when the mothers consume large quantities of beverages containing caffeine. For this reason, breastfeeding mothers who use medicines containing caffeine are advised to limit the amount of caffeine they consume from other medications or from beverages.

Check with your physician if the drug stops working as effectively as it did when you first started taking it. This could mean that you are at risk of becoming dependent on the medication. Do not try to increase the pain-relieving effects by increasing the dose.

Let your doctor know if you are getting headaches more frequently than you did before you started taking this medication. This is particularly important if you have a new headache within a day after taking your last dose of medication for headache relief, headaches start to happen every day, or you have a headache that persists for a number of days in a row. This could mean that you have a dependent for the headache medication. Continuing with this medication will later on cause even more headaches. Your doctor can advise you on how to relieve your headaches.

Check the labels of all over-the-counter (nonprescription) as well as prescription medications you are now taking. If any of them contain aspirin, a barbiturate or other salicylates, check with your healthcare giver. Using them together with this medication may cause an overdose.

The butalbital contained in this medicine will amplify the effects of alcohol and other central nervous system depressants (drugs that cause drowsiness by slowing down the CNS). Examples of CNS depressants include: sedatives, tranquilizers (sleep medications), antihistamines, pain medicines (narcotics), muscle relaxants or anesthetics, seizure medicines, other barbiturates. Additionally, you are likely to have stomach problems if you drink alcohol while you use aspirin. Avoid alcoholic beverages and consult your doctor before using any of the medications mentioned above while using butalbital and aspirin combination.

This medicine could cause drowsiness, dizziness, or lightheadedness in some people. Make sure you are aware how you react to this medication before driving, using machines, or doing anything else that might be dangerous if you are not clearheaded and alert.

Before you undergo any kind of surgery (dental surgery included) or emergency treatment, inform the doctor or dentist that you are using this medicine. Severe side effects might occur if your doctor or dentist prescribes certain other medicines without knowledge of your use of butalbital.

Avoid this medicine for five days prior to any scheduled surgery, including dental surgery, unless otherwise instructed by your doctor or dentist. Use of aspirin during this time may lead to bleeding problems.

Before having any medical tests, let the medical professional in charge know that you are taking this medication. The caffeine present in some combinations may interfere with the results of some tests that use dipyridamole (such as Persantine) to help indicate how well blood flows to your heart. Do not take caffeine 8 – 12 hours before the test. Some other test results could also be affected by this drug combination.

If you have been using this medication regularly for a number of weeks, or if you have been taking large quantities of the medication, do not stop using it abruptly without first consulting your doctor. Your doctor may need to gradually reduce your doses before you can stop completely, to reduce the chances’ of withdrawal side effects.

If you believe you or someone else may have taken an overdose of this medication, immediately call for medical attention. An overdose of this medication or use of CNS depressants or alcohol with this medication could cause unconsciousness or even death. Overdosing symptoms include: seizures (convulsions), confusion, severe restlessness, nervousness, or excitement, buzzing or ringing in the ears, hearing loss, severe drowsiness, severe dizziness, difficulty breathing or shortness of breath, and severe weakness.

Storage

Store this medication at room temperature, away from light, excess heat and moisture. Be sure to keep the medication tightly sealed in its original package, out of the sight and reach of children or pets.

Do not flush leftover medication down the toilet or the drain unless directed to do so. The best way to dispose of leftover medicines is through a take-back program. Ask your pharmacist or speak to your local garbage and recycling department to learn more about the take-back programs in your community. If you cannot access a take-back program, check the FDA's Safe Disposal of Medicines website for more information.

Summary

Butalbital and aspirin is used for relieving tension headaches and other types of pain. It is worth noting that use of butalbital for long periods, could build up tolerance to the medication, causing you to progressively require larger doses. Additionally, butalbital may become habit-forming, leading to psychological or physical dependence if used for long or in large doses. Be sure to check with your physician if the drug being as effective as it was when you first started taking it.

Before taking butalbital and aspirin, it is important to let your doctor know about other medications you are using. In particular, avoid medicines containing aspirin, a barbiturate or other salicylates, while using this drug combination, as using them together may cause an overdose. And if you suspect an overdose, do not hesitate to call for emergency medical attention. In addition, avoid taking CNS depressants (drugs that cause drowsiness by slowing down the central nervous system) or alcohol with this medicine, as butalbital can increase the effects of these drugs, leading to serious problems.

If you are pregnant or nursing a baby, do not use medications in this class without consulting your doctor. Various studies have shown that the ingredients present in this medicine (butalbital, aspirin and caffeine) are potentially harmful to the unborn baby, especially if the mother takes large doses of the medication.

Resources
Last Reviewed:
January 31, 2018
Last Updated:
January 27, 2018