Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substances Act (CSA).
Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.
Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.
When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.
This medicine is available only with your doctor’s prescription.
While Fioricet can be an effective and life-changing medication for people suffering from tension headaches, there is also the risk of Fioricet abuse or addiction. It’s important to consider the possible side effects and risks of using Fioricet to determine if this drug is right for you.
What is Fioricet?
People who suffer from tension headaches may receive a prescription of Fioricet. Fioricet includes three different drug ingredients that can help manage different symptoms of tension headaches. These include:
- Butalbital: A type of barbiturate that can help muscle relaxation.
- Acetaminophen: Also called paracetamol (sold as Tylenol) and helps to relieve pain.
- Caffeine: Enhances the effects of acetaminophen.
The ingredients of Fioricet help to address pain specifically or can help to enhance the effects of the painkillers. Some types of Fioricet include codeine, which is an opiate used to treat pain. This can increase the effect of Fioricet, but also increase some of the risks for misuse or addiction.
Is Fioricet a Controlled Substance?
Fioricet is a controlled substance, which means that it requires a prescription and cannot be purchased over the counter. Fioricet can only be prescribed a certain number of times following a Fioricet prescription schedule. This is to avoid abuse or dependence and to reduce the risk of addiction.
Fioricet is a prescription combination drug that contains acetaminophen, butalbital, and caffeine. It is used to treat chronic tension headaches and works by relaxing muscle contractions that cause headache pain, stimulating the brain’s production of gamma-aminobutyric acid (also called GABA), increasing blood pressure to improve blood flow, and reducing the activation of pain signals in the nervous system.
Butalbital, one of the main active ingredients in Fioricet, is classified as a barbiturate and acts as a sedative in the body. It is a Schedule II drug in America, meaning it has a relatively high potential for abuse, dependence, and addiction. The other active ingredients in Fioricet are caffeine, which is a central nervous system stimulant, and acetaminophen, which is a pain and fever reducer.
Fioricet is generally taken by mouth with or without food every four hours as needed.2 People who take Fioricet may be at risk of developing tolerance, physical dependence, or addiction, especially if they take the drug excessively. It can also cause dangerous side effects or an overdose if it is abused. Due to the high risk of addiction, many doctors will prescribe other over-the-counter headache relief medications before prescribing Fioricet.
Butalbital is also sold under the brand name Fiorinal (aspirin, butalbital, and caffeine) and may sometimes be used to treat migraines.
Slang for Fioricet
The following terms are street names or slang for barbiturates, such as butalbital:
- Red devils
How Common Is Fioricet Abuse and Addiction?
According to the 2018 National Survey on Drug Use and Health (NSDUH), an estimated 6.4 million people ages 12 or older misused prescription tranquilizers, including barbiturates like Fioricet, in the past year. That’s equivalent to 2.4 percent of the population.3
Although the risks of becoming addicted to Fioricet are low, especially if you take the medication exactly as prescribed, it can still happen. The risks of addiction rise significantly when a person becomes physically dependent on Fioricet and develops a tolerance. At this point, he or she will need more of the drug to get relief from headaches. However, continually taking larger or more frequent doses of Fioricet can cause addiction.
Consuming large amounts of Fioricet can also produce a high that feels similar to being drunk, which may serve as motivation to misuse it. Some people use Fioricet recreationally by taking large doses of it to get high or by using it with opioids or prescription painkillers to enhance its effects.
Misusing Fioricet to get high or using it in any way other than how it was prescribed can have serious consequences like tolerance, dependence, addiction, and withdrawal. Once you are addicted, it can be very difficult to stop using it.
What Does Fioricet Look Like?
Fioricet comes in a pill or tablet form and is taken orally. It can also come as a liquid solution, but this is less common. The dose of the medication will be indicated on the tablet packaging or bottle.
Alternative Names for Fioricet
The combination of butalbital, acetaminophen and caffeine has been formulated by different pharmaceutical brands and can be known by different names in different places.
- Brand Names: The combination of butalbital, acetaminophen and caffeine is sold under other brand names, as well as Fioricet. These include Americet, Ezol and Alagesic among others.
- Generic Names: Fioricet may be referred to as the generic names of the drugs combination (butalbital, acetaminophen and caffeine)
- Street Names: There are few known street names for Fioricet that does not contain codeine, as it is lower risk for abuse and addiction. Barbiturates, a drug component of Fioricet, may be referred to simply as Barbs.
What is the most important information I should know about Fioricet (Acetaminophen, Butalbital, And Caffeine)?
Do not use this medicine 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 acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
To make sure acetaminophen, butalbital, and caffeine is safe for you, tell your doctor if you have:
- liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
- kidney disease;
- asthma, sleep apnea, or other breathing disorder;
- stomach ulcer or bleeding;
- a history of skin rash caused by any medication;
- a history of mental illness or suicidal thoughts; or
- if you use medicine to prevent blood clots.
It is not known whether this medicine 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.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Calcium Oxybate
- Chloral Hydrate
- Gabapentin Enacarbil
- Magnesium Oxybate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Potassium Oxybate
- Sodium Oxybate
- Tolonium Chloride
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Depression, history of or
- Lung or breathing problems (eg, respiratory depression) or
- Mood or mental changes, history of—Use with caution. May make these conditions worse.
- Kidney disease (eg, patients receiving dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using Gralise® tablets:
- These should be taken with the evening meal.
- Swallow the tablet whole. Do not crush, break, or chew it.
For patients with epilepsy who take gabapentin three times per day, do not allow more than 12 hours to pass between any 2 doses. The medicine works best if a constant amount is in the blood.
Neurontin® capsules, tablets, and solution may be taken with or without food.
You may break the scored Neurontin® tablets into two pieces, but make sure you use the second half of the tablet as the next dose. Do not use the half-tablet if the whole tablet has been cut or broken after 28 days. Ask your doctor or pharmacist if you have any questions.
Swallow the capsule whole with plenty of water. Do not open, crush, or chew it.
Measure the oral liquid using a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
If you take an antacid that contains aluminum or magnesium, wait at least 2 hours before taking gabapentin. Some examples of these antacids are Di-Gel®, Gaviscon®, Gelusil®, Maalox® and Mylanta®.
Only use the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (capsules, liquid, and tablets):
- For epilepsy:
- Adults and children 12 years of age and older—At first, 300 milligrams (mg) three times per day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1800 mg per day (600 mg three times per day).
- Children 3 to 11 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight per day and divided in 3 doses. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 3 years of age—Use and dose must be determined by your doctor.
- For postherpetic neuralgia:
- Adults— At first, 300 milligrams (mg) as a single dose in the evening. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1800 mg per day.
- Children—Use and dose must be determined by your doctor.
- For epilepsy:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You should store the Neurontin® oral liquid in the refrigerator. Do not freeze.
It is very important that your doctor check your progress at regular visits, especially in the first few months if you have epilepsy. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Check with your doctor right away if you have a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin. These may be symptoms of a serious and life-threatening allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Gabapentin may cause vision changes, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, other medicines for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are using gabapentin.
This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or troubled breathing, or irregular, fast or slow, or shallow breathing.
Do not stop using gabapentin without checking with your doctor. Stopping the medicine suddenly may cause seizures. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Clumsiness or unsteadiness
- continuous, uncontrolled, back-and-forth, or rolling eye movements
More common in children
- Aggressive behavior or other behavior problems
- concentration problems and change in school performance
- false sense of well-being
- hyperactivity or increase in body movements
- rapidly changing moods
- reacting too quickly, too emotional, or overreacting
- suspiciousness or distrust
- Black, tarry stools
- chest pain
- depression, irritability, or other mood or mental changes
- loss of memory
- pain or swelling in the arms or legs
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Abdominal or stomach pain
- blistering, peeling, or loosening of the skin
- clay-colored stools
- dark urine
- decreased urine output
- difficult or troubled breathing
- fast or irregular heartbeat
- increased thirst
- irregular, fast or slow, or shallow breathing
- itching or skin rash
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- muscle ache or pain
- pale or blue lips, fingernails, or skin
- red skin lesions, often with a purple center
- red, irritated eyes
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Blurred vision
- cold or flu-like symptoms
- lack or loss of strength
- lower back or side pain
- swelling of the hands, feet, or lower legs
- trembling or shaking
Less common or rare
- Accidental injury
- appetite increased
- back pain
- bloated or full feeling
- body aches or pain
- burning, dry, or itching eyes
- change in vision
- change in walking and balance
- clumsiness or unsteadiness
- cough producing mucus
- decrease in sexual desire or ability
- dryness of the mouth or throat
- excess air or gas in the stomach or intestines
- excessive tearing
- eye discharge
- feeling faint, dizzy, or lightheadedness
- feeling of warmth or heat
- flushed, dry skin
- flushing or redness of the skin, especially on the face and neck
- frequent urination
- fruit-like breath odor
- impaired vision
- increased hunger
- increased sensitivity to pain
- increased sensitivity to touch
- increased thirst
- noise in the ears
- pain, redness, rash, swelling, or bleeding where the skin is rubbed off
- passing gas
- redness or swelling in the ear
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- tender, swollen glands in the neck
- tightness in the chest
- tingling in the hands and feet
- trouble sleeping
- trouble swallowing
- trouble thinking
- unexplained weight loss
- voice changes
- weakness or loss of strength
- weight gain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.