Butalbital/acetaminophen/caffeine is a combination product used for treating headache.  It is generally called Fioricet.

What Fioricet is Used For ?

Butalbital is a narcotic that depresses the central nervous system.

Acetaminophen is a pain reliever and fever reducer. It is the active compound in Tylenol. Acetaminophen relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before a person feels it. It reduces fever through its action on the heat-regulating center of the brain. Specifically, it tells the center to lower the body’s temperature when the temperature is elevated.

Caffeine has pain relieving properties and may boost the action of other pain relievers by mechanisms that are not well understood. It may reduce the activity of pain sensing nerves in the brain. The FDA approved butalbital/acetaminophen/caffeine in November 1984.

Patients taking combination drugs of butalbital, acetaminophen, and caffeine should review the patient safety information such as specific side effects, drug interactions, and pregnancy safety for each of these drugs.

Acetaminophen/butalbital, sold under the brand name Fioricet among others, is a combination medication used to treat tension headaches and migraine headaches. It contains butalbital, a barbiturate and paracetamol (acetaminophen), an analgesic. Some versions also contain caffeine. It is taken by mouth.

The most common side effects include sleepiness, dizziness, trouble breathing, and abdominal pain. Other severe side effects may include liver problems, confusion, addiction, and allergic reactions.

Frequent use may result in medication overuse headache. Barbiturate withdrawal may occur if rapidly stopped following long term use. Use is not generally recommended during pregnancy or breastfeeding.

The combination was approved for medical use in the United States in 1984. It is available as a generic medication. In the United States the wholesale cost is about 1.20 USD per dose as of 2019.

In 2016 it was the 202nd most prescribed medication in the United States with more than 2 million prescriptions. In the United States it is a schedule III controlled substance in some states but not federally. It is banned in a number of European countries.

Fioricet Mechanism of action

Butalbital exerts a generalized depressant effect on the central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite that acts at cannabinoid receptors. Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital

Before taking Fioricet

Do not use Fioricet 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 Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure Fioricet 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 Fioricet 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.

Fioricet Side Effects

Along with its needed effects, acetaminophen/butalbital/caffeine 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 while taking acetaminophen / butalbital / caffeine:

More common

• Lightheadedness
• shortness of breath

Incidence not known

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed or dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• increased hunger
• increased thirst
• increased urination
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine:

Symptoms of overdose

• Confusion as to time, place, or person
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• pale or blue lips, fingernails, or skin
• restlessness
• sudden decrease in the amount of urine
• sweating
• trouble sleeping
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood
• yellow eyes or skin

Some side effects of acetaminophen / butalbital / caffeine 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:

More common

• Relaxed and calm
• sleepiness

Incidence not known

• Anxiety
• bloated
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• earache
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• full feeling
• hearing loss
• heartburn
• heavy eyelids
• high energy
• hot spells
• hyperventilation
• irritability
• numbness
• pain in the leg
• passing gas
• sluggishness
• stuffy nose
• tingling sensation

Fioricet Patient Reviews