Fioricet Precaution

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People who suffer from tension-type headaches that do not respond to over-the-counter (OTC) medications may find relief with combination drugs that include butalbital.  Commonly prescribed as Fioricet (butalbital/acetaminophen/caffeine) or Fiorinal (butalbital/aspirin/caffeine), butalbital is a sedative in the barbiturate class of medicines. Although the drug causes intense relaxation and eases the pain of a tension headache, it is not without risks.

The most common type of headache disorder, a tension headache occurs when neck and scalp muscles become tense, or contract, meaning they squeeze down. This causes pain, often described as a rubber-band-around-the-head feeling or a pressure sensation, on both sides of the head.

Tension headaches can be triggered by a number of factors including stress, hunger, lack of sleep, anxiety, and temperature changes. They may occur at any age but are most common in adults and older teens. Some people are more prone or vulnerable to developing tension headaches than others, although the reason behind this is not very clear.

Most tension headaches are mild in pain and can be easily alleviated with rest, fluids, removal of the trigger, and/or an over-the-counter medication like Motrin (ibuprofen) or Tylenol (acetaminophen). Behavioral therapies too can be effective like physical therapy or cognitive-behavioral therapy.1

Butalbital

When recurring tension headaches do not respond to other treatments, your doctor may prescribe Fiorinal or Fioricet. Codeine may also be added to this combination of medicine. While this medication is very effective in the short-term, there are some things to watch out for.

Butalbital is a barbiturate, which means that it helps to slow down the central nervous system and relax the muscle tension believed to be associated with tension headaches.

Before taking medication containing butalbital, tell your doctor if you:

    • Are allergic to any ingredients in the medication, such as acetaminophen or aspirin.
    • Are currently taking blood thinners, antidepressants, antihistamines, or other sedatives such as sleeping pills or tranquilizers
    • Have or previously had liver disease, porphyria, or depression
    • Are pregnant, plan to become pregnant, or are currently breastfeeding

Dosing

Always take these medications as prescribed by your doctor. According to the manufacturer, the typical dose for Fioricet or Fiorinal is one to two tablets, every four to six hours as needed, not to exceed six tablets per day. These drugs should not be taken more than twice a week, as extended and repeated use of butalbital can lead to physical dependence.

      • Fioricet contains 50 milligrams (mg) butalbital, 300 mg acetaminophen, and 40 mg caffeine.

Side Effects

Fioricet and Fiorinal should be taken with food or milk to prevent gastric problems. The following side effects have been reported in people taking medications containing butalbital:

      • Confusion
      • Depression
      • Drowsiness
      • Lightheadedness
      • Stomach pain
      • Upset stomach
      • Vomiting

More serious side effects may occur and could be signs of an allergy or serious complications. See your doctor immediately if you experience any of the following:

      • Difficulty breathing
      • Itching
      • Rash

Risks

Butalbital-containing medications can be habit-forming and may lead to addiction and other problems. Risks of taking Fioricet and Fiorinal include:

Intoxication

Butalbital slows the central nervous system, leading to lack of coordination, problems with thinking and memory, slowness of speech, disinhibition, and emotional disturbances. Do not drive or operate heavy machinery while taking medicines containing butalbital.

Medication Overuse Headache

A medication-overuse headache (MOH), once known as a rebound headache, drug-induced headache, or medication-misuse headache, is a chronic headache that develops as a result of prolonged and frequent use of certain medications for acute headaches. Such headaches are a common side effect of a number of classes of medications used to treat headaches.5

According to the International Classification of Headache Disorders, MOH is diagnosed when a person has a headache 15 or more times a day and, in the case of combination pain relievers like Fioricet and Fiorinal, has been taking the drug for 10 days a month for more than three months.6

In addition, medication overuse headaches are often not responsive to preventive headache medications. This lack of response to other medications is often a clue to doctors that a medication overuse headache has developed.

Medications containing butalbital should be limited to two days per week to avoid this rebound effect.7

Withdrawal

When taking butalbital, you may experience withdrawal symptoms within eight to 36 hours after the last dose. Withdrawal symptoms may include anxiety, muscle twitching, tremor, weakness, dizziness, nausea and vomiting, insomnia, weight loss, and even seizures when the medication is discontinued.

Due to the risk of seizures with a withdrawal from butalbital, medical treatment in a monitored setting under the care of a physician is indicated.

Tolerance and Addiction

Tolerance and addiction may also occur with butalbital. Tolerance means that a person needs more of the medication to achieve headache relief. Addiction to butalbital is characterized by persistent behaviors, like compulsions, to take a butalbital-containing medication.

These behaviors impair their life in some way, negatively impacting relationships and/or everyday functioning.

Acetaminophen Overdose

Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.

Fioricet Precaution

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Tell your doctor your medical history, especially of: serious liver disease, alcohol or narcotic dependence, emotional/mental conditions, heart disease (arrhythmias, recent MI), stomach/intestinal ulcers, any allergies.

Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information.

To prevent oversedation, avoid using alcohol and other sedative type medications while taking this. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages.

This medication contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur.

This medication should be used during pregnancy only if clearly needed. Small amounts of this medication appear in breast milk. Consult your doctor before breast-feeding.

Check with your doctor:

  • If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
  • If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate or acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.

The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. 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 dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital and acetaminophen combinations.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.

If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.