Fioricet & Fiorinal for Headaches: Benefits and Risks

A drug with a high risk of addiction

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People who suffer from tension headaches that do not respond to over-the-counter (OTC) medications may find relief with combination drugs that include butalbital

Butalbital is not available as a single agent, but it is commonly prescribed as Fioricet and Fiorinal. It is a barbiturate sedative. In 2022, the Drug Enforcement Agency—responsible for the rules that govern access to these drugs—said it plans to put all forms into a more tightly controlled Class III category.

This article explains butalbital use and why the drug offers benefits but also risks. It talks about why you should only use butalbital products provided by prescription from your healthcare provider.

A woman with a headache in bed
Agnieszka Marcinska / EyeEm / Getty Images

Uses

Butalbital combination drugs are strong pain relievers used in the treatment of tension headaches, but typically not for migraines. Its use in people with these headaches is not uncommon but it also comes with some cautions.

Among the drugs used to treat headaches severe enough to send people to the emergency department, one study found butalbital was used 2% of the time for care in the hospital and prescribed 5.3% of the time for continued treatment in people being discharged.

However, the same study finds that butalbital use should be limited in favor of alternatives. That's because of the higher risk of medication overuse headaches, sometimes called rebound headaches. They're caused by relying too heavily on medication to relieve headache symptoms.

Butalbital combination drugs also may lead to intoxication, drug dependency, and withdrawal syndrome.

Fiorinal and Fioricet are medications used to bring relief to people experiencing tension headache pain. These butalbital medications have significant risks, though, and in many cases your healthcare provider may recommend an alternative.

Tension Headaches

tension headache is the most common type of headache disorder. It 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 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. They can be easily managed by:

  • Getting rest
  • Drinking more fluids to limit dehydration
  • Removing any known environmental causes
  • Taking an OTC medication like Motrin (ibuprofen) or Tylenol (acetaminophen)
  • Trying physical therapy or cognitive-behavioral therapy

What Is Butalbital?

When recurring tension headaches do not respond to other treatments, your healthcare provider may prescribe Fiorinal or Fioricet. They are two different kinds of butalbital combination drugs.

Fioricet includes butalbital with acetaminophen and caffeine. Fiorinal is made with butalbital, aspirin, and caffeine. Both drug combinations may have codeine added to them in some forms. The codeine is an opiate drug, and it increases the risks of addiction and potential overdose.

Because butalbital itself is a barbiturate, it relaxes the muscle tension believed to be associated with tension headaches. It also slows down your central nervous system by acting on a specific neurotransmitter, or chemical messenger, responsible for activating nerve impulses.

It's important that your healthcare provider know what medications you already take before you start a butalbital combination drug. Let them know 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 depression, liver disease, or porphyria, a rare metabolic condition
  • Are pregnant, plan to become pregnant, or are currently breastfeeding

Butalbital has the potential to interact with hundreds of drugs. They include Depakote (valproate) used to treat seizures and bipolar disorders, and duloxetine, an anti-anxiety drug. Be sure your healthcare provider knows what medications you take before starting Fioricet or Fiorinal.

Dosage

Always take these medications as prescribed by your healthcare provider. Be aware that extended and repeated use of butalbital can lead to physical dependence.

Fiorinal tablets were discontinued by the manufacturer, so it is now available only in capsule form. The capsules contain 50 milligrams (mg) butalbital, 325 mg aspirin, and 40 mg caffeine.

One or two capsules of Fiorinal may be taken every four hours as needed. The total daily dosage is limited to six capsules. It should not be taken more than twice a week.

Fioricet is available in tablet or capsule form. It contains 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine.

One or two tablets or capsules of Fioricet may be taken every four hours as needed. The total daily dosage is limited to six capsules, and its use should be limited to twice a week.

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
  • Nausea
  • Vomiting

More serious side effects may occur and could be signs of an allergy or serious complications. See your healthcare provider 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. It's important that you understand the risks of taking Fioricet and Fiorinal.

Intoxication

Because butalbital slows the central nervous system, it can present risks. You should not drive or operate heavy machinery while taking medicines containing butalbital. Watch for symptoms that include:

  • Lack of coordination
  • Problems with thinking and memory
  • Slowness of speech
  • Loss of inhibitions, meaning you may engage in risky behaviors you typically don't
  • Emotional disturbances

Medication Overuse Headache

A medication-overuse headache (MOH), once known as a 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.

These headaches are a common side effect of butalbital, as well as a number of classes of medications used to treat headaches.

An 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.

Often, people with an MOH do not get pain relief from preventive headache medications. This lack of response is often a clue to healthcare providers that an MOH has developed.

Research suggests that butalbital combination drugs may lead to MOH headaches in just one year if they are taken only five times or more per month.

Medication-overuse headache (MOH) occurs often with butalbital combination drugs. They are caused by frequent and repeated use of Fioricet or Fiorinal.

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 or tremors
  • Confusion
  • Dizziness
  • Nausea and vomiting
  • Insomnia
  • Weight loss
  • Seizures

Butalbital is one of the barbiturate drugs that may cause the most severe withdrawal symptoms, including seizures, delirium, and the collapse of your cardiovascular (heart and circulatory) system. These may be life-threatening symptoms and require monitoring by a healthcare provider.

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.

Acetaminophen Overdose

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

Why DEA Places Tight Controls on Butalbital Drugs

Fiorinal has long been treated as a Class III drug, but Fioricet was exempted because it contains acetaminophen. The logic was that the potential for liver damage would limit the abuse of Fioricet. That's not been the case, and 15 states already treated both as a more tightly controlled drug. But there has been less control of Fioricet because of access through Internet sales, without a prescription, that have led to drug abuse and drug arrests. Both products will continue to be available when prescribed by your healthcare provider.

Precautions

Both Fiorinal and Fioricet can cause complications in some people, in addition to the potential for abuse, addiction, and potentially life-threatening overdose or withdrawal symptoms. These risks are different based on the substance within the drug combination.

Acetaminophen

People who are sensitive to acetaminophen may experience an allergic reaction, and in rare cases a life-threatening form called anaphylaxis.

Butalbital

People with chronic renal (kidney) problems may have difficulty with butalbital in either of the two drugs. This is because butalbital is primarily cleared from the body through your kidneys. The acetaminophen also stresses the kidneys and may lead to early renal failure.

People with respiratory illnesses including sleep apnea, asthma, and chronic obstructive pulmonary disease (COPD) are at higher risk when taking butalbital because it depresses breathing function through its impacts on the nervous system.

In the Fiorinal form, the aspirin may add to breathing problems.

Codeine

When codeine is added to butalbital combination drugs, it may present risks to older people. It also may cause symptoms, some serious, in people with underlying medical conditions that include:

Your healthcare provider can help you to understand if butalbital combination drugs are safe for you, based on your overall health status, and prescribe the right product for your tension headaches.

Summary

Fioricet and Fiorinal are medications known as butalbital combination drugs. The Fioricet form includes acetaminophen and caffeine, while Fiorinal includes aspirin and caffeine. Codeine, an opiate, is added in some forms of these drugs.

They are powerful pain relievers for people who experience frequent tension headaches, but they also present significant risks because butalbital is a barbiturate drug. Both Fioricet and Fiorinal can lead to addiction, medication overuse headaches, intoxication, withdrawal, and overdose.

Because of these risks, you may wish to consider alternative treatments. That's especially true if you have other health issues that put you at risk.

A Word From Verywell

Fioricet and Fiorinal have brought pain relief to many people who find tension headaches a challenge to their quality of life. Yet they present serious risks, so be sure to use these drugs only under the guidance of your healthcare provider.

Frequently Asked Questions

  • Can you take butalbital alone?

    No, because it is only sold in a combination form. Fiorinal is made with butalbital, aspirin, and caffeine. Fioricet is made with butalbital, acetaminophen, and caffeine. Butalbital is no longer available as a single agent, and both Fiorinal and Fioricet are being placed under increasingly strict control by the Drug Enforcement Agency and those of individual states.

  • Can I take Fioricet or Fiorinal if I am pregnant?

    It depends on which form of the drug you use, and the advice of your healthcare team. For example, the FDA says it remains unknown if taking Fiorinal with Codeine presents a risk to mother or fetus, but that it should only be given when clearly needed. Researchers know that butalbital crosses the placenta and your child could develop a drug dependency, and there is some evidence that its use is linked to congenital (born-with) heart defects, but more study is needed. An alternative may be the better option.

  • Are butalbital drugs safe for children?

    You'll want to speak to your pediatrician about giving butalbital combination drugs to children. That said, Fioricet may be given to children and teens over age 12 at the same doses as adults. Safe use in younger children is not established, and it remains unknown for all ages 17 and under for Fiorinal. Some researchers suggest that no child should be given butalbital and alternatives should be used.

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