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
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
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.2
- Fiorinal contains 50 mg butalbital, 325 mg aspirin, and 40 mg caffeine.
Downsides of Taking Fioricet
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Dizziness, drowsiness, lightheadedness, sedation, shortness of breath, nausea, vomiting, abdominal pain, or an intoxicated feeling are the most commonly reported side effects.
- Other side effects, such as constipation, excessive sweating, itch, serious skin reactions, and mental confusion are less common.
- Butalbital is habit-forming and there is a high risk of dependence with extended and repeated use of Fioricet. Therefore it is not considered a first-choice medicine for headaches.
- May cause medication-overuse headache with repeated use and a withdrawal syndrome upon discontinuation.
- The potential for liver damage with the acetaminophen component exists, even at recommended dosages. The risk is increased with higher dosages, with chronic alcohol use, with some medications, and in patients with significant liver disease.
- May not be suitable for some people, including the elderly and people with kidney or liver disease.
- Although Fioricet may be prescribed for migraine headaches, it is not FDA approved for this and evidence does not support its use for migraine.
- Should not be used during pregnancy or breastfeeding.
- May interact with a number of other medications including those that also cause sedation such as opioids, benzodiazepines, and sedating antihistamines. Alcohol should be avoided.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
Side Effects of Taking Fioricet
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:
- Stomach pain
- Upset stomach
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:4
- Difficulty breathing
Risks of Taking Fioricet
Butalbital-containing medications can be habit-forming and may lead to addiction and other problems. Risks of taking Fioricet and Fiorinal include:
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.
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.
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.
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.
Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.